chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Symptoms like an allergic reaction; Flu like symptoms; Tiredness in her muscles; Shortness of breath (she feels it in her chest); Skin is itchy and feels as if she had a rash; A spontaneous report was received from a 50 year-old female patient, who received Moderna's COVID-19 Vaccine and experienced flu like symptoms, symptoms like an allergic reaction, tiredness in her muscles, shortness of breath (she feels it in her chest), and skin is itchy and feels as if she had a rash.    The patient's medical history included allergies. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (batch number 025J20-2A) intramuscularly for COVID-19 for infection prophylaxis.  On 30 Dec 2020, the patient received her first dose of the vaccine and later in the day she presented flu like symptoms and symptoms like an allergic reaction. She also reported she felt tiredness in her muscles, shortness of breath (she feels it in her chest), her skin is itchy and feels as if she had a rash but she didn't have a rash. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, symptoms like an allergic reaction, tiredness in her muscles, shortness of breath (she feels it in her chest), and skin is itchy and feels as if she had a rash, was considered not resolved.; Reporter's Comments: This case concerns a 50 year old female patient with medical history of allergies, who experienced a serious unexpected event of Hypersensitivity and NS unexpected events of Influenza like illness, Muscular weakness, Dyspnoea, and Pruritus. The events occurred on the same day when the patient received the first of two planned doses of mRNA-1273 (batch number 025J20-2A). Very limited information regarding the events has been provided at this time.  Based on temporal association between the use of the product and the start of the events, a causal relationship cannot be excluded.
Drug ineffective; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 76 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Jan2021 as dose 1, single (Lot number: 043L20A), on 25Feb2021 as dose 2, single (Lot number: 000A210), on 27Oct2021 as dose 3 (booster), single (Lot number: 014F21A) and on 07Apr2022 as dose 4 (booster), single (Lot number: 066K21A) for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "Stage 4 Prostate Cancer" (unspecified if ongoing); "Ambien allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Sep2022, outcome "unknown"; COVID-19 (medically significant) with onset Feb2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Feb2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 28Feb2023 05Mar2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300107490 Same patient, different drug and event;
I was having a sore throat and a stuffy head. The next day I started having a cough and I lost my voice. This was November 25th and in December I still had this cold happening, I was worried because I was going on a trip with my grandkids, so I went to my doctor on 12/7/22. I saw a PA and they said I had an acute upper respiratory infection. She gave a prescription for cefdinir 300 mg for about ten days twice a day and prednisone as well. I took a COVID-19 home test and it was negative and I was able to take the trip. When I done with the medication and home, I did have a night where I did get sick to my stomach and was up vomiting. I have had the cold up until recently and am still horse and still have the stuffy nose well and I am still getting my energy back to normal. I did feel better while we were on our trip and I am not sure if that was due to the weather or not, but I did feel better.
Tingling lips, tightening around throat. Called 911 they took patient to local ER.
Sore arm; Fever; body aches; chills; This is a spontaneous report from a contactable consumer or non-health care professional (patient). A 45-year-old male patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6203) via an unspecified route of administration and administered in Left arm on 05Mar2021 at 09:00 am as single dose for COVID-19 immunization. The patient experienced COVID-19 prior to vaccination and not tested post vaccination. The patient didn't receive any other vaccine in four weeks. The patient medical history and concomitant medications were not reported. On 06Mar2021, at 03:00 am the patient experienced Sore Arm, Fever, body aches and chills. The patient did not receive any treatment for events. The outcome of events was not resolved.  No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN 6199), in left arm and on 11Apr2021 as dose 2, single (Lot number: ER 8729) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Nov2021 as dose 3 (booster), single (Lot number: 011F22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products", start date: 12Nov2021, stop date: 12Nov2021, notes: Vaccine brand other: moderna. Concomitant medication(s) included: ESCITALOPRAM, start date: Jan2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Negative, notes: Home rapid test was negative on day 5; (25May2022) Positive, notes: Tested positive on home rapid test. Therapeutic measures were taken as a result of vaccination failure, covid-19.
syncopal with shaking lasting apx 2 seconds then rapid return to responsiveness.  PSOP 99 RA BP 78/56  then 102/50
Pfizer (age 5-11) vial was not diluted prior to vaccine administration .  Pfizer has been contacted, awaiting their response.
Two days after receiving the yellow fever vaccine, the patient experienced severe generalized pruritus. There was no rash or swelling. The same symptoms recured 2 days later. She reported to the ER and was given benadryl. Symptoms subsequently resolved.
Muscle weakness; She was able to stand up with walker and move to other chair. Her ability to do this has decreased by 50% to 75%; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakness) and MOBILITY DECREASED (She was able to stand up with walker and move to other chair. Her ability to do this has decreased by 50% to 75%) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Muscular dystrophy and Walker user (uses a walker from one chair to another).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness) and MOBILITY DECREASED (She was able to stand up with walker and move to other chair. Her ability to do this has decreased by 50% to 75%). At the time of the report, MUSCULAR WEAKNESS (Muscle weakness) and MOBILITY DECREASED (She was able to stand up with walker and move to other chair. Her ability to do this has decreased by 50% to 75%) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
Had flu vaccine 10-4-11. On 10-5-11 pt called had experienced some sweating, chills and nausea. On 10-4-11 Nausea. Also heavy/labored breathing yesterday.
Patient was given vaccine around 3pm on the 21st. She states that later that night, her arm start to itch and there was some redness at the injection site. As it progressed, the rash traveled further down her arm and covered the top portion of her arm. She states that it just itches. The area looked inflamed and very red. The skin was still intact.
2 days after receiving the vaccine,  I felt a severe pain in my chest/stomach area, centered just below my rib cage. It hurt when I was laying immobile, and it hurt even more when I moved. The pain lasted for approximately 4 days, by the third day I the pain had lessened considerably, and on the fourth it was only present when I was upright for extended periods of time.
headache for a day body soreness for a day nausea for a few hours rash on arm for 2 days
LOCALIZED REACTION WITH REDNESS AND SWELLING THE THE UPPER RIGHT ARM. PATIENT DENIED ANY ITCHING OR PAIN TO THE AREA OF CONCERN.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient with no drug allergies. The patient's concurrent conditions and medical history were not reported. On 09-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX dose and route were not reported (lot# reported as K024031, expiration date: 20-FEB-2016). Concomitant therapies included fluoxetine, glimepiride, lisinopril (manufacturer unknown) and metformin. The pharmacist reported, that the patient came back to the pharmacy on 12-MAR-2015 with a red, hot, 6 inch lump at the injection site (onset date of the event: unspecified date in March 2015). The reporter stated, that there was no rash or itching present. The patient did not seek medical attention. No treatment was given for the event. The outcome of the event was reported as recovering/resolving. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
he was not feeling well; Really swelled up; his arthritis is getting worst; Hard of hearing; This is a spontaneous report from a contactable consumer (Patient). A 73-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on 27Jan2021 (Batch/Lot Number: EL9265) as single dose for covid-19 immunisation. Medical history included none. There were no concomitant medications. On 10Feb2021, the patient experienced really swelled up, his arthritis is getting worst, hard of hearing and he was not feeling well on an unspecified date. The action taken in response to the event for BNT162B2 was not applicable. The outcome of event he was not feeling well was unknown while for the rest of the events it was not recovered.
Vial was initially stored in the refrigerator on 21JUN2022, vaccine administered on 19Sep2022; No adverse event; Patient received vaccine after the 30 days beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 21JUN2022, vaccine administered on 19Sep2022) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 21JUN2022, vaccine administered on 19Sep2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 21JUN2022, vaccine administered on 19Sep2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 21JUN2022, vaccine administered on 19Sep2022).    No concomitant medication information was provided. The vial size was reported as 2.5 ml. It was reported that Lot AS1414B was moved from the freezer to the refrigerator on 21-Jun-2022. It was reported that the vial did not undergo temperature excursions. None of patients reported experiencing any symptoms after receiving those doses.  No additional doses, medications or treatments had been administered in response.   This case was linked to US-MODERNATX, INC.-MOD-2022-654159, US-MODERNATX, INC.-MOD-2022-654164, US-MODERNATX, INC.-MOD-2022-654157, US-MODERNATX, INC.-MOD-2022-654167, US-MODERNATX, INC.-MOD-2022-654171 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654164:Patient 3 (same reporter) US-MODERNATX, INC.-MOD-2022-654159:Patient 2 (same reporter) US-MODERNATX, INC.-MOD-2022-654157:Patient 1 (same reporter) US-MODERNATX, INC.-MOD-2022-654167:Patient 5 (same reporter) US-MODERNATX, INC.-MOD-2022-654171:Patient 6 (same reporter)
A few days after my vaccine I had been at work and I noticed that I could feel my heart pounding in my throat. It was going so hard at one point I almost had a hard time swallowing.  I tried brushing it off as maybe I was super tired or dehydrated but then it kept happening all weekend, different times but usually upon standing up suddenly or getting up from bed in the morning etc  I had talked to several nurses who are clients of mine about it and they advised me to go to my doctor if it continues but unfortunately they were hearing a lot of that in recently vaccinated people. It eventually just went away and I?ve not had trouble since, even after my second dose.
Patient reported she left pharmacy following 2nd SHINGRIX vaccination, and started walking back to home approximately 4 miles from store. She reported she started having severe pain/paralysis on left side of body, to the point where she said she needed assistance from family members to dress/eat/use restroom/etc. She reported this went on between Friday (day of vaccination) and Monday. She did not call her doctor or call any medical professional during this time period. She did not go to an urgent care location or an ED, nor call an ambulance. She stated by Monday she was able to freely lift her arm again and ambulate as she could before.
This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 37-year-old female patient who received Herpes zoster (Shingrix) (batch number Y537X, expiry date 19th May 2023) for prophylaxis. Concurrent medical conditions included breast feeding (had been breastfeeding for 5 months). On 9th December 2021, the patient received Shingrix. On 9th December 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional details were provided as follows: Health care professional(HCP) reported a 37 year old breastfeeding woman received the Shingrix inadvertently instead of a varicella vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administered. No reactions reported. HCP mentioned that she had been breastfeeding for 5 months. The consented to follow up.
Vomiting, Nausea, Headache, Body aches: started 12 hours after vaccine
I bit down on a hard bit of crust on some macaroni and cheese and split my tooth (tooth no. 19, lower right mandibular first molar).  I have no idea whether this was actually related to the vaccine and have no evidence that it was, other than the fact that this has never happened before.
12h after 2nd dose, 103deg fever developed after I went to bed.  Kept fever under control with Tylenol and Advil.  Fever Lasted 36h.   Flue-like symptoms with extreme fatigue started at time of fever and also lasted roughly 36h. Felt mostly normal in 48h, with the exception of brain fog and weak feeling muscles and joint pain.  The following day feeling of euphoria started. This lasted roughly 4 days.  After the euphoria wore off, extreme chest pains presented with abnormally pounding heartbeats that were felt in the chest and throat.  The strange heart beats were causing nausea, shortness of breath, and more fatigue.  This lasted 3 weeks. After the 3 week period, chest pains and heart beat returned to normal.  Joint and muscle pain persisted for an additional 3 months.  Brain fog has slowly improved but unsure that it has completely returned to normal.
This case described a 40 year old female pt who believe she contracted Lyme disease following receipt of Lyme disease vaccine recombinant OspA (Lymerix) for prophylaxis. This report was received from the pt and has been verified by a physician.  The pt received Lymerix on 03/07/00, 04/07/00 and 04/10/01. The pt stated that in August 2003, she began to experienced a leg rash, memory loss, "severe" fatigue, chills, joint achiness, and loss of appetite. The pt believed that she had Lyme disease.  Additional information was received from the treating physician on 10/31/03.  The pt presented to him on 08/19/03 with rash, fatigue and diffuse joint pain of approximately two weeks duration.  A presumptive diagnosis of Lyme disease was made and the physician prescribed a 21 day course of doxycycline.  Subsequently, Lyme Western blots were negative.  As of 10/21/03, the "symptoms were improving with therapy."
Immunized 10/13/99, pt developed swelling of l/arm that evening.  10/14/99, pt had l/arm swelling, fever & chest pain. Went to clinic, BP 200/168, called ambulance, pt hospitalized in ICU.  BP under control, swelling in arm decreased.
Itching; Tingling; itching on my skin; it seems to be getting worse instead of better; I cannot sleep, all throughout the day and it has been driving me crazy; this is driving me crazy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset Dec2022, outcome "unknown", described as "I cannot sleep, all throughout the day and it has been driving me crazy"; PRURITUS (non-serious) with onset Dec2022, outcome "unknown", described as "Itching"; PARAESTHESIA (non-serious) with onset Dec2022, outcome "unknown", described as "Tingling"; CONDITION AGGRAVATED (non-serious) with onset Dec2022, outcome "unknown", described as "it seems to be getting worse instead of better"; PRURITUS (non-serious) with onset Dec2022, outcome "unknown", described as "itching on my skin"; FEELING ABNORMAL (non-serious) with onset Dec2022, outcome "unknown", described as "this is driving me crazy".  Additional Information: It was reported that patient got the Pfizer Bivalent Booster (Clarified as COVID -19 Vaccine Bivalent Booster) 2 days ago and patient had a lot of itching, tingling, and itching on my skin and it seems to be getting worse instead of better. Well, who was somebody supposed to call than Pfizer. I mean because this was driving me crazy. Patient cannot sleep, all throughout the day and it has been driving me crazy. I mean I got the other three shots by Pfizer (Further name of the shots could not be clarified. Hence, captured as unspecified shots) and I had a little bit of pain, you know, a little bit of difficulty but nothing like this. This was the worst, and I must say that there is nobody to talk to at Pfizer at night-time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
left thumb infection; swollen face; extremely red swollen eyes; extremely red swollen eyes; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Jun2021 17:30 (Lot number: ER8731) as dose 2, single for covid-19 immunisation. Relevant medical history included: "RA", start date: 2001 (ongoing); "surgery", start date: 01Jul2021 (unspecified if ongoing). Concomitant medication(s) included: RINVOQ taken for rheumatoid arthritis (RA), start date: Jul2020, stop date: Jun2021. Vaccination history included: Bnt162b2 (Dose 1, Batch/lot number: EP7534, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Time: 5.30 pm), administration date: 14May2021, for COVID-19 immunization, reaction(s): "Tired", "headache", "extreme fatigue", "Bad RA flare", "hot,cold", "red face", "In bed 3 days", "joint pain from RA got worse", "joint pain from RA got worse". The following information was reported: LOCALISED INFECTION (hospitalization, medically significant) with onset Jun2021, outcome "not recovered", described as "left thumb infection"; SWELLING FACE (non-serious) with onset 05Jun2021, outcome "recovered" (06Jun2021), described as "swollen face"; OCULAR HYPERAEMIA (non-serious), EYE SWELLING (non-serious) all with onset 05Jun2021, outcome "recovered" (06Jun2021) and all described as "extremely red swollen eyes". The patient was hospitalized for localised infection (hospitalization duration: 6 day(s)). The event "left thumb infection" was evaluated at the physician office visit and emergency room visit. With second dose the patient experienced the following events: next day woke up with swollen face, extremely red swollen eyes, took a diphenhydramine (BENADRYL) and got better by next day. Left thumb infection got worse, went to urgent care on 21Jun2021 took antibiotics for a week, did not work. Rheumatologist sent her to ER on 29Jun2021, bad thumb infection went to trauma unit in another hospital. Wanted to amputate thumb, said no.  Had surgery on 01Jul2021. Took cultures and bone biopsy (unknown results). Treated for infection, in hospital 6 days at home IV with pic in arm with daptomycin. Didn't have problem with infection until after vaccine. Thumb hurt some before, but it could have just been joint pain from RA; stopped RINVOQ. Getting no treatment for RA afraid to suppress immune system.  Follow-up attempts are completed. No further information is expected.