chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Over the following 7 months after 2nd covid vaccine, my menstrual cycle increased to heavier bleeding and longer duration, resulting in me having anemia and lifestyle interruptions due to severe bleeding and exhaustion.  Menstual cycle continued to increase, lasting  up to 25 days.
Redness 5 in x 4 in area, warm to touch, arm can be moved, area is just sore.
Client received the COVID vaccine Janssen Lot#205A21A at 1:29 PM. RN was alerted by the client's family prior to vaccination that the client has a history of "fainting" with injections. RN recommended vaccination on the cot in the observation area to decrease risk of syncope. The client and his parents refused vaccination in the observation area and his mother stated "if he can look at his phone he'll be fine." The client received the vaccination at the table and ambulated to the observation area. RN was alerted by the client's parents at 1:39 and responded. EMT also responded at this time. The client was not verbally responsive to RN and EMT and his posture was tense sitting in the chair. RN elevated the client's legs on a metal chair. The client's posture relaxed and subsequently the client regained responsiveness. No injury was sustained. The client then stated that he was dizzy and lightheaded. He denied SOB, throat tightening, and itching. . Client was AOx4. Vitals obtained by EMT were as follows: BP 132/88 and HR 64 regular rate and rhythm. RN noted pallor on the client's face. At 1:42PM the client stated he was "a little bit dizzy" denied any other s/s of an allergic reaction. The client was offered water and began drinking it. No medications administered. Client denied any chronic conditions or medications and no known allergies. He began eating some goldfish at 1:45 PM. RN provided education to client and his parents regarding s/s of anaphylaxis, when to seek EMS, to follow up with PCP regarding syncope event, and V-safe. The client and his parents voiced understanding of this. Vitals obtained by EMT at 1:50 were BP 122/90, HR 72, RR 20. Repeat vitals obtained at 2:00PM were BP 122/86, HR 64, and RR 16. The client departed the vaccination site at 2:05 with his parents unassisted with a steady gait. The client's parents drove him home.
Patient received the above vaccines without difficulty and was able to pick out his stickers afterwards. Patient walked out the office with mother and mother's friend talking about plans for after leaving the office. About 5-10 minutes later, the nurse was called to the front hallway where the patient was laying in his mother's lap sitting on the floor. Patient looked drowsy and was not talking. Nurse felt the boy and skin was warm to touch. The nurse removed his jacket and began cooling him down. Mother states the child began coughing and said he was feeling dizzy when seconds later he was not able to walk straight where he then collapsed into his mother's arms. Water was brought to him and he was able to sit up and drink without difficulties. Nurse felt pulse and heart rate, within normal limits. Child was able to answer questions from nurse and mother appropriately. After the child had a few sips of water the nurse asked the child to walk without assistance to the nearest door and back. The child was able to ambulate without assistance. The patient, mother, and mother's friend was then escorted to the lobby to remain for observation. Roughly 5- 10 minutes later the child was reassessed by the nurse. Mother was instructed to monitor him closely for the remainder of the day and the days to follow and if child's symptoms worsen or do not improve, notify pediatrician and/or Emergency Room. Mother verbalizes understanding and states they are ready to go home. Child was asked by mother if he wanted to walk or be carried, and child shook head and motioned towards mother to be carried.
Excessive phlegm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (Excessive phlegm) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PRODUCTIVE COUGH (Excessive phlegm). At the time of the report, PRODUCTIVE COUGH (Excessive phlegm) had not resolved.            No concomitant medication was reported. No treatment medication was reported.  The reporter's causality for the event of excessive phlegm was not provided for Humira.  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.
Initial report was received from a healthcare professional on 12 January 2012. A 5-year-old male patient had received an Intramuscular (IM) injection of DAPTACEL; lot number C3514AA, FLUZONE; lot number UH498AA and IPOL; lot number E0950 in left and right thigh on 10 January 2012. On the same day of the injection, the patient developed "high fever" to Fahrenheit (F) which lasted into the next day. However, the patient had history of high fever with earlier infant immunization which took time to get back to normal. On 12 January 2012, the patient started acting differently than normal; more rambunctious and impulsive, like a "hyper child". No further informational was available at the time of this report. The outcome was reported as not recovered/not resolved. Documents held by sender: none.
Patient was given Covid vaccine 28 days after the beyond use date. Patient reports no side effects to vaccine administration. Pfizer has been notified. Patient has been notified.
Pt. rec'd 15 mo immunizations at 4-14-15 WCE in office. Developed redness, edema and warmth to (Lt) thigh that evening. Seen in office for s/s on 04/15/15 and Dx with adverse rxn to DTaP. Tx with ice, ibuprofen-return PRN.
This male patient of unspecified age, reported as 33, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient stated that on his both hands he had a reaction after getting the first dose of the vaccine. He stated that he had something like a chemical burn underneath his skin; his hands turned pink with painful sores, had brown spots around hand and his skin peeled off. He reported that "now" it is bright pink, and skin fell off, further reporting he had one line that was dark that hurt and he thought that it was a muscle. The clinical outcomes of something like a chemical burn underneath his skin, his hands turned pink with painful sores/brown spots around hand/ it was bright pink/one line that was dark, one line that was dark that hurts and he thought that it was a muscle, and skin peeled off were unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
she got a headache; flu-ish like symptoms; she had a slightly elevated temperature; She states she felt extremely tired and felt like she had a bug; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 04Nov2021 as dose 2, single (Lot number: FF2593) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Caller states she has a history of asthma since a child.; "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: XYZAL taken for seasonal allergy; TUMS [CALCIUM CARBONATE]. Vaccination history included: BNT162b2 (1st dose Pfizer COVID-19 Vaccine:, Lot number: 104F83592, Route of Admin: left arm), administration date: 14Oct2021, when the patient was 42-year-old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset Nov2021, outcome "recovering", described as "She states she felt extremely tired and felt like she had a bug"; INFLUENZA LIKE ILLNESS (non-serious) with onset Nov2021, outcome "recovering", described as "flu-ish like symptoms"; HEADACHE (non-serious) with onset Nov2021, outcome "recovering", described as "she got a headache"; BODY TEMPERATURE INCREASED (non-serious) with onset Nov2021, outcome "recovering", described as "she had a slightly elevated temperature". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient height was 175 cm and weight was 106.59 kg. Caller stated that she had a history of asthma since a child. She stated that she sees an Allergist once a year and had rescue inhaler. She stated that she had not used the rescue inhaler since last August or September when high pollen and plants die off. She stated that she was the age of 10,11, or 12-years-old when she was diagnosed. No investigations. No prior vaccinations within 4 weeks. No family history relevant to Adverse events. She had no concerns. Stated that she was the only one in her immediate family who has gotten the vaccines. The patient had other conditions and other products. Reporter stated that she called about the Pfizer COVID-19 Vaccine. Reporter stated after her 2nd dose of the COVID-19 vaccine within the 1st 16 hours she got a headache and a fluish like symptoms. She had a slightly elevated temperature but was a low temperature and this took 36-48 hours to feel better. She states she felt extremely tired and felt like she had a bug. Relevant test: none.
Patient is a 74 y.o. male with a personal history of end-stage renal disease, COVID-19 diagnosed on 01/25/2022 with mild disease course, CVD, CAD bladder cancer with urostomy, hypertension, COPD, OSA, PAD, calciphylaxis, chronic back pain on opiates presents from home after discharge 3 days ago with ongoing weakness.  He was evaluated in the Clinic for consideration of intervention for PAD of the right lower extremity in the setting of wet gangrene/ calciphylaxis on 02/01/2022.  He was hypotensive at clinic appointment.  It was recommended he be admitted to the hospital at that time.  He received PT/OT and had adjustments to his antihypertensives.  He cleared PT/OT and was discharged to home.  He lives in a mobile home.  His daughter with special needs and another daughter live with him in the mobile home as it stands.  His appetite is actually improved.  Unfortunately, patient states he is still worsening global weakness.  Family has been doing wound cares to the right lower extremity.  They unfortunately, did not feel it can assist.  Patient states he has significant pain to his lower back and the right lower extremity.  Right lower extremity limits ambulation.  He unfortunately also missed his dialysis session this morning.  COVID positive 01/25.
Within 20 to 30 minutes of vaccination the vaccine site started itching and then my whole left arm was itchy.There was also a diffuse erythematous rash on my upper left deltoid and tricep. No hives, difficulty breathing, edema, or throat tightness were present. The diffuse rash subsided after a day or two but there is still a small circle of erythema directly around the injection site and the area is slightly indurated and my upper arm is still itchy. I am not overly concerned about the side effects but thought it weird that it is still itchy and indurated but thought I would report it so these side effects can be included in any data collection. Thank you.
This case was reported from a pharmacist via call center representative and described the occurrence of feels awful in a female patient who received FLULAVAL QUADRIVALENT (batch number 93T79, expiry date June 2016). Concurrent medical conditions included rheumatoid arthritis. In 2015, the patient received FLULAVAL QUADRIVALENT .5 ml. On an unknown date, 10 hrs after receiving FLULAVAL QUADRIVALENT, the patient experienced feels awful and excess sweating. On an unknown date, the outcome of the feels awful was not recovered/not resolved and the outcome of the excess sweating was unknown. The reporter considered the feels awful and excess sweating to be possibly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The healthcare professional reported that one of her patients was administered FLULAVAL QIV. The healthcare professional stated that the patient was feeling yucky and sweating profusely. The healthcare professional did not have date of birth of the patient.
I felt warm, flushed, and dizzy. I had tingling in my fingers, arms, and elbows. I had dry mouth and nasal stuffiness.  The injection site was sore and the soreness extended from the injection site down my right arm.
Expired vaccine administered to 8 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 8 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 8 patients). On 16-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 8 patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that the vial was kept under Moderna recommended temperature range the entire time. There was nothing else wrong except that the vaccine was administered beyond the manufacturer's expiration date . No treatment medication was reported.
03/04/21 No symptoms until 9:15 a.m. (approximately 30 mins after vaccination), began feeling faint, weak, rapid pulse, heart skipping, numbness and tingling in fingers and toes, ringing and heat in ears, rash/redness on chest, neck and ears, intermittently "seeing stars", extremely dry mouth, hoarseness in voice and dry cough when speaking. Made my way to my sister's dental office nearby, where approximately 1 hour later, she gave me 50 mg of Benadryl and 99% Oxygen 2L/min via nasal cannula.  BP 131/82, pulse 81, blood sugar 126 ml/dl.  When not resolved after approximately 1.5 hours,  I proceeded to the hospital Emergency Room.  They did an EKG (normal), gave me famotidine and a steroid and observed me for a couple of hours.  Most symptoms had subsided and was released at approximately 2:30 or 3:00 p.m.
she waited 15 minutes then drove home. en route she experienced trouble breathing and dizziness. she pulled over and called the facitily. she was close to another fascility so I told her to call 911 and go to the facility to see about getting an epi pen. ems arrived and said she was dehydrated and had low blood sugar. they took her to the hospital
Pt c/o arm pain, redness & swelling at site of ZOSTAVAX injection. Pain at time of injection. Redness started 24 hrs later. 10x10 area of redness, warmth, & induration lateral Rt upper arm.
On the evening of Jan. 30th I was itching at the site and when I looked there was a large rash the approximately 3 to 4 inches in diameter.
Narrative:  71yo male patient died of covid positive pneumonia at community hospital (outside agency) on 10/17/2021. Pt had received 3 moderna vaccines on 2/26/21, 3/29/21 & 9/16/21. Patient was a 71 yo male with PMH vtach s/p AICD/pacemaker, NSIP (was on home O2), tongue cancer s/p resection, chemo and radiation. Treatment meds for covid positive infection unknown due to outside agency hospital. Failure of 3 covid vaccines but likely pt was immune compromised given cancer diagnosis.
Itching, redness, swelling at injection site. Indicates at the Clinic evaluation that she has an Epi-Pen for possible allergen to ibuprofen or food allergen several weeks prior.
This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 01-AUG-2017, the patient received an improperly stored dose in immunization series of GARDASIL 9 injection (lot # N013695 with expiration date at 21-MAR-2019; strength, exact dose, route of administration and anatomical location were not reported), for prophylaxis. The administered dose of vaccine was exposed to a temperature of 32 degrees Fahrenheit (F) for 168 hours. There was no previous temperature excursion. Data logger was not used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several report received form the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA004073: US-009507513-1708USA004071: US-009507513-1708USA004072: US-009507513-1708USA004070:
Child is reported by mother to be very out of character and fussy. Child wakes at night for hours at a time crying consolably. He is "just not acting himself."
Cramps; Chills; Bruises change from red to dark blue; Bruises on my right leg; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruises on my right leg), MUSCLE SPASMS (Cramps), SKIN DISCOLOURATION (Bruises change from red to dark blue) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced CONTUSION (Bruises on my right leg). On 08-Apr-2021, the patient experienced SKIN DISCOLOURATION (Bruises change from red to dark blue). On an unknown date, the patient experienced MUSCLE SPASMS (Cramps) and CHILLS (Chills). At the time of the report, CONTUSION (Bruises on my right leg), MUSCLE SPASMS (Cramps), SKIN DISCOLOURATION (Bruises change from red to dark blue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. In 2021, Urine analysis: concentrated urine (abnormal) concentrated urine.         No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
HEADACHE, SEVERE JOINT PAIN, RIGHT UPPER CHEST PAIN, LETHARGY, FEVER, CHILLS
Allergic to fur of the Cat hair/allergic to Cat hair; Feels like Hay fever; Watery eye; Itching; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO ANIMAL (Allergic to fur of the Cat hair/allergic to Cat hair), SEASONAL ALLERGY (Feels like Hay fever), LACRIMATION INCREASED (Watery eye) and PRURITUS (Itching) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO ANIMAL (Allergic to fur of the Cat hair/allergic to Cat hair), SEASONAL ALLERGY (Feels like Hay fever), LACRIMATION INCREASED (Watery eye) and PRURITUS (Itching). At the time of the report, ALLERGY TO ANIMAL (Allergic to fur of the Cat hair/allergic to Cat hair), SEASONAL ALLERGY (Feels like Hay fever), LACRIMATION INCREASED (Watery eye) and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. It was reported that the patient had an unusual side effect after completing primary series of vaccine of Moderna COVID-19 Vaccine. It was mentioned that the patient had never had any sort of complication in the past medically nor with pets. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route of administration). No treatment information was provided by the reporter.
Tachycardia, resting heart rate ranging from 105 - 116 for several hours
4 days post vaccine patient developed status migrainosus; subsequent muscle rigidity, visual disturbance, balance/gait disturbance, diffuse muscle pain.
Information has been received from a registered nurse who on 11-DEC-2007 was accidentally splashed in both of her eyes and on her hands with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) when plunging the withdrawn reconstituted vaccine back into the vial to facilitate the mixing of the vaccine and diluent. The measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) vaccine leaked from the connection between the needle hub and the syringe and splashed into both of her eyes and onto her hands. The nurse irrigated both her eyes with tap water and washed both hands with soap and water. The nurse stated "both eyes felt irritated but the symptoms were resolving. There was no visual impairment. The nurse contacted her ophthalmologist, via phone, who suggested continued observation, and to call the office if irritation continued, or if she developed any visual difficulties. There was no product quality complaint. Additional information has been requested.
Information has been received from a nurse concerning unspecified number of patients of unknown age and gender. Patients' concurrent and historical condition were not reported. The reporter stated that unspecified patients received doses of improperly stored ROTATEQ (dose, frequency, lot# and expiration date were unknown) orally on unspecified dates. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a pharmacist refers to a female patient of unknown age. The pharmacist reported that on an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number: K009770; expiry date: 09-OCT-2015) (0.65 ml, subcutaneous) which was improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Parent described pt as unresponsive, extremely lethargic, very difficult to awaken, eyes rolling back in head. Pt was taken to ER.
Approximately 30 minutes after vaccination developed numbness on tongue and some difficulty swallowing.  Per recommendation of physician and client was given oral Benadryl 50mg, and observed for 1 hour. Symptoms resolved.  On 11/04/2005 spoke with the client and she related she had a headache that PM but this resolved as well.