chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 13-DEC-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R019391 with expiration date 05-JUL-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Information has been received from a health professional concerning a 5 yr old male described as a normal healthy child with no significant medical history except a speech delay, no allergies and no known or recent exposure to varicella who on 28Sep00 was vaccinated in the leg (side unk) with a first dose of varicella virus vaccine live. There was no concomitant medication. On 21Apr05 the pt presented to the office shingles on his right shoulder. The child had no other complaints. A vesicular fluid specimen was obtained from on of the child's lesions which will be submitted for PCR analysis through the VZV ID Program. At the time of the report the specimen was refrigerated in a sterile container until instructions were available as to where to send the sample. No other lab tests were done. Follow up information indicated that the pt had a rash that was zoster-like, but was otherwise well. No complications were noted. The distribution of lesions was on the right shoulder, but the number of lesion were not counted. The adequate vesicular swab specimen was collected on 21Apr05 and was received on 06May05. The results of the PCR analysis revealed that the specimen contained the wild type varicella zoster virus. Follow up information was received from the physician which indicated that the pt recovered prior to 18May05. Additional information is not expected.
Given BEXSERO 7/11/2016 #2 - no previous reaction to immunization given 6/8/2016.
mom states fever went up to 105 R & pt had sz went to hosp;has not had any sz since;
patient feels pain at injection site. her arm is warm and looks like there is redness in the arm area that has spread over the upper arm. patient has taken acetaminophen for the pain
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 10:00 as dose 4 (booster), single (Lot number: En3275) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid. No follow-up attempts are possible. No further information is expected.
Report received 2/13/00, from a physician, regarding adverse events possibly associated with Fluvirin. A 47 year old female pt received the vaccination at the end of October, 2000 and within 2 weeks, she developed severe arthritic symptoms; took ibuprofen, with relief; stopped the ibuprofen and relapsed. In mid-December, she developed ascending numbness, from feet to neckline and the sensation of "stocking/glove"; not complete loss of sensation. On 1/01/01, she noticed electrical-shocking spasms. She has been prescribed a 21 day course of Ceftin for Lyme Disease-like symptoms; is also being treated with Pamelor some compound (carisoprodol and aspirin preparation), and Motrin. The pt had received her 3rd and final dose of Lymerix vaccine in June of 2000. The reporting MD questions interaction between Lymerix and Fluvirin or the possibly that Fluvirin stimulated on autoimmune reaction to trigger Lyme-like reaction. Additional information has been requested.
Person was given Moderna vaccine on date he was due for Pfizer vaccine. No adverse reaction.
My wife had flu and tested positive for COVID-19; I did a COVID-19 test and I tested positive and keep testing positive for 2 weeks, with cough, I did a telehealth session with my doctor and gave me steroids for 10 days, basically kept the cough under control, but I still have it, it has been 10 weeks. I am no longer positive for COVID-19, but that's what happened.
chills; fever (99); headache; fatigue; This is a spontaneous case from a contactable consumer (patient herself). A 45-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number En6200) via an unspecified route of administration in left arm on 17Feb2021 at 12:45PM (at the age of 45-year-old) at single dose for COVID-19 immunisation. The patient had COVID prior to vaccination and was not tested for COVID post vaccination. Concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. During the first 24hours the patient had no effects. The day after, on 18Feb2021 at 01:00PM, the patient had chills, fever (99), headache and fatigue. The patient took an Aleve. The events were resolving.  No follow-up attempts are possible. No further information is expected.
Shortly after vaccine patient fainted. Came to within minutes, light headed. Rescue came, low BP. Took patient to hospital per patient request
The spontaneous case, was initially received on 17-Oct-2017 reported by other non-health professional, concerning a 18-year-old, adult female patient. On 16-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195212, expiry date: 31-Mar-2018). On the same day, immediately after vaccination, the patient experienced nausea and weakness. The patient went to ER (emergency room) and was treated with IV fluids and unspecified shot. The patient stated that, the reaction was due formaldehyde in the flu vaccine. The outcome of the events was not reported. The reporter assessed this case as non-serious. Significant follow-up received on 30-Oct-2017: The age of the patient was confirmed as 18. The treatment included IV fluids and unspecified shot. Narrative was amended accordingly. Significant case correction received 17-Oct-2017: The listedness of the event nausea was corrected to listed from unlisted.
A consumer report has been received. The report concerns a 6 year old, Female consumer who had been received nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 23-Sep-2014. The patient experienced TESTED POSITIVED FOR INFLUENZA which started on 01-Dec-2014. The patient received from the event of TESTED POSITIVE FOR INFLUENZA on an unspecified date. The report was considered to be non-serious.
I had a mild cough that turned more serious yesterday morning. I also have a sore throat and general body ache. I took a COVID-19  rapid antigen test that turned positive. I was prescribed PAXLOVID by my doctor.
Presented with weakness, fever, SOB, productive cough; + Covid ED; Admitted  to medical with Covid PNA; tx with maxipime, steroids, remdesivir, zithromax, rocephin, singulair, zinc, minimal O2 supplement;
Went to urgent care 4 days after first vaccination for back pain. Thought to be a kidney stone or pulled muscle and sent home. Died at home two days later on 8/24/21.
Red circle of 5 cm; This spontaneous case, initially received from other health professional (nurse) on 05-Oct-2018, concerning a female patient of unspecified age.  On 04-Oct-2018, the patient was administered Afluria Quadrivalent vaccine [influenza vaccine, dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 01344611A (reported as 03144611A) and expiry date: 30-Jun-2019] for active immunization against influenza.  On the same day, 6 hours after vaccination, the patient developed a red circle of 5 cm in area.   At the time of this report, the patient had not recovered from the event (redness).  The reporter assessed the case as non-serious.  This case was linked to 201804327 due to same reporter.  Update received on 02-Nov-2018: Non-significant case correction (IRD: 05-Oct-2018)- The area of red circle in the narrative was changed from 5 m to 5 cm and amended accordingly.; Reporter's Comments: A female patient of unspecified age developed erythema, 6 hours after vaccination with Afluria Quadrivalent vaccine. The company assessed the causality of the event as related to the suspect vaccine, due to plausible temporal relationship between the event and suspect vaccine.
Tinnitus in both ears; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 08Jun2021 at 10:00 as a single dose for COVID-19 immunisation. Medical history included hypertension, thyroid cancer and penicillin allergy. Concomitant medications included levothyroxine sodium (SYNTHROID), hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ) and vitamin d nos (VITAMIN D), all for unknown indication and from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the right arm on 29Apr2021 at 10:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 12Jun2021, the patient experienced tinnitus in both ears. The patient underwent ENT and GP exam and no treatment was received. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event tinnitus in both ears was not recovered at the time of this report.
36 hours after shot patient awoke very stiff with severe joint pain.  The pain started with major joints and traveled to minor joints.  Pain prevented typing and made stairs very difficult.  Final joint pain subsided in fingers on 24 Dec 03, 11 days after shot.
Bump appeared left thigh morning after vaccines. Two days later bump had resolved, no redness but still had some swelling. As of 8/23/15 redness had come back. No other symptoms, does not bother patient.
I developed lymphedema after the 2nd dose of the vaccine. I developed swelling in both my feet and ankles. I was not able to put shoes on due to swelling. I started to wear compression socks which helped but the swelling persisted. So I went to see a doctor who indicated that it was not normal swelling, it was lymphedema. I was able to see a Lymphedema Therapist who referred me to certified therapist. I saw the doctors there and he confirmed that it was lymphedema and referred me to a certified lymphedema. I went all last summer and was treated with wrap therapy in July and August. I also had massage therapy and the swelling went down. It did not go away all the way, I am still wearing compression socks and have not completely recovered. I initially did not think it was related but after having my mammogram and seeing the questionnaire, I was able to make the connection to what I was experiencing.
He believes all 4 shots were full dose; This spontaneous case was reported by a patient and describes the occurrence of OVERDOSE (He believes all 4 shots were full dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 049C21A, 023M20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included RITUXIMAB (RITUXAN) for Rheumatoid arthritis.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OVERDOSE (He believes all 4 shots were full dose). At the time of the report, OVERDOSE (He believes all 4 shots were full dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jul-2022, SARS-CoV-2 antibody test: SARS COV 2 antibody was zero.   It was reported patient has been on Rheumatory Arthritis Rituxan infusion for some years at time of reporting. Patient had stopped the infusion of Rituxan after last COVID shot on 24-Jan-2022. Patient did not had COVID. Patient stated that  was told verbally that he does not have enough Protein. Treatment details were not reported by the reporter.
Pneumovax given left deltoid and blood work also drawn on left anticibital. 9/6/02 patient seen left upper arm redness, swelling and no temp. Local infection before blood work or allergic reaction to vaccine?
The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.; No adverse event; Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event) in an adult 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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, 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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.).    No concomitant medication was reported.   Suspect product dosage text was reported as unknown. The vial did not undergo any temperature excursions. Suspect vaccine expiry date was 11-May-2023.  It was reported that no adverse reactions have been reported by any patients.  No treatment medication was reported.  This case is reported for patient 40th out of 50 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Patient 1 out of 50 (Lot AS7143C was administered on 5Jun2023)
Patient started to act lethargic and would not eat. He was crying and inconsolable. We finally got him to bed only to be woken at 12:30 AM to him vomiting stomach bile and lucent. He was non-responsive and had to be taken by ambulance to the ER. They administered IV fluids and his white blood count was very high so we had to keep him there for several hours until he started to be more receptive to our communication. He is autistic and non-verbal so he could not explain what was going on. Patient is still having persistent diarrhea that we have tried for months to treat that started with this event.
I started feeling sever flu; aches; I am nauseated; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (I started feeling sever flu), PAIN (aches), NAUSEA (I am nauseated) and ARTHRALGIA (joint pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced INFLUENZA (I started feeling sever flu), PAIN (aches), NAUSEA (I am nauseated) and ARTHRALGIA (joint pain). At the time of the report, INFLUENZA (I started feeling sever flu), PAIN (aches), NAUSEA (I am nauseated) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
12/23/21  at 11:30pm patient began to complain he didn?t feel right and was ?shaking?. His entire body began twitching every few seconds. Patient begged for something to make it stop. The entire body twitching lasted for about 90 minutes and stopped without intervention or medication.  1/11/22 at 9:00pm patient began to complain he felt weird and was ?shaky?. Mom felt his body and found right leg to be tremoring and twitching. It was only present in right leg from just below hip to the toes. Patients mom took a video of the twitching. Twitching lasted about 60minutes.
Unconsolable crying since Daptacel vaccine on 12/02/2003 to date of office visit 12/04/2003.
Headache, Myalgia, NauseaVomiting, The employee reports that she received the first dose of the vaccine on 01/04/2021. She started to experience "pounding headaches" 3 days ago (1/12),  worsened for two days, especially when standing up, and slight nausea/vomiting with  no emesis. She is als The employee reports that she received the first dose of the vaccine on 01/04/2021. She started to experience "pounding headaches" 3 days ago (1/12), worsened for two days, especially when standing up, and slight nausea/vomiting with no emesis. She is also having difficulty sleeping for the last two nights d/t headaches and sensitivity to light. She has been drinking sufficient fluids.  Monitoring her blood pressure at home as she has a history of low blood pressure and readings are WNL. Tylenol and Ibuprofen are ineffective; a low dose of Dayquil is helpful. Headaches improved today. She is advised to continue hydrating, may use ginger or lemon-lime flavored beverages to help with nausea. Consumer a balanced diet; rest/relax when needed. Changed position slowly to avoid worsening the symptoms. Seek medical help if symptoms are worsening or having difficulty with breathing.
Patient was administered vaccine and appeared fine immediately after, even got up and walk for a second.  He then sat down (all in a matter of 1 minute)  after about 2 mins of sitting in the chair he fell to the floor.  He cut his head and also bled from his nose.  He became conscious again quickly in less than about 1 minute.  He was then aware of where he was, date and his name.  EMS responded and took over.
Woke up with a swollen and stiff arm for 4 days after receiving the flu vaccine
Patient was administered a ProQuad (MMR/Varicella) vaccine IM (intramuscular) in the left arm, when it should have been given SC. A second dose of Proquad given in Left arm subcutaneously. Parent notified of the incident. Child monitored, appears in no distress. Parents given information about what to expect after the shots, VIS given, and "after the Shots sheet" with information about what to expect after the shots. Phone number of clinic provided to patients to call if any questions.
Severe headaches  - started that night; next morning it was still there with severe vomiting and nausea. This time it felt like I had the flu - I was really fatigued and weak and no energy. These symptoms all  lasted about 30 hours. Treated with Tylenol but that did not help. No doctor appt or testing.  I have been still having headaches. Since my second vaccine they have been constant  - don't go fully away- some days are worse than others.
1/12/21 VACCINATION.   1/19/21 INJECTION SITE "ITCHY."   1/20/21  ITCHY,RED, RAISED, WELL DEFINED, INDURATED AREA APPROXIMATELY  3" X 1.5"  ABOUT 10 MM  FROM INJECTION SITE
Cellulitis of the arm. Warm to the touch and doubling in size every few hours. Being treated with antibiotics.