chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Longer than Recommended Interval/received first dose at pharmacy and didn't complete series; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received 1st dose on an unknown date at pharmacy).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Longer than Recommended Interval/received first dose at pharmacy and didn't complete series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date 20 Jul 2023: The patient received first dose at pharmacy and did not complete the series. The reporter asked should the series be restarted? Till the time of reporting the patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.
High fever approx 100, giving Tylenol 6 hourly and continued for 2 days, today 12/20/2015 my son complained about headache on and off and diarrhea. Continuing Tylenol for fever and pains.
I started with a sore throat that progressed to body aches and fatigue. I started having fever and nasal congestion along with a headache and coughing. The symptoms got worse like a bad cold and fever. I was not home but I had test kits with me. My daughter called me and told me she tested positive so I tested immediately and I was negative. That was on June 28th. I felt like I had a fever and increased coughing. I tested again and was still negative. I decided to go to the pharmacy and have a PCR test. I took another test on that Wednesday and the COVID-19 Rapid test was positive. My PCR test was also positive. The nurse called the next day and she ordered the antiviral Paxlovid  which I started last night. I no longer feel like I have a fever and I generally feel a little better. I have also been taking Tylenol to treat the symptoms. I have not fully recovered yet.
Began with itching on forearms, particularly right arm. Welts & rash appeared. Lost hair on arms. Relief, but little healing. From FLORASONE cream 10% cardiospermum. Relief & better healing from numedica immuno PRP spray.
pt  stated they had redness, and  alot of swelling at site. also had nausea, diarrhea, body aches and elevated temperature.  No treatment stated, feels better now
Patient reported pain on left side that made deep inhalations difficult. Pain started below breast and radiated towards the back. The pain began the day after receiving the second Shingrix dose. The pain was most intense on that day, and has slowly improved. She is still in some pain 3 days later, but can take deep breaths more easliy/comfortably.
Nasuea, Fever, chills, headache, body aches, swollen lymph node, arm pain for 24 hours that began 14 hours after shot continual runny nose since shot, ongoing chills since shot, sore nostril,
painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR050636   Additional Information: GSK Receipt date: 16-MAR-2023 This case was reported by a patient via interactive digital media. The patient haven't gotten shingles yet but had the vaccines last fall. The patient first shot was a bitch, more painful than any flu shot. Must have had the consistency of maple syrup. The booster not nearly as bad, but the condition was worse, her/his sister had it a couple of times. The follow-up could not be possible as no contact details were available. For tolerance to the Flu shot case refer FR2023007617.; Sender's Comments:  US-GSK-US2023AMR050636:same reporter
Itchy lesions on the inside of his left foot; 3 days later the lesions spread to both feet and the lower ankles. He presented Monday a.m. complaining of lesions on feet. He was asymptomatic o/w (no fevers/chills, malaise, nausea, etc.). Assessment: dull, red, flat papules w/ bullseye lesions on ankles and top of feet (erythema multiforme). Chest, arms, back, groin buttocks clear of lesions.
This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On 16-MAR-2015, the patient was inadvertently vaccinated with a dose of PNEUMOVAX23 (lot #, dose, frequency and route were not reported) that was expired on 25-FEB-2015. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
t103.5; face turned pale-waist down turned blue; gasping for air, nurse felt pt was holding breath; crying 2 hrs @ most; pt was cold-stuffy nose;
This spontaneous report as received from a licensed practical nurse refers to a 18 month old patient of unknown gender. The patient's concurrent conditions, medical history, drug allergies and concomitant medications were not reported. On 18-SEP-2014 the patient was inadvertently vaccinated with GARDASIL (lot#, exp. date, route of administration and vaccination site were not reported). No adverse events were reported. No laboratory tests were reported. Additional information has been requested.
Couldn't lift L arm. Swollen x 3 times size of other arm. Hot low T 100.8 crying non stop. Swollen shoulder-elbow red line up neck went to ER.
Myalgia, Fever, NauseaVomiting,  Chill Narrative:
Induration, vesicular eruption 4x4cm at site of vaccine within 48 hours of administration.
This spontaneous prospective pregnancy report as received from a 28 years old female consumer, for VARIVAX (Merck), a Pregnancy Registry product, concerning herself, with no medical history and concomitant condition. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated SC. with a dose of, 0.5ml VARIVAX (Merck) (lot# 0428AE, expiration date 27-FEB-2014) on 18-JUL-2012. There were no concomitant medications. The patient was pregnancy before getting the vaccine. The patient said that she might be five or six weeks pregnant. The patient's LMP was approximately on 18-JUN-213 and EDD was on 25-MAR-2013. Initial exposure to VARIVAX (Merck) was approximately 4 week(s). The patient was exposed to a VARIVAX (Merck) during trimester 1. No adverse events reported. No treatment information was reported. The outcome of patient was unknown. The patient had done annual obgyn visits and sought for unspecified medical attention. Additional information has been requested.
Patient received the Pfizer vaccine. When patient rose to go to observation, he experienced a witnessed syncopal episode. The patient fell backward. Upon approach, patient's eyes were closed. Patient was diaphoretic. He was placed on a mat.
A few hours after receiving vaccine, patient reports extreme fatigue, headache, sore arm at injection site and nausea. This resolved around 18 hours after the vaccine.
The day of my vaccination my arm was sore when I got the injection and under my arm as well. The day after my vaccination I felt a little draggy and my arm was sore. That night I was very tired and had some chills. The second day after my vaccination I had a large lump on my arm around the injection site and I felt really bad: body aches (particularly my back), headache, extreme fatigue, temperature of 99, sudden intense itchy spots. I felt like lead and I was exhausted. I took Tylenol and spent most of the day in bed. I had some cups of bone broth. By evening I was feeling a little better. The third day I felt better, but tired. The fourth day (the day I'm submitting this report) I feel much better, but still a little tired. My arm is still store (but better) and the lump is almost gone.
pain at injection site, muscle and joint aches, headaches, foggy feeling, chills, tiredness (much flu-like) - for about 48 hours
PATIENT HAD VACCINE ON 8/8/21. ON 8/17/21, SHE WENT TO SEE DR. FROM THE TIME OF THE VACCINE ADMINSTRATION, LEFT ARM BECAME RED, SWOLLEN, AND SORE. THIS HAD SPREAD DOWN THE ARM FROM THE INJECTION SITE. THE DOCTOR TOLD PATIENT THAT THE ISSUE WITH THE ARM MAY HAVE BEEN  BECAUSE THE VACCINE WAS ADMINISTERED TOO LOW IN THE ARM. PER PATIENT, THE DOCTOR THOUGHT THAT PATIENT COULD BE BEEN BITEN OR STUNG BY A BUG. THE DOCTOR THOUGHT IT COULD ALSO BE CELLULITIS. AT THAT VISIT, THE PATIENT WAS TOLD TO CONTINUE THE DIPHENHYDRAMINE AND ICE THERAPY. SHE WAS ALSO TOLD TO TAKE ZYRTEC, PEPCID AND WAS GIVEN DOXYCLYCINE. THE NEXT DAY (8/18/21), THE PATIENT REPORTS THAT THE AREA AROUND THE INJECTION SITE BECAME DARK PURPLE. SHE WENT TO THE ER. THE ER TELLS PATIENT THAT SHE HAS EXPERIENCED A REACTION TO THE COVID VACCINE. NO ADDITIONAL CARE IS PROVIDED. SHE IS REFERRED BACK TO HER DOCTOR IF ANY PROBLEMS PERSIST. THE PATIENT REPORTS RESOLUTION OF SYMPTOMS ABOUT 2 WEEKS AFTER THE INITIAL INJECTION. PATIENT RECIEVED HER SECOND COVID VACCINE WITHOUT ANY ISSUES.
Pfizer-BioNTech COVID-19 Vaccine   Tingling from injection site to mid forearm
Admitted for agiation, admitted for ECF placement. Found to be covid +, no sx. No tx needed. Remained in isolation. Insurance denied SAR, was d/c home.
Right sided chest pain, right sided flank pain, right knee pain, fever of 101. F, dyspnea while ambulatory. Easier not to talk
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an adult male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 14-DEC-2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unspecified date, the patient was treated at a physician's office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received bnt162b2 (COMIRNATY), as dose 3 (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, reaction(s): "sore arm"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Additional information: All of her previous 4 covid vaccines and boosters, the last one in Jun2023, have been from Pfizer and the most she got from them was a sore arm..   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300324950 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300325059 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300325060 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300325057 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300325070 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300325071 Same reporter, Patient / Different AE, Vaccine Dose;
Severe pain at left arm, just below injection site, with radiation to left shoulder and left elbow.
Patient diagnosed with COVID 11/2020.  little to no symptoms reported at that time except fatigue. Vaccinated 2/1/21 and 2/20/21. Admitted to HCF 5/30/21 with SOB. COVID + on 5/30/21. Treated with steroids and Remdesivir x 2 days DIscharged 6/2/21. Admitted to our facility 6/7/21 through 6/11/21 with possible COVID PNA.   Thought could also be a CHF exacerbation.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-016540 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Additional information received on 26 Apr 2021. No additional information provided.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-016540:dose 1
Information has been received from a registered nurse referring to a 12 month old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was inadvertently administered a dose of PROQUAD injection (lot # L044055, expiration date 02-MAY-2017, rHA (recombinant human albumin); dose and route were unknown, for prophylaxis), instead of an intended dose of measles, M-M-R II. The patient was also administered VARIVAX injection (lot # L015045, expiration date 29-APR-2017; dose and route were unknown, for prophylaxis). M-M-R II was not administered. The reporter stated that she confused the PROQUAD for M-M-R II, because they were stored in the same compartment of her freezer. When she read "measles, mumps, rubella", she thought it was M-M-R II. The reporter remarked she did not notice the difference because the type on the vaccine labels was so small. No adverse effect was reported. Additional information has been requested.
Patient reports a major escalation in suicidal ideation beginning the day after vaccine and continuing.  He has not sought medical attention but at one point was near going to Emergency Department. Patient also reports ringing/deafness in right ear that is currently unresolved Patient reported shaking for several days after the vaccine but that has resolved.
11 am severe nausea, headache, balance problems.   by 1pm Vomiting started, headache got worse by 4 tingling sension and headache and vomiting continued Around 4am slight fever, vomiting continued  Next day vomiting  stops mid day, still some balance problems very weak , dizzy ness, balance problems headaches  Day 3 still slight headache, light bothering eyes  waves of nausue throughout the day extremely tired  Day 4 Extremely tired, nausea wave 1 or 2 times but able to eat, slight headache, balance normal  Day 5  slight headache , tired
Patient developed a red rash with swelling and pain associated that covers her entire body.  Patient also experiencing diffuse body aches
Very rapid heart rate and a feeling in the back of my throat as if it were becoming numb.  I had a difficult time swallowing; mouth was very dry.  I was fortunate to have a bottled water in the car as I drove home to keep sipping on.  The heart rate corrected itself within a half hour of onset but my throat continued to feel numb for at least five hours after onset. I have had seasonal flu shots for years with no reaction.  I belive that this was definitely injection-related.
shingles; This is a spontaneous report from a contactable consumer(patient) received via Pfizer sales representative. A 25-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. Medical history included tetanus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other medications had gotten the shingles one week after getting the second vaccine, no other medications had taken just gotten a tetanus shot a few weeks before. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection; Lot number was not reported), via unspecified route of administration on an unspecified date as single dose for covid-19 immunization. On an unspecified date the patient experienced shingles. Event took place after use of product. The outcome of event was unknown.  Information about Lot/batch number has been requested.
Pt fainted after vaccination, upon assessment patient was conscious and responsive. we monitored oxygen levels, blood pressure, and breathing for approximately 30 minutes while patient was laying down and recovering.  Patient was able to achieve normal vital signs by the end of 30 minutes and was  observed getting into the vehicle safely. Instructed parent of child to be seen immediately at Urgent Care or Emergency Room for further evaluation and to rule out any injuries from fainting.
pain in the area between ring and pinky finger.; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in the area between ring and pinky finger.) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the area between ring and pinky finger.). At the time of the report, PAIN IN EXTREMITY (pain in the area between ring and pinky finger.) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2023: Live significant follow-up received on 15 Nov 2023, Reporter, patient, Product, Event information.
Pt recvd 3 doses of Engerix-B & did not seroconvert; Booster doses were administered; No tx was given;
Starting a day or two after the second shot, I began experiencing noticeably severe hormonal changes.  My period, always regular, came 2 days early and was heavier than usual with greater pain.  Since then, I have not gotten another period but I have had extreme mood swings, period of uncontrollable crying (not linked to any other event in my life), intense fibroid pain, constant hormonal acne, new cold sores popping up almost every morning and constant recurring yeast infections.   Nothing was or is different about my health, lifestyle, medications or any other factor other than the vaccine.
Spiked fever 104.1 per parent, post IPV injection, patient to emergency room later same day - (ER notes included).
1DEC97 6Pm pain lt deltoid;2DEC97 AM awakened from sleep w/throbbing pain into forearm;motrin helped;tingling lt digits of hand 3DEC97;
My IC went out of control I was able to see my doctor every four weeks for installations after getting the vaccine I started having to go twice a week to almost every week. This has been going on for  8 Months now no change no reliefs
Patient complaint of light headness after shot lasted for about 5 minutes then went away prior to patient leaving
Information has been received from a physician via a field employee referring to a 14 year old female patient. The patient's concurrent condition and medical history were reported as none. Information about drug reactions/allergies was unknown by the reporter. The patient was vaccinated with either GARDASIL or GARDASIL 9 (unidentified Merck hpv vaccine) (strength, batch/lot number and expiration date unknown; every dose of 0.5ml, first dose on 14-OCT-2014, second dose on 23-DEC-2014, third 15-APR-2015 respectively) intramuscularly for prophylaxis. On an unknown date (reported as after a few weeks after the first shot, also reported as the patient was 14 years old), the patient had headaches that persisted. The patient self-treated with ibuprofen and naproxen sodium (ALEVE). There was no sought medical attention. The outcome of headache was reported as continued to this day (not recovered). The causality assessment was not provided by reporter.
diff breathing, tightness in chest, numbness in arms, hands, face, lips etc;tx epi, DPH Decadron & Iv fluids, recovered completely in less then 24hr;
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication not reported. Treatment medication not reported. This case was linked to US-MODERNATX, INC.-MOD-2021-103058 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-103058:Case for husband.