chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm was swelled to my elbow; Arm sore; This case was reported by a consumer and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were unknown.   It was unknown if the reporter considered the swelling arm and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, after vaccination with dose of Shingrix, the patient experienced arm swelling to the elbow and arm soreness. The patient stated that, could not remembered, if being this tired. .
Cough; 102.4F Fever; Vomiting; Seemed a bit fuzzy; This non-serious spontaneous safety report, with case number 02239608/02239593, was received by partner, on 02-SEP-2022 and forwarded to agency on 05-SEP-2022 from a consumer.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Fuzzy, Cough, Fever, and Vomiting".  Further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2016, a pharmacist at a pharmacy administered the ZOSTAVAX (lot# and route unknown) vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, 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 include 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 were considered not resolved. Causality assessment was related. Additional information has been requested.
Food poisoning; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of FOOD POISONING (Food poisoning) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced FOOD POISONING (Food poisoning) (seriousness criterion hospitalization) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, FOOD POISONING (Food poisoning) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.         Patient was hospitalized due to severe health problems during pregnancy. The were no severe health event due to complication of patient pregnancy.  Company Comment - This case concerns an adult female patient with no relevant medical history, who experienced the serious unexpected event of food poisoning and maternal exposure during pregancy. The event occurred on an unknown date after a dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.  Relevant concomitant medications were not reported.  Treatment information was not provided.; Sender's Comments: This case concerns an adult female patient with no relevant medical history, who experienced the serious unexpected event of food poisoning and maternal exposure during pregancy. The event occurred on an unknown date after a dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Patient have taken the shingle vaccine and had a reaction to it; Information has been received from a female patient of unknown age via Novartis, referring to herself. Information of concurrent condition, medical history and concomitant therapy was not provided.    On an unknown date, the patient taken zoster vaccine live (ZOSTAVAX) (dose, strength, route, lot# and expiration date were unknown) for prophylaxis.      On an unknown date, the patient had a reaction to it. The outcome of the event was unknown. The relationship between the event and zoster vaccine live (ZOSTAVAX) was related.
Patient was administered Moderna 0.5 mL IM. Patient was monitored for 15 minutes after immunization. Patient had no abnormal signs or symptoms. Patient discharged.
Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Additional Details: Pateint fainted after getting her first dose of the vaccine. Patient fainted while sitting in the chair, the immunizer led her down to the floor. Patient was alert in 20 seconds of fainting, she was not aware of what had happend. Patient was asked if she was having difficulty breathing. Patient was having hard time resposing, epinephrin was adminstered and 911 was called at 11:29am.
Pt. fully vaccinated with COVID19 Janssen vaccine on 5/5/21. Pt. then had a high risk exposure to a COVID+ household member starting 10/6/21 - 10/9/21. Pt. took an asymptomatic PCR test on 10/9/21 and received a positive result.  Pt. reports COVID symptoms of Low grade fever, body aches, headache, shortness of breath with activity, sore throat, fatigue and cough starting 10/10/21.
1st dose 22Jul2022, 2nd dose on 07Oct2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 40-year-old female patient who received HAB (Twinrix) (batch number J477Y, expiry date 20th May 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (on 22 July 2022 received 1st dose with batch number J477Y, expiry date 20th May 2023).   On 7th October 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: The pharmacist reported that the patient received first dose of Twinrix on 22nd Jul 2022 and did not receive second dose until 07th Oct 2022.  At the time of reporting, no further doses had been administered.  The reporter consent to follow up. Additional Supportive Information: The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of the vaccine schedule.
My head hurts; My bones hurt all over; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer), Program ID: (133943).  A 53-year-old female patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 22Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; palbociclib (IBRANCE), since 22Jun2022 (ongoing) at 125 mg cyclic (125 mg, cyclic (daily on days 1 through 21 of each 28 day cycle)), oral for breast cancer. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Unknown Manufacturer), for COVID-19 immunisation. The following information was reported: BONE PAIN (non-serious) with onset Jun2022, outcome "unknown", described as "My bones hurt all over"; HEADACHE (non-serious) with onset Jun2022, outcome "unknown", described as "My head hurts". The action taken for palbociclib was dosage not changed. Additional information: Reporter seriousness for bones and head hurt: Unspecified. Patient had her first covid booster and started Ibrance the same time. Her bones hurt all over and her head hurts. Patient wasn't sure what caused it. The adverse event was non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt felt dizzy after administration. Had him lie down with feet elevated for five minutes. Pt was able to sit up again and rest for 30 minutes.  Was able to leave normally
sniffling; hoarse; tongue was swollen; This is a spontaneous report from a contactable Nurse (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 11Feb2021 (at the age of 68 years old) as dose 2, single for COVID-19 immunisation. Medical history included penicillin allergy, horrible rash, hospitalization, drug allergy (States 10-15 years ago she was in the hospital for a week after a drug reaction they believe). There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 20Jan2021 (at the age of 68 years old) as single for COVID-19 immunisation and experienced swollen eyes (after the first dose which she states might have been around 20Jan2021 she was fine other than swollen eyes that evening and the next day). The patient experienced sniffling, hoarse, tongue was swollen on 11Feb2021. Reported as, she received the second dose on 11Feb2021 and she was fine after the first 15 minutes when she we waited at the facility. she states then a little later she starting having some sniffling and then 30 minutes later she noticed she was hoarse. She got home about a hour later and her tongue was swollen but she had no problems breathing. two hours later the hoarseness went away. She does have allergies and has become hoarse a couple of other times, there are certain chemicals and things that can cause her to be hoarse. She did have a drug reaction to something a couple of years ago, states they think it was a delayed reaction to penicillin, just a horrible rash, no further information provided. Outcome of the event hoarse, tongue was swollen was recovered on 11Feb2021 and unknown for sniffling.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recvd vax & rt arm sore & swelling; 20OCT had fever 100.3 & arm more sore;21OCT had same fever arm more swollen & sore;22OCT woke up sweat drenched;bed & pillow wet-night gown wet;arm red, hot (very hot) & hard;heart raced w/sl exertion;
C/O tingling (L) arm shoulder to hand. (L) neck and face. Headache and chest pain.
Per mom, on the evening after vaccine administration, pt ran a fever with TMAX of 104 degrees rectal, pt was given TYLENOL and MOTRIN alternating, mom reports that next two days temp reached a max of 102 degrees rectal. No fever day 3 or after.
Pt developed mild induration, warmth and erythema at injection site. Doubt infection. Suspect local reaction. Pt to doctor and seek medical care from PCP or ER if worse.
Tested positive via rapid and PCR on 13Mar for COVID even though fully vaccinated; Tested positive via rapid and PCR on 13Mar for COVID even though fully vaccinated COVID-19 PCR test; This is a spontaneous report from a contactable nurse. A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in Arm Left on 05Jan2021 07:00 (Batch/Lot Number: EK9231) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Left on 25Jan2021 (Batch/Lot Number: EL3Z47) as SINGLE DOSE for covid-19 immunisation. Medical history included Irritable Bowel Syndrome with constipation.  There were no concomitant medications. Received both doses of the vaccine (1st dose 05Jan2021; 2nd dose 25Jan2021). Exposed to COVID on 10Mar2021, developed symptoms on 12Mar2021, tested positive via rapid and PCR on 13Mar2021 for COVID even though fully vaccinated. Health Department and testing center unable to hold specimen for variant testing. The events were assessed as serious (medically significant). The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive   on 13Mar2021 Covid test type post vaccination=Nasal Swab, Covid test name post vaccination=Rapid Abbott Test,. The outcome of the events was recovering.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported tested positive for covid-19, which is considered failure of COVID-19 vaccine BNT162B2, and the administration of BNT162B2.
getting 2-half doses of 0.25 mL a week apart doses are split with no adverse event; Initial information received on 16-Sep-2022 regarding an unsolicited valid non-serious case received from health professional. Agency number: 01282437   This case involves a 90-year-old female patient who would be getting 2-half doses of 0.25 ml a week apart split doses of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] with no adverse event.    The patient's past medical history of history of getting reactions to the flu shots (Drug allergy) with arm has gotten red after getting the flu vaccine (Injection site erythema). At the time of the event, the patient had ongoing Rheumatoid arthritis.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA388219.    On an unknown date, the patient would be getting suspect Fluzone QUADRIVALENT Multi-dose vial at dose 2-half doses of 0.25 ml a week apart doses are split with (unknown strength, form, lot, route, administration site) for prophylactic vaccination with no adverse event (intercepted product administration error).  Action taken: Not applicable.  At time of reporting, the outcome was 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
pt mom reports p/vax pt given APAP just in case;no fever;child felt fine;21AUG98 went to local fair ate, took bath when got home;mom reports water blister on chest, back, & few on arms;most nickel size;dx ear infect;?virus?vaccine;
pt c/o red streak from rt shoulder up over collar bone 7 one across chest 8-10" long;denies pain in inj site;no redness in inj site;pt applied hot & cold compresses;took ATB had @ home;sx gone w/in 24hr;
High Blood Glucose numbers.  After the first Pfizer Covid-19 vaccine, my blood glucose numbers went up, with morning fasting numbers in the 200's and then my numbers stayed up for the rest of the day. After about 10 days, the numbers went back to normal.  Then, when I went for my second vaccine, my blood glucose numbers went up again, with morning fasting numbers in the high 200's-low 300's.  During the day, the lowest they have been has been about 200.  I have never seen numbers like this before. Today marks 2 weeks since my second vaccine and my numbers are still high.  I work with a diabetic counselor who says that I am not the only person experiencing this.  I am hoping my numbers return to normal soon!
TINNITUS IN LEFT EAR. EXTREME DIZZINESS ON DAY 5. ONGOING VERTIGO SYMPTOMS INTO THIRD WEEK SINCE SECOND SHOT.  HEADACHE AND FATIGUE. ELEVATED BLOOD PRESSURE. 150 OVER 90.  DONT TAKE BP MEDS.
Extremely Heavy Period.  Felt like I was fainting all day and night.  (ddi not repot to doctor)
1/19/2021 - pain, tingling, numbness in hand, referral for MRI and neurological exam 2/08/2021 - increased pain, tingling and numbness in hands, Neurological exam and MRI review 3/04/2021  - significant pain, swelling, tenderness, warmth in hands, shoulders, arms, feet, legs, ankles; inability to grip, lift, raise arm 3/5 to 3/18/2021 - Increase in all symptoms 3/18/2021- Decrease in all symptoms with prednisone and methotrexate
rt thigh site of inj red, warm to touch, tender to touch w/in 24 hr;
Shortly after the vaccine I developed severe diarreah.  It was so bad that I could not hold it and had an accident on myself.  It was ad if I developed a really bad stomach virus.  I felt awful for about 2 days.   I reached out to my PCP who advised there was nothing I could take but to drink plenty of water and get rest.  I get severe stomach cramps that come off and on which feels like severe menustral cramps.  My lower digestive tract has been feeling really bloated.  I developed a strange dry cough about a week after.  It left on its on but returned.  I had a COVID test done that was negative. Because I was so tired, fatigued and not feeling well  I went to the  Urgent Care  and was advised that I had a severe Upper Sinus Infection.  My ears were really itchy and my sinus cavity was super swollen.  A strep test was neg and I was given Augmentin for the Upper Sinus Infection but still havent been feeling well.  The cough is off and on still.  I feel as if I am having some kind of serious Inflammation going on in my body because my whole body is super sore and walking and moving has become extremely challenging.  And I still get the lingering headaches periodically to date.  When I went to the Urgent Care my BP was abnormally high at 170/100 and never went down.  I had to return to the Urgent Care the next day to have my BP taken again and it was still elevated so I am now under the care  of a Cardiologist.
Significant increase in ringing in my ear (tinnitus). I have had ringing in my ears for 20 years but now the level is uncomfortably high, requires white noise to sleep.
Patient presented to the office for his Moderna booster vaccine (0.25 mL). It was brought to the attention of the vaccine manager, that the efficacy of the vaccines being administered that morning was diminished due to the length of time that the vaccine vial had been open for. The vial had been open for 24 hours at that point in time. The patient stayed under standard observation for 15 minutes and exhibited no ill effects.
itching; Asthma; Breathing problem; Due to pandemic, she never received the 2nd dose; shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) solution for injection in pre-filled pen for asthma and Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix, Nucala cyclically and the 2nd dose of Shingrix. In JUN-2023, more than 2 years after receiving Shingrix, an unknown time after starting Nucala and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). On an unknown date, the patient experienced pruritus (Verbatim: itching), asthma (Verbatim: Asthma), difficulty breathing (Verbatim: Breathing problem) and social problem (Verbatim: Due to pandemic, she never received the 2nd dose).  Nucala was continued with no change. The outcome of the shingles was resolved and the outcome of the pruritus was not resolved and the outcome of the asthma and difficulty breathing were not reported and the outcome of the social problem was unknown.   It was unknown if the reporter considered the shingles, pruritus, asthma and difficulty breathing to be related to Shingrix. It was unknown if the reporter considered the pruritus to be related to Nucala and Nucala Autoinjector Device.     It was unknown if the company considered the shingles, pruritus, asthma and difficulty breathing to be related to Shingrix. It was unknown if the company considered the pruritus to be related to Nucala and Nucala Autoinjector Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 09-SEP-2023 The patient self-reported this case. The patient stated that due to the pandemic and the loss of her husband, she never received the 2nd dose (inappropriate schedule of vaccine).  She also mentioned that during that time she started having trouble breathing and was later diagnosed with asthma.  The patient stated that she had Shingles in June 2023 and still had some residual itching now.  The patient started taking Nucala approximately 3 months ago.  She stated that she no longer had Shingles but still had itching, she called to inquire if this could be a side effect of the Nucala as she was unsure. The patient did not had time to continue the conversation so she did not provide HCP information during the call.  The patient stated the she received her dose of Shingrix at a pharmacy, however, she did not provide any additional details. The reporter consented to follow up.
Patient tested positive for COVID-19 3 days post vaccination. Patient tested due to facility wide testing. Patient asymptomatic at time of testing and remains asymptomatic. Patient placed in droplet isolation. Select vitamins added to medication regimen for increased healing.
Early a.m. 2nd day had bad headache. By 6 a.m., very tired with light occasional chills; headache continued - took 1 ibuprofen Day 3 very lethargic; no energy at all Day 4 bad lower intestinal pains  with eventual diarreah; extremely tired