chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  No information was provided regarding concurrent conditions, medical history, or concomitant medications. In or about 2013, a healthcare provider at a medical branch administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided).  In or about 2014, the patient was treated by a healthcare professional at the same medical branch for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
I had a scratchy throat and some congestion; my husband had just tested positive for COVID-19, so I took a home COVID-19 test that came back positive also. I called my doctor to let them know I tested positive for COVID-19, we opted for me not to take any medication. Although I was feeling better within a few days, it took me a couple of weeks to test negative on a home COVID-19 test.
Immunization was on Friday October 26 at about 3:30pm. Around 8pm becane a mild cough with irritation in throat and trachea. By 8:30pm neck felt swollen and some numbness below corners of mouth. Continued coughing, eyes red and yellow substance "oozing" from corners of eyes. General achey feeling in legs. At about 9PM took 50 mg of diphenhydramine. About 40 minutes late began breathing easier, "swelling" seemed to get better. Coughing stopped. Numbness in corners of mouth eased. Slept through the night. Saturday morning about 8am, still had throath "thickness" sensation, took 25mg of diphenhydramine. 10am Saturday morning all symptems were gone. Symptems did not return.
Pt received TDAP in left forearm (medic administered injection as TB skin test) sm c/o tenderness to site.
Ache; Body ache; Headache; She also received a 4th dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), MYALGIA (Body ache), HEADACHE (Headache) and EXTRA DOSE ADMINISTERED (She also received a 4th dose) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 017E21A, 031L20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Myelodysplastic syndrome, Allergy to chemicals (Talcum powder Allergy (the type they use on gloves)) and Immunocompromised. Concomitant products included EPOETIN ALFA (PROCRIT) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2022, the patient experienced EXTRA DOSE ADMINISTERED (She also received a 4th dose). On an unknown date, the patient experienced PAIN (Ache), MYALGIA (Body ache) and HEADACHE (Headache). At the time of the report, PAIN (Ache), MYALGIA (Body ache) and HEADACHE (Headache) had resolved and EXTRA DOSE ADMINISTERED (She also received a 4th dose) outcome was unknown.            Patient received all the doses in her deltoid muscle. Patient never tested to positive for Covid-19 and did not received any other vaccine with in 1 month prior to Moderna. When she received the First and Second dose her hemoglobin levels went up. No treatment information details were reported.   This case was linked to MOD-2022-504269 (Patient Link).
One day after receiving my Moderna vaccine I developed a red rash at the site of the injection.It was swelled, red and painful to the touch. After three  days the rash became less painful and itchy.The next day the rash was gone and my lymph node under my left arm was swelled and painful.The swollen lymph node lasted for a couple of days.On day eight my rash returned in the same place on my arm.It is not painful but a little puffy and slightly itchy.This has been one day ago and it is still the same at this time.
This spontaneous report was received from a healthcare worker regarding a 4 year old patient of unknown gender. There was no information regarding concurrent condition and historical medication. On 17-APR-2015, the patient was vaccinated with expired dose of PROQUAD (Merck), lot# J010159, expiration date-23-FEB-2015. No concomitant medication was reported. No product quality complaint was involved. No adverse effect was reported. The outcome of event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
The patient reported pain and erythema at the injection site starting a couple of hours after vaccination.  He stated that after 2 days the pain has not improved and that he would be going to an urgent care to get it checked out.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left 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: "Born prematurely" (unspecified if ongoing); "asthma" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "depression" (unspecified if ongoing); "known allergies:some antibiotics (both mild/hives)" (unspecified if ongoing), notes: known allergies:some antibiotics (both mild/hives); "known allergies:some antibiotics (both mild/hives)" (unspecified if ongoing), notes: known allergies:some antibiotics (both mild/hives). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative for covid with an at home test; Positive, notes: at-home covid test and it was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
numbness in right arm; tingling in right arm; Limb mobility decreased; This case was reported by a pharmacist via call center representative and described the occurrence of numbness of upper extremities in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 3LL4P, expiry date 19th October 2021) for prophylaxis.   On 13th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced numbness of upper extremities, tingling of extremity and mobility decreased. On an unknown date, the outcome of the numbness of upper extremities, tingling of extremity and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the numbness of upper extremities, tingling of extremity and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient experienced numbness and tingling in his right arm to where he cannot raise his hand fully. The events were ongoing. The reporter consented to follow up.
No fever - sleepy yesterday. PC from APRN - rash generalized - started belly, chest, back, face - none arms/legs - PC to State Epidemiologist - no link to other case afebrile Epi staff report vax assoc. Rash RT MMR.
small red area at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (small red area at the injection site) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (small red area at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (small red area at the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-048884 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-048884:Crosslinked case
11 pm. Chills, fever, aches, fingers felt, numb walking was painful. Saturday noon still felt weird but was able to walk and went to work. 10/15/10 called to tell us about this - states feeling much better. Recommended she see her health care provider and she did.
Narrative:  Patient had previously had an anaphylactic type reaction to an influenza vaccine. (swelling of tongue) From the chart: Advised Patient approx 2 weeks prior to todays' date to to consult his Primary for approval to take Moderna Vaccine. Patient states today that his primary gave him permission to take vaccine-patient has presented to the clinic with benedryl as well as albuterol inhaler. Patient had anxiety in taking the vaccine and had been down to see me several times prior to the administration of the vaccine. I advised him that he didn't have to take the vaccine. He would just have to submit to weekly Covid tests. Patient stated that he would go ahead and take the vaccine. I advised Patient that since he had a reaction to the flu vaccine, that he would have to stay with me for 30 minutes per CDC guidelines, in case he has a reaction. Within 5 minutes of administering the Moderna vaccine, the patient pulled out his inhaler and took 2 puffs, I asked him how he was feeling. He stated that he was ok, just give him a minute. I asked if he was having trouble breathing-he stated no, I'll be ok, just give me a minute. He stated that he needed to go to work and get some keys. I called his boss and let him know that Patient will be at the Covid clinic so that I can monitor him. Patient then took a Benadryl and another 2 puffs of his inhaler. I advised patient that I need to call a rapid and he stated, no, I'll be ok, just give me a minute. He states that he doesn't like any of the Dr's here. Rapid Response was called, I updated the Rapid Response team and told him that Pt said that his primary cleared him to the the Vaccine- Pt then states that it was his friend and not his primary that said that he would be ok to take the vaccine. The Patient's boss showed up and convinced him to go and get checked out by the ER, before he could come back to work. Patient then went to the ER. Attending attestation: Patient seen and evaluated in conjunction with the resident. Patient states he has had this reaction before in the past when he has had vaccines. This is nothing new to him. He states he would like a shot of medicine to make him feel better. He took po Benadryl prior to arrival. He was given an injection of steroid here. Reports he already feels better. He declines any further evaluation/work-up. He states he feels ready to go back to work. Again, he declined any further observation. He is to return immediately if any new concerns or symptoms develop whatsoever. He is understanding and agreeable. He was given prednisone burst rx.
a patient was given ACTHIB 8 days after the expiration date with no adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient with unknown age and demographics who was given HIB (PRP/T) VACCINE [ACT-HIB] 8 days after the expiration date with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect HIB (PRP/T) Vaccine (formulation, strength, dosage, route of administration, lot number, expiry date and administration site: unknown) for immunization.  On an unknown date, the patient was given HIB (PRP/T) VACCINE 8 days after the expiration date with no adverse event (expired product administered) (Latency: Same Day).  No lab data was reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
patient had a serious GBS reaction to their 4th Moderna mRNA vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of GUILLAIN-BARRE SYNDROME (patient had a serious GBS reaction to their 4th Moderna mRNA vaccine) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (patient had a serious GBS reaction to their 4th Moderna mRNA vaccine) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (patient had a serious GBS reaction to their 4th Moderna mRNA vaccine) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reportedly, patient had a serious GBS reaction to their 4th Moderna mRNA vaccine.  No treatment information was provided.  Company comment- This is a spontaneous case concerning a patient of unknown gender and age with no medical history reported, who experienced the unexpected serious (medically significant) AESI Guillain-Barre syndrome. A dose of SPIKEVAX COVID-19 VACCINE NOS, given as a fourth dose of COVID vaccine schedule, was administered. Onset date of the event was not provided, hence latency cannot be assessed.  It was reported patient had a serious GBS reaction to 4th Moderna mRNA vaccine. No further details were provided for medical review. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS is not affected by this report.
25AUG95 pm onset h/a, fever, sore throat, diff breathing, T104+; 25AUG95 seen @ ER by MD; 29AUG95 sore throat; 30AUG95 cont h/a, perspiring, sore throat seen by MD;
Fever, swelling, blurry eyes, throat closure, sores on tongue and swollen, hard to talk or speak or understand. Felt like eggs in shot were rancid.
Pain from injection site (Rt deltoid) to elbow, "lump" the width of her upper arm, warm and hard. Kept her awake the night.  Taking Advil q4hrs.  Improving, but still sore.
This spontaneous report as receive from a physician refers to a patient of unknown age and gender. Medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date were not provided). Secondary and concomitant therapies were not reported. On an unknown date, a patient received expired ZOSTAVAX recently that was about 3 months out of date. No adverse event reported. Additional information has been requested.
Bleeding form rash site; black and blues; rash over various parts of her body- back, arms, legs, stomach, head, and it has gotten worse; Uncontrollable itching; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: ENG6198, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 12Apr2021 at 15:00 (at the age of 57-years-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications received within two weeks were not reported. The patient didn't receive any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: ER8727, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 22Mar2021 at 15:00 (at the age of 57-years-old) for COVID-19 immunisation and experienced rash over various parts of her body- back, arms, legs, stomach, head. On an unspecified date in Apr2021, the patient experienced bleeding form rash site, black and blues, rash over various parts of her body- back, arms, legs, stomach, head and it has gotten worse, and uncontrollable itching. It was reported that it has been 8 months and she still have the rash. She have never had any skin issues in her life. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events included cream. The patient has been tested for COVID-19 since the vaccination on 01Sep2021 which included SARS-CoV-2 test via nasal swab with negative result. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
It was reported that a pt describes a red itchy swollen right thigh. The swelling was from the top of the knee to the top of the thigh. In addition, it was reported that he experienced pain in the R knee and increased sleep. Treatment was not provided. The pt had no report of adverse experiences following receipt of prior immunizations. The most recent information rec'd reports the outcome as resolved. The case is closed.
Patient received MENACTRA 0.5cc in LD then Tdap 0.5cc in RD. Immediately after receiving Tdap, pt fainted for 6 seconds and awoke with a convulsion that lasted for 4 seconds. Pt was lowered to the floor and placed in recovery position. Observed pt for 1/2 hour.
Large swollen area, about the size of tennis ball, but oval in shape; hot to the touch and red.
Patient called the next morning (6/24/2020) and stated she has a lump where the injection occurred. Also experiencing fever, malaise, and severe pain. Instructed her to ice the area and take acetaminophen. Call MD if fever does not subside in 24 hours.
I had a splitting headache on January 7, 2023. I had photophobia and could not get comfortable. I was sensitive to smells. It was more severe than my usual migraine and didn't respond to ibuprofen as usual. I called my dad; he is a neurologist. He advised me to go to the emergency department, but I declined. I finally went to sleep. The headache went away after I woke up. Now, I have an upper respiratory infection and I have tested negative for COVID-19. I have not had a fever. I have had a cough that includes pain in my throat and now in my chest. I have a runny nose with nasal congested. I've had to work from home for two days because the symptoms were severe.
Patient presented fever, vomit, headache and inflammation of right arm 20 min after vaccination. She took 1 tablet of TYLENOL the day of the vaccination. After 24 hours, patient presents inflammation and pain in right arm, symptoms improving.
arm soreness; chills; fever 101.9 Fahrenheit; backache; lightheadedness; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 68-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, batch number: not reported/ Lot Number: EM9809), via an unspecified route of administration, administered in Arm Left on 12Mar2021 08:15 (age at the time of vaccination was 68 years) as dose 2, single for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, batch/lot number: not reported), via an unspecified route of administration on unspecified date (age at the time of vaccination was 68 years) as dose 1, single for covid-19 immunization. Concomitant medication included atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported. On 12Mar2021 the patient experienced arm soreness, chills, fever, backache and lightheadedness. The patient underwent lab tests and procedures in which fever was 101.9 fahrenheit on unspecified date. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
This report describes virus in a 64 y.o. female who received Hep A Virus inactivated virus (Havrix). The vaccinee "recently" experienced a rash after receiving amoxicillin. Concurrent conditions were unspecified. She received an unspecified concurrent medication. On 1/23/02, the vaccinee received her first dose of Havrix. Approx 3 days later, she experienced a fever of 102-103 deg. She was seen in the MD's office, where unspecified Lab tests were performed. It was thought that the fever was associated w/a virus, "because unspecified kidney and liver abnormalities were noticed." The Sx's lasted for approx 3-4 days, and then the vaccinee was "fine". As of 2/15/02, the event had resolved.
Breakthrough case admission after 4 vaccines Moderna 1/21/21 Lot# 012L20A; Moderna 2/18/21 Lot# 016M20A;  Moderna 11/12/21 Lot# 013F21A;  Pfizer 12/1/22 Lot# GJ3275
Chronic urticaria developed within two weeks of booster shot.  Treated with steroids and Zyrtec, condition still persisting after 6 weeks.
pt recvd vax; fever, irritability, swelling at inject site, facial rash p/ shot; tx w/ IV ATBs; poss erysipelas as cause of some of these signs;