chrisvoncsefalvay/vaers-outcomes huggingface dataset:
started to feel unwell; I also experienced lethargy; I experienced arm soreness that increased throughout the next day; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (started to feel unwell), LETHARGY (I also experienced lethargy) and MYALGIA (I experienced arm soreness that increased throughout the next day) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy, Allergy to molds (Mold and mildew) and Dust allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRETIC), SODIUM CHLORIDE (SALINASE [SODIUM CHLORIDE]), EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA), ASCORBIC ACID (VIT C), VIT D [VITAMIN D NOS] and ZINC for an unknown indication.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (started to feel unwell), LETHARGY (I also experienced lethargy) and MYALGIA (I experienced arm soreness that increased throughout the next day). At the time of the report, MALAISE (started to feel unwell), LETHARGY (I also experienced lethargy) and MYALGIA (I experienced arm soreness that increased throughout the next day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jul-2021, SARS-CoV-2 test: positive (Positive) positive for COVID-19.         Other Concomitant medication include Truevita and Barley green for an unknown indication..  No treatment medications were provided.   This case was linked to MOD-2021-253075 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up report contains Patient demographics ,concomitant medication, facility information and new event were added .
Client received Hepatitis A vaccine #1 on 7/22/22. Client received dose #2 on 8/5/22. The second dose was administered too early. There was no reaction to the vaccine. Client was informed of the error.
Headache, Sedation, Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, Dizziness, Hot/Cold extremities, Pain @ injection site Narrative:
Diarrhea. had been ill on 03/05/2010 with flu-like symptoms of diarrhea, some vomiting-but no fever. All family had had stomach flu, but started getting better - mother called Dr took immunizations and was given 03/08/2010 - Had started diarrhea again shortly after and had not let up - no vomiting - no elevated temp. Stools are smelly and explosive. has been to clinic and stool samples are being taken. testing for Salmonella, Shigella, bacterial pathogens, E. coli, Vibrio, Yersinia, Camphobac, ova parasites. Infant is on Similac Advance (powdered) et rural water is used. Mother reports some stools are all water and others are soft liquid. Called clinic and nurse will ask physician about testing for Rotavirus.
Information has been received from a registered nurse concerning a 19 year old female patient with a history of cholecystectomy (FEBRUARY 2005) and no allergies who on 06-AUG-2007, was vaccinated IM with a first 0.5ml dose of Gardasil (Lot # 658282/0929U). Concomitant therapy included ethinyl estradiol/norethidrone (OVCON). About 2 hours after receiving the vaccine, the patient experienced severe abdominal pain, nausea, vomiting and diarrhea. The patient stated that the area that hurts was about 2 inches from her belly button. The patient was prescribed atropine sulfate (+) diphenoxylate hydrochloride (LOMOTRIL) and promethazine hydrochloride (PHENERGAN). It was reported that the next day the patient called the office and her stomach pain had gotten worse. On a scale of 1 to 10 the patient felt her pain was a six. Laboratory diagnostic studies given on 07-AUG-2007 included a CBC and a thyroid study. Both were reported as normal. The patient no longer has diarrhea but was still experiencing nausea and vomiting. The outcome of severe abdominal pain was unknown. No product quality complaint was involved. Severe abdominal pain, nausea, vomiting and diarrhea were considered to be disabling. Additional information has been requested.
mom stated pt jerking, vomiting;advised to see PMD ASAP;mom will call 911;pt exp sz & t104;
Per OSDH: Regarding Health on the following COVID Vaccine Moderna. Please see the following determination; Doses Administered from 4.6.2021 to 5.21.2021:Based on the information you have provided and the lack of temperature data, we are not able to conduct an analysis or guarantee the doses administered between 4/6/2021 and 5/21/2021 provided the necessary protection against a COVID-19 infection. Please continue with the original plan of action on revaccination and completing a VAERS Reports on the all clients you have identified.
Information has been received from a registered nurse, concerning "other patients" (gender and ages not reported), who were vaccinated with a dose of GARDASIL (dates and lot # not reported). After the vaccination, the patients became dizzy. The nurse added this appears to happen when the patient's who have not eaten breakfast are vaccinated in the morning. SHe added that they now ask the patients if they have eaten breakfast and "pay close attention" when they're being vaccinated, to observe for dizziness. At the time of this report, the outcome of the event was unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. On unspecified dates, an unknown number of patients had been inadvertently administered (Oka/Merck) VARIVAX (dose, route, lot # and expired date were not reported) and ZOSTAVAX, vial, (dose, route, lot # and expired date were not reported), that had been improperly stored. Concomitant therapy was not reported. No adverse effects reported. Follow up information received from pharmacy manger on 11-SEP-2014. The reporter stated that the (Oka/Merck) VARIVAX that had the temperature issue was not used on a patient. However, one dose of the ZOSTAVAX vial, (dose, route, lot # and expired date were not reported) was administered to a patient yesterday (approximately on 10-SEP-2014). No adverse experiences were reported. Additional information has been requested.
On 07/12/02, received Varivax, 13 days later, he developed high fever and generalized pox rash over his entire body. (The child) was very cranky. In 4-5 days, he improved and skin lesions dried up. (The child's)  twin had same reaction but less severe.
Information had been received on 21-NOV-2106 from a nurse regarding a 70 year old female patient with allergy to cephalosporins who received a dose of PNEUMOVAX23 "in August 2016" at her allergist's office. Concomitant medications included LIPITOR, FLONASE, an unspecified thiazide, CLARITIN and PROTONIX. On an unknown date, patient consulted physician because she developed a rash on her legs bilaterally after receiving PNEUMOVAX23. The nurse didn't have any details about the dose of PNEUMOVAX23 that was administered. On an unknown date, the physician did a biopsy of the lesions and believed that the lesions are possibly lichens planus or "bites". The physician documented that the patient's legs are "better" on 11-NOV-2016. Patient's present status was recovering. Patient received unspecified treatment for her adverse event. The nurse was not able to provide many details about this adverse experience because she said, "I just called to ask a quick question". No additional information was provided.  Additional information has been requested.
Bells Palsy; Numbness in left side of face; A spontaneous report was received from a consumer who was also a 43 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced Bell's Palsy / facial paralysis and numbness in left side of face / hypoaesthesia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Feb 2021 at 3:15 pm, approximately 25 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly in the upper left arm for prophylaxis of COVID-19 infection.   On 17 Feb 2021, about 25 minutes after receiving the vaccination administration, the patient reported numbness on the left side of his face. His doctor informed him that he had Bell's Palsy and to take diphenhydramine. Consent to follow up from safety was provided by the patient.  Action taken with the first dose of mRNA-1273 vaccine was not reported.  The events, Bell's Palsy and numbness in left side of face, were ongoing at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
This spontaneous case reported by a pharmacist, describes the occurrence of postmenopausal hemorrhage (report of spotting post vaccination) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced postmenopausal hemorrhage (report of spotting post vaccination). At the time of the report, postmenopausal hemorrhage (report of spotting post vaccination) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Patient was post menopausal and reported spotting post vaccination. Sender's comments: Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.
Painful R leg, did not want to walk on leg.  Developed swelling w/red raised rash after pain subsided at injection site.
Patient received vaccination around 12:10-12:56. RN saw EMS arriving to get patient at 12:56.  Patient stated about 5-10 minutes after getting the vaccination she felt numbness and tingling of tongue. Wanted to go to ED to be examined. Stable at time of departure with no visible edema.  Airway intact.   Patient did go to the ED, and was triaged. Left without being seen.
Bell's Palsy. Right facial paralysis, right eye won't close fully. Blurry vision and teary right eye. Headache. Symptoms started within 36 hours. Now in day #5. No change in symptoms
Left leg swelling, limping, increased warmth. Tx supportive like compress/elevation/NS.
Headache started 24 hours after first shot and has not gone away. Headache does not respond to any traditional treatments, either prescription or OTC. The only time headache isn't present is when sleeping
Approximately 7 to 10 days after receiving the vaccine, the patient experienced a temperature of 104F, cough, cold, chills, and aches.
Hives developed starting on 12/20 and lasting through today.  They would appear all over my body, dissipate, then reappear. Benadryl alleviated symptoms temporarily. Zyrtec has been more effective, but they have continued to reappear. They've lessened in severity, however.
Started as discomfort in lower back/ lumbar area. Tried chiropractor no help over about 10 weeks. Had lumbar MRI with Neurosurgeon.  Required MRI in cervical and thoracic areas of spine. Surgery in October 2021 in cervical area. Had 3 epidurals to treat soreness in lumbar, no help.  Referred to neurologist in March, performed EMG. Determined I have peripheral neuropathy in left leg. Starting PT March 21,2022 to hopefully correct inability to walk steady, maintain balance and strengthen all muscles.
Initial pregnancy report received from a non-healthcare professional (patient) on 18 September 2013. A 32-year-old female patient, whose medical history and concomitant medications were not reported, had received intradermal first dose of FLUZONE ID vaccine (anatomical site of administration was not reported) on 18 September 2013. The patient's last menstrual period was not reported and the expected date of delivery is 02 April 2014. The patient did not experience any adverse event and stated that pregnancy will be normal to date. List of documents held by the sender: none. Follow-up received on 10 January 2014. It was reported that the patient did not receive the vaccine in reporter office. Hence, consider end of follow-up.
Information has been received from a physician who heard from a nurse that a male patient with rheumatoid arthritis, who on an unspecified date, was vaccinated with the first dose of GARDASIL (lot # not reported). Shortly after receiving the first dose, the patient experienced 9 months of exacerbated rheumatoid arthritis symptoms. The patient's mother had decided to not complete the GARDASIL series. After 9 months, the patient recovered from exacerbated rheumatoid arthritis symptoms. It was unspecified if the patient sought medical attention. Attempts are being made to verify the existence of an identifiable source. Additional information has been requested.
Pain in left knee making it difficult to walk upon getting out of bed.; Pain in left knee making it difficult to walk upon getting out of bed.; This is a spontaneous report from a contactable consumer (Patient). A 76-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9810 and Expiry date: Unknown), via an unspecified route of administration, administered in Arm Left on 06Feb2021 13:00 (at the age of 76-years-old) as DOSE 1, SINGLE for Covid-19 immunization. Not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication(s) included lecithin, hormone replacement, CA, D, levothyroxine. Patient had no allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any treatment and diagnosed with Covid 19 and has not been tested for COVID-19 Since the vaccination. On an unspecified date the patient experienced pain in left knee making it difficult to walk upon getting out of bed. I had no previous problems with my knee. Patient did not received any treatment for the events. The most recent COVID-19 vaccine was administered at hospital. Non-serious report. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Incorrect dosage administration; Pediatric dosage received instead of recommended adult dosage per patient age
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage than recommended. Patient presented nausea,vomiting, fever and pain at injection site and chest pain.
had a bad reaction and it went on for 3 weeks; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a bad reaction and it went on for 3 weeks) and PAIN IN EXTREMITY (Sore arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 012M20A and 011L210A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced VACCINATION COMPLICATION (had a bad reaction and it went on for 3 weeks) and PAIN IN EXTREMITY (Sore arm). On 18-Oct-2021, VACCINATION COMPLICATION (had a bad reaction and it went on for 3 weeks) and PAIN IN EXTREMITY (Sore arm) had resolved.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2022-538193 (Patient Link).
Patient states: "The next day I was in bed feeling like I was having a heart attack. My chest hurt. I was sweating and really feeling bad."  "I did not let anyone know.  By day two, I felt fatigued and with muscle soreness all over, but was feeling better by Day 3."  I did not go to the doctor or the ED.  I told my own doctor about it a while back ago (long after the experience) and he said it might have been myocarditis. "
90 minutes after receiving vaccine client experienced headache.  She took ibuprofen but didn't receive any relief until second dose taken 4 hours later.  Symptoms progressed to fever of 102 degrees F, stomache and general malaise. Took additional ibuprofen this morning at 8:00 am. At 9:30 am temperature is currently 99.8 degreees F.  General malaise continues. Has private physician.  Advised to consult with him and monitor for progression or worsening of symptoms. Mother is declining further doses of vaccine for daughter.
Full body hypersensitivity rash with oral involvement, starting 3 days after vaccination.
chest pain; left side; heart pain  after 24 hours. contacted the doctor for more information.
01/16/2022 As soon as a I woke up I had a sore throat, sneezing and body aches. I went to urgent care and they tested for COVID. On 01/17/2022 results came back positive for COVID. They advised once I start to get better I could go back to work. When I would be asleep I would feel cold chills, but when I wake I would be very hot. My temps got up to 99.5. I also experience insomnia and high blood pressure 143/92. The insomnia has gone away since being prescribed Seroquel. I did take low aspirin and it helped with the body aches. I was out of work for a full week and when back to work the following Monday. I was feeling better but on 02/01/2022 I woke up with a severe sore throat and body ache. I went to urgent care and my tonsils swollen. He tested for strep and that came back negative. They prescribed methylprednisolone 4mg 6-day pack. It caused me to experience mania. People around me were starting to tell me I was not acting normal. I was posting things on social media I would not normally do. I was calling people and confessing my sins. I do remember them happening, but it feels fuzzy and I don't know why I felt compelled to do those things. I went to the doctor and they told me mania usually lasts 3 weeks, but in my case they are telling me this is permanent. They had me do a written psych test and I tested almost 100% for Bipolar. The after visit summary result indicated mood disorder and mania events.
1st dose from Pfizer vaccine 2nd dose from Moderna vaccine; became sick for two days; fever; headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1st dose from Pfizer vaccine 2nd dose from Moderna vaccine), ILLNESS (became sick for two days), PYREXIA (fever), HEADACHE (headache) and MYALGIA (body aches) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19.    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 and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st dose from Pfizer vaccine 2nd dose from Moderna vaccine), ILLNESS (became sick for two days), PYREXIA (fever), HEADACHE (headache) and MYALGIA (body aches). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (1st dose from Pfizer vaccine 2nd dose from Moderna vaccine) and ILLNESS (became sick for two days) outcome was unknown and PYREXIA (fever), HEADACHE (headache) and MYALGIA (body aches) had resolved. Not applicable          No relevant concomitant medications were reported. No treatment details were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-060652 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received on 15 Jun 2021 included information on: Additional adverse event details and its outcome; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060652:Same reporter (MOD21-064563)
Diarrhea; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist) from a sales representative. The reporter is the patient.  A male patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea".  Additional information: Event took place after the use of vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nausea, Cold fever, upset stomach, no appetite, pain, headache, vomiting, sore arm
Had covid/tested positive; Had covid/tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 21K-163-4078537-00.  A male patient received bnt162b2 (BNT162B2), intramuscular, administration date 02Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Sep2021, outcome "recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Had covid/tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken for adalimumab was unknown.  Clinical Course: Reported as, Reporter and her husband both had covid with coughing, aches and pains. They tested positive before the second dose.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Fever 103.4 Headache Backache Sore, swollen arm at injection site Left supraclavicular lymph nodes hard , swollen, and sore
10 x 10 cm very red sl raised plaque (R) upper arm centered over MMR site. No pain, heat, swelling, itching.
Headache (increasing in severity over next 2 days), swelling of injection site, redness around injection site, fever, vomiting, lethargic. Lasted for 3 days.
erythema, swelling @ site, pain, ax adenopathy, onset 24 hr; treated w/ATB-resolved quickly