chrisvoncsefalvay/vaers-outcomes huggingface dataset:
under 18 years; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years). On 14-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment medication was reported no concomitant drugs are reported   This case was linked to MOD-2021-272958 (Patient Link).
Report of facial swelling the next day after the new bivalent vaccine booster received yesterday.  She went to urgent care today 9/20 later in the morning after going to work because her lips were swollen at first but it moved to more of her whole face.  She took Benadryl at home for the lips and then went to the urgent care where she received a steroid injection in her buttocks and a prescription to take oral steroid to tapper down.  She had no other symptoms and is feeling fine otherwise.  She has not had any history facial fillers or injections.  Doing fine now and waiting for swelling to go down. 9/21/2022 swelling resolved.
No symptoms was administered outside the EUA for Moderna. Notified State of Nebraska VFC program who notified CDC. Was advised by CDC to Finish the Series.  1st Dose 3/12/2021                  2nd Dose 5/10/2021
Developed low-grade fever 8/27/10 pm that continued thru Saturday. Sunday developed rash to neck, chest, and back (8/29). Also has runny nose and cough but grandmother sates has had that since before MMR vaccine. Took to doctor last night & diagnosed with "measles". Lesions in mouth also.
The patient was given the Moderna Booster Bivalent Vaccine on the date of service. When vaccine was entered into GRITS it was entered as a Monovalent vaccine. There was no adverse event.
This spontaneous report as received from a nurse via a company representative refers to a 51 year old female patient. The patient's pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On 01-FEB-2017, the patient was vaccinated with ZOSTAVAX in the left arm (route, strength, dosage schedule, lot # and expiration date were not reported) as prophylaxis. On an unspecified time (In February 2017), after receiving vaccination with ZOSTAVAX, the patient developed a "blistering rash along the backside of the left arm" (rash vesicular).  It was reported that on 04-FEB-2017, the patient was seen by physician assistant for the "blistering rash" and was prescribed a medrol pak and acyclovir as treatment. At the reporting time, the outcome of rash vesicular was unknown. The reporter did not assess causality between the rash vesicular and the vaccination with ZOSTAVAX. There was no product quality complain (PQC) involved.  This is one of two reports from the same reporter. Additional information is not expected as there was no consent to contact.; Sender's Comments: US-009507513-1702USA002822:
Information has been received from a health care worker concerning a 70 year old female who on 9/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Concomitant therapy included influenza virus vaccine (unspecified), it was unknown when the flu shot was given. On 9/30/04, the patient developed lymph node swelling and fever. It was noted that one patient had gone to the emergency room. It was also noted that the patient was hospitalized. The outcome was not recovered. The reporter also mentioned 4 other female patients who were also vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed similar reactions. No product quality complaint was involved. Lymph node swelling and fever were considered to be immediately life threatening and disabling. Additional information has been requested.  Follow up on 10/18/04 states: "The pt was seen in the ER. It was also noted that the pt was hospitalized.  At the time of the report, the pt had not recovered. The reporter expressed concern with Lot # 0740N.  Lymph node swelling and fever were considered to be immediately life-threatening and disabling. Additional information has been requested." Follow up 03/03/05: Patient has not recovered from the adverse event(s).
Large red welt at injection site "with head," itching at injection site, sore throat, sneezing, nasal congestion, mucousy cough.
Within 10-15 minutes after receiving the vaccine, the patient complained of nausea and was very white and clammy. When observing her, she appeared like she was going to fall over so I had her mom help me put her on her back. 911 was called and I took her blood pressure and it was 80/49 mmHg. She remained conscious and EMS took her to ED for observation. She was given liquids, discharged and told to come back if she had any other symptoms. Per her mother, she had not ate or drank anything prior to receiving the shot.
The pt had profuse vomiting and diarrhea, simultaneously, every 2 hours (3 times) on the morning following Hep-A shot. Then she had muscle pain in her lower back migrating upward on the right and moving to left kidney, down left leg to buttock, thigh and behind knee to calf.
Patient had ZOSTAVAX on 11/18/2014 at pharmacy. Very dizzy 2 hours after vaccine. Developed nausea and 1 episode of vomiting. Felt weak on 11/19/2014 A.M. Rash at injection site. No oral lesions.
Joint swelling every month knees, wrists, elbows; related to monthly periods; started 6APR91; pt seen by MD about joint swelling;
Initial information was received on 25 August 2014 from a healthcare provider. It represents one of a cluster of four patients reported by the same reporter who each experienced an adverse event following administration of ADACEL, lot number U4902BA. The events for the other three patients are captured in case number 2014SA101259. A 12 year old male patient was vaccinated into the left deltoid on 25 July 2014 with a first dose of ADACEL, lot number U4902BA, route of administration not reported. On 26 July 2014, the patient experienced injection site cellulitis. The patient was not ill at the time of vaccination and had no pre-existing physician-diagnosed allergies or medical conditions. Other medications were reported as none. He was treated with antibiotics and was evaluated by a physician. The patient outcome is recovered on an unspecified date. Note: The other three unidentified patients are captured in case number 2014SA101259. Documents held by sender: None.
A few days after injection I started to itch. Itching would come and go no specific triggers from environment, no new pets or clothes or any new substances in my environment. Itching would start in one place and appear red, after scratching it would become hives and then dissipate and reappear elsewhere on body in no specific pattern. Entire body has inflammatory response to something. My scalp would itch intensely to the point where I could not think straight or function. My hands were itching and palms dry and red, every crevice on my body would itch no spot seemed to be left untouched except my face and vulva, my bikini line would itch, my back, buttocks, under the breast, hands, legs, arms, my entire body felt like it was on fire with a tingly and itchy sensations and hives appearing all over and disappear and continuing the viscous cycle. The heat agitated my already itchy skin and sweat made it worse, I would sleep naked drenched in calamine plus lotion just to get an hour or two of relief at the end of the day. Nothing touched the pain and severe itchiness except cetirizine  one. Topical and oral Benadryl did not work, topical creams and gels did not work to stop the reaction. Daily cetirizine did the trick, my allergist had me try and go off it for two weeks for a skin prick test and I was unable. Two days off the cetirizine and my body was itching with a vengeance.  It?s been about 9 months and I have not missed more than one day without cetirizine I?d I do my quality of life is greatly reduced. I have a myriad of photos of the hives and red marks left behind from just touching or scratching my skin while off medicine cetirizine .
Within 3 h of injection, client noted "terrible rash", "itchy, red" approx 10 cm around at site of inj. Had "anxiety attack" on noticing rash. No Rx at ER visit. MD "go home, take med for anxiety and that she not get a third GARDASIL. She first said she had not (anxiety) meds but then stated she took "a XANAX". She also used an "itch cream" on the rash. Rash and anxiety resolved. She reports not having had a reaction to the first GARDASIL.
IDIOPATHIC THROMBOCYTOPENIC PURPURA; This spontaneous report received from a company representative concerned a 60 year old  female. Initial information was processed with additional information received from the patient's physician, in response to telephone follow-up, on 26-APR-2021.  The patient's weight and weight were not reported. The patient's concurrent conditions included hypertension, hyperlipidemia, and obesity. She was a non-smoker and had no history of acute illness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included blood pressure medication, vitamins, and a statin (all unspecified). On 21-APR-2021, the patient experienced Idiopathic thrombocytopenic purpura and was in critical condition. The patient presented with petechiae on her legs. Her platelet count was low, less than 9000 and all other labs were normal. The patient was hospitalized on 21-APR-2021 and the duration of hospitalization was not reported. The patient did not have any clots and she was treated with decadron and Intravenous immunoglobulin. On 22-APR-2021, the patient's and improved the next day with platelet of 30,000 and she was discharged same day. on an unspecified date anti-PF 4 antibodies were performed and were normal. Fibrin D-dimer tests were not performed. The reporter stated the discharge diagnosis was Idiopathic thrombocytopenic purpura which could have been related to recent vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from  Idiopathic thrombocytopenic purpura. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0:  This 60-year-old female was hospitalized for immune thrombocytopenia 25 days after receiving the Janssen Covid-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection.  Concurrent conditions included hypertension, hyperlipidemia, and obesity. She was a non-smoker and had no history of acute illness.  Concomitant medications included unspecified blood pressure medication, a statin, and vitamins.  Twenty-five days post-vaccination, she developed petechiae on her legs and was found to have a platelet count of 9000; all other labs were normal including anti-platelet factor 4. She did not have clots. She was admitted to the hospital the same day and was treated with dexamethasone and iv immunoglobulin. The next day, her platelet count improved to 30,000 and was discharged. Based on the available information, the relationship with Janssen Covid-19 vaccine is considered indeterminate. Additional information has been requested.
On 5/18/21 AM, woke to pain in my right side under my shoulder blade. Went to ER. They performed many blood test, chest Xray, Chest CTA. Determined Pulmonary embolism and infarction. I was admitted, more blood tests, Echocardiogram,  Venous Doppler study( No evidence of DVT). Released 5/20/21. Prescribed Eliquis to thin blood for easier natural clot dissolve. No Known cause of PE, yet.  Follow up scheduled with my PCP.
This spontaneous report was received from a pharmacist via a company representative referring to a 58-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 28-JAN-2019 the patient was vaccinated with a dose of PNEUMOVAX23, (strength, dose, frequency, route, lot # and expiration date were not reported) intramuscular for prophylaxis. And on 30-JAN-2019, the patient was vaccinated with a dose of FLUZONE in the same arm. When she administered FLUZONE, there was "a little bit of blood coming out". On 30-JAN-2019, she was experiencing "a lot of pain, redness and swelling in the arm". The patient reported her physician "recommended BENADRYL capsules, BENADRYL spray and cold compresses". On 01-FEB-2019, the patient received a prescription for antibiotic "Flucloxacillin 500 mg twice daily for 5 days". On 02-FEB-2019 (reported as "after only 1 day of antibiotics"), it was reported the patient "stopped taking the antibiotic". The outcome of a lot of pain, redness and swelling in the arm was reported as recovered on 02-FEB-2019. The outcome of a little bit of blood coming out was recovered on unknown date in 2019. The causality was not provided.
I had the Moderna booster shot on Thursday July 7th and on Saturday July 9th I started experiencing adverse side effects. They included numbing of my face, arm and leg (left side, same as where I had the shot). I had blurry vision, heart palpitation and fever, swollen lymph nodes on my neck and under arm. Near the site of the injection I had two lesions and my left arm was swollen. This lasted for several days. I saw my doctor the next Tuesday and they said my blood work looked fine and I had no infection. They said it must have been an adverse side effect from the booster. I had never had any allergic reactions to any of my previous shots which is why it was surprising.  As of the filing of this report (August 3rd, 2022), I continue to have some of the symptoms. I still have swollen, sensitive lymph nodes and numbness of parts of my face.
itchy bumps  on face, neck and hands approximately 5 hours after getting vaccine,  Pt contacted our office spoke with our triage nurse and was instructed to take Benadryl, apply cool compresses and seek emergent eval if resp. sxs developed
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 11-SEP-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # 671004/0729AA; Exp Date 17-AUG-2012) which was expired on 17-AUG-2012. Pharmacist stated that no adverse effects reported that she knew of. It was unknown if the patient sought medical attention. Additional information has been requested.
Redness and itchiness on neck, face and top of her head; Redness and itchiness on neck, face and top of her head; A spontaneous report was received from a physician's assistant concerning a 42-year-old female patient, who received Moderna's COVID-19 vaccine and experienced redness and itchiness on her neck, face and top of her head.   There was no medical history reported. Relevant concomitant medications were not provided.  On 24 Dec 2020, at 07:50, approximately three hours prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 24 Dec 2020, the patient experienced redness and itchiness on her neck, face and top of her head. After two hours, the symptoms resolved. The patient did not take any medications for the reported symptoms.  Action taken with mRNA-1273 in response to the events was not reported.   The events, redness and itchiness on her neck, face and top of her head, were considered resolved on 24 Dec 2020.; Reporter's Comments: This case concerns a 42 year old patient. The patient's medical history is not provided. The patient experienced an unexpected event of redness and itchiness on neck, face and top of her head. The event occurred on 24 Dec 2020 approximately three hours after the administration of the first dose of Moderna's COVID-19 vaccine. The reporter causality assessment for the event was not provided. Due to the temporal association between the event and administration of vaccine, a causal relationship, cannot be excluded. Additional information regarding patient's medical history and concomitant medicines details are required for further assessment.
Information has been received from a registered nurse, concerning a 25 year old female patient with a history of psychiatric disorder, who on 11-JUL-2008 was vaccinated with 0.5 mL GARDASIL intramuscularly in the left arm. Concomitant therapy included EFFEXOR, XANAX and SYNTHROID. Approximately in August, a month after receiving the first dose of GARDAIL, the patient experienced pelvic pain and joint pain. On 18-AUG-2008, the patient sought treatment for abdominal pain from an emergency room and was treated for a urinary tract infection. On 20-AUG-2008, the patient underwent a magnetic resonance imaging that indicated there was abnormal abdominal tissue. There was no product quality complaint. Additional information has been requested.
experienced side effects after taking the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (experienced side effects after taking the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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 IMMUNISATION REACTION (experienced side effects after taking the vaccine). At the time of the report, IMMUNISATION REACTION (experienced side effects after taking the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
on s-2-4-2020 - Low grade fever (100), chills, muscle aches in both legs, from top to bottom of leg. Fever last 1/2 day, chills subsided as day went on but lasted for full day. leg muscle aches until next day. fatigue for 36 hours. As of 2/25 patient is fine.
VERY SICK FOR A MONTH; INTESTINAL INFECTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced very sick for a month, and intestinal infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sick for a month, and the outcome of intestinal infection was not reported. This report was non-serious.
Swelling & pain @ injection site. Raised Redness, with white skin around the red area. Doctor is closed as it is Friday evening, have not reported side effect yet.
Pt complaining of shortness of breath and productive cough.  She has a history of diabetes mellitus.  Pt COVID positive and requiring BIPAP for respiratory support.
28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
4/22 3 pm second shot received 4/23 by noon nausea, diarrhea 101 fever, fatigue, chills, myalgia headache 4/25 all resolved but headache, new tinnitus and mild vertigo 4/27 headache, vertigo and tinnitus persist-feel like brain is swollen
8 days in bed; phlegm; runny nose; Fever; Ganglia got swelled up; Lost my voice/Lost my voice again; I am with cough. At night I cough, cough, cough; My throat hurts when I swallow/sore throat; Feel decay, without strength; Cant swallow; Feel lumps below my arm; Very sore arm after second shot; This spontaneous case was reported by a consumer and describes the occurrence of SYNOVIAL CYST (Ganglia got swelled up), APHONIA (Lost my voice/Lost my voice again), COUGH (I am with cough. At night I cough, cough, cough), OROPHARYNGEAL PAIN (My throat hurts when I swallow/sore throat) and ASTHENIA (Feel decay, without strength) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 021B221A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Sulfa). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Very sore arm after second shot). On 30-Apr-2021, the patient experienced SYNOVIAL CYST (Ganglia got swelled up), APHONIA (Lost my voice/Lost my voice again), COUGH (I am with cough. At night I cough, cough, cough), OROPHARYNGEAL PAIN (My throat hurts when I swallow/sore throat), ASTHENIA (Feel decay, without strength), DYSPHAGIA (Cant swallow) and MASS (Feel lumps below my arm). On an unknown date, the patient experienced BEDRIDDEN (8 days in bed), PRODUCTIVE COUGH (phlegm), RHINORRHOEA (runny nose) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at a dose of 1 dosage form; AZITHROMYCIN at a dose of 1 dosage form and DEXTROMETHORPHAN HYDROBROMIDE, ETHANOL, GUAIFENESIN (ROBITUSSIN [DEXTROMETHORPHAN HYDROBROMIDE;ETHANOL;GUAIFENESIN]) for Cough, at a dose of 1 dosage form. On 11-May-2021, APHONIA (Lost my voice/Lost my voice again) outcome was unknown. At the time of the report, SYNOVIAL CYST (Ganglia got swelled up), COUGH (I am with cough. At night I cough, cough, cough), OROPHARYNGEAL PAIN (My throat hurts when I swallow/sore throat), ASTHENIA (Feel decay, without strength), DYSPHAGIA (Cant swallow), MASS (Feel lumps below my arm), BEDRIDDEN (8 days in bed), PRODUCTIVE COUGH (phlegm), RHINORRHOEA (runny nose), PAIN IN EXTREMITY (Very sore arm after second shot) and PYREXIA (Fever) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Translated Follow-up document received on 14-JUL-2021 contains significant information. The treatment products were added. New events were added.
Generalized muscle and joint pain, headache, fever, nausea, chills, fatigue
Took 1 dose of oral typhoid on 06/02/03 at 7:00AM. Right arm 06/02/2005, diarrhea began aprroximately 8 times until 10:00 AM with cramping, liquid stools, Did not take any further pills.