chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had the shot and I got the shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided. The reporter asked the reason for having shingles after receiving vaccination. No further information was provided.
CHILLS; SORE ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. Batch number was not reported.  Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and the outcome of sore arm was not reported. This report was non-serious.
pt recv vax & 5hr p/vax pt devel an inj site rxn characterized by erythema & pruritus;pt recovered p/5 days;this is 1 of 9 pt from this facility to devel an inj site rxn p/flu vax w/lot# 4978139;
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 13-MAY-2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX 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 or about 27-JUL-2015, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe shingles. On or about 28-JUL-2015, the patient sought subsequent treatment from a physician for continued and worsening blistering outbreaks that were further diagnosed as shingles. The patient was prescribed acyclovir, morphine, and famciclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of the 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 further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Approximately 6 hours after receiving booster: Shooting blinding pain on contact with any part of body: eyelids, scalp, ribs, arms, back, all of it. Random pulsing, particularly down hip. Most faded after a few days but the pain in right side of hip comes every few weeks and stays for a couple days activating every few hours for a few seconds at a time. Leg in too much pain to move when this occurs.
I came down with Covid-19 a couple of days after receiving the bivalent booster.  Shot on  Sept. 19, sick evening of Sept. 21, 2022.   Bad neurological onset (I had severe paralytic polio in 1953), guess it got me where I?m weak.  Kept me up most of the night.  Next day had congested head and chest,  body, joint aches, awful headache, eyes hurt.  And that was the worst day, also the day when I tested positive.  Contacted a doctor, hoping for Paxlovid, but he was in a hurry  and gave me prescriptions for coughing and an inhaler.  Didn?t really need either as I already had the same cough pills and my chest wasn?t constricted.  However, this was only like a medium bad flu and I recovered on my own.  It took several weeks.  Others in my four person household came down with it one by one, but they did not report it.  For my son-in-law it was the second go round in about a month.
?Moderna COVID-19 Vaccine EUA?  Injection site pain, malaise, muscle pain, chills, headache, mild tachycardia (110-120),
I felt very floaty immediately after getting the vaccine, for about three hours after. About six hours later, I was in extreme pain that came on suddenly. My uterus had stabbing pain, and then my lower back did as well. About an hour later, I had nerve pain in my hands, legs, neck, feet, and my buttock cheeks. Everything was on fire. I honestly thought I was dying for a while there. I had a fever, and then my back started to ache like I had the flu, on top of the fire pain. I couldn't sleep much that entire night, for eight hours I laid there and it was excruciating; I thought that night would never end. I couldn't find a comfortable position all night, no matter which side of my body I slept on. The next day, it was a tiny bit better. On the first day I would say it was a 10/10 pain (10 being the highest), and this next day it was a 6/10. I still had uterus pain, and back pain, as well as a fever. I was in a brain fog, it was hard to think. I was extremely weak, I couldn't get out of bed, I had to do my college class in bed. Yesterday, it was about a 2/10 pain, it still lingered. I've been taking Tylenol every 6 hours, so it definitely kept breaking my fever. I will still take one or two today. Today, the pain is about 1/10. It is still slightly there in my back and uterus. I am in a brain fog, it is hard to think, and I am still weak. There is no way I will get a booster of this shot next year.
fever /  low grade fever; aches / pains; fatigue; This case was reported by a physician via call center representative and described the occurrence of fever in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on unknown date, refer case US2020223956) and Aspirin. Concomitant products included acetylsalicylic acid (Aspirin).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, pain and fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the fever, pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The case was reported by the husband of the patient. The age at vaccination was not reported. The patient received the dose of Shingrix right arm and she experienced fever, aches, pains, and fatigue with a low grade fever. For the second dose, she pretreated with aspirin and yet she had the same reactions. The symptoms lasted 24 hours and then resolved. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020223946:same reporter US-GLAXOSMITHKLINE-US2020223951:same reporter US-GLAXOSMITHKLINE-US2020AMR224583:same reporter US-GLAXOSMITHKLINE-US2020223956:same patient, 1st dose
Client received her 1st dose of COVID Pfizer vaccine at 17:14. After leaving vaccine site and sitting in her car for 5 minutes she returned to the vaccine site at 17:44 and communicated to the Ancillary Co-Lead that she was having trouble swallowing.  Ancillary Co-Lead sat client in a chair and requested EMT & Nurse assistance over the walkie-talkie at 17:45. Lead RN, Co-Lead RN, and EMT reached client at 17:47.  Client stated her throat was dry and she was having mild trouble swallowing.  EMT requested client to stick out her tongue.  EMT, Lead RN, and Co-Lead RN observed that client's tongue appeared white and chalky.  Client stated no SOB, trouble breathing, or any other symptoms.  Client stated she has no allergies and has never experienced passing out or any adverse reaction to a medicine or medical procedure.  Client was alert & oriented times 4.  Client stated that she started to have an odd feeling in her throat when she was sitting in the observation room, but did not think anything of it and left.  After getting in her car, client drank a  immunity booster shot, noticed trouble swallowing and came back to the site.  Client stated she was unsure if the immunity shot contained caffeine.  Client stated that she has a doctor she sees regularly, has no underlying medical conditions and takes no medications. Client also stated that she had a hysterectomy 6 months prior and could be experiencing surgical menopause.   Client indicated that she was nervous about getting vaccinated and felt anxious both before and after receiving the vaccine.  Tech brought client a bottle of water.  EMT proceeded to take client's vital signs at 17:55 as follows: BP:  146/88, HR:  75, O2:  99.   The client's friend who came to the site with her also walked up at that time.  Client communicated that she does not have high blood pressure.  Client requested more water and ended up drinking a total of 4.5 bottles.  Client stated that she had no dinner the night prior and only had a protein shake and small amount of soup today.  Client stated that she was starting to feel better and that her throat was just really dry.  EMT obtained 2nd set of vitals at 18:06 as follows:  BP:  142/80, HR:  98, O2:  99.  Client stated she was just feeling anxious about the incident, but feeling better overall.  Client stated she was swallowing OK.  Client stood up and stated that she felt OK.  Lead RN recommended client go to urgent care if swallowing issue returned and to call 911 if she experiences any SOB or trouble breathing.  Lead RN also communicated to client that she can follow up with her HCP and/or allergist for input on receiving 2nd shot of Pfizer vaccine.  Client left with her friend at 18:11 and was walking with a steady gait.
fatigue, tiredness, body aches, soreness at injection site, headache, loss of appetite, nausea first pregnancy, expected due date June 2023
Swollen, erythemic wheal >2 in. injection site with papular, blanching erythemic all over-body rash.
coughing, trouble breathing, fever, increased blood pressure. Patient taken by ambulance to emergency room.  no localized reaction at injection site.
Severe fever; severe body aches; headache; nausea; This is a spontaneous report from a non-contactable consumer (patient).  A 26-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported), via an unspecified route of administration, on 26Feb2021 (at the age of 26-years-old), at dose number unknown, single for covid-19 immunization. Medical history included postural orthostatic tachycardia syndrome (POTS), covid-19 and allergies to Ibuprofen and amoxicillin. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 since the vaccination. The patient experienced severe fever, severe body aches, headache, and nausea on 26Feb2021. The events resulted in doctor's office/urgent care. No treatment was administered for the events. The outcome of the event was recovered on an unspecified date in 2021.    No follow-up attempts are possible. No further information is expected.
Started with soreness distal to the injection site, approx 1/2 way down the upper arm, and it became hard, hot, red and inflamed.  Used an alcohol rub with some good effect.  Two days later the redness/heat/soreness spread to the ulnar region of the elbow with soft tissue swelling
Within 6 hours of the vaccine my face was swollen and drooping a bit. My face was hot and I felt like I had a severe ear ache. I went to urgent care next day and they put me on a 6 day steroid pack. She thought I had TMJ. Once I started the steroids' the symptoms went away, but when the steroids' were done the symptoms came back. I went to the doctor and she mentioned Bell's Palsy or TMJ. She put me on an anti inflammatory. The pain went away during the course of the medication. The next day the pain came back again. I went to my dentist in case it was TMJ and He did an x-ray and he stated I did not have TMJ and said I had bell's palsy. He gave me Celebrex and Flexeril. I took these medications for a week and slowly weaned off of it, but the symptoms went away and did not come back. After 10 months the symptoms came back. I saw my doctor and she gave me another steroid pack and the pain game back again. I told my doctor what the dentist had given me and she prescribed Celebrex and Flexeril. The symptoms have now gone away.
3-18-21 5:30PM PT STATES SHE FEELS'VERY HOT SINCE GETTING SHOT.'  FACE AND CHEST ARE FLUSHED. A/O, W/D, NO RESP DISTRESS. NO SOB OR DYSPNEA, NO PAIN, NO EDEMA OF THROAT/TONGUE. BOTTLE OF WATER GIVEN. 5:45PM  PT STATES SHE 'FEELS BETTER NOW'.  COLOR IMPROVED. 5:53 HUSBAND HERE TO DRIVE PT HOME.NO ACUTE OR OBVIOUS DISTRESS. 3-19-21 3:44PM TC: PT STATES 'HOT FLUSHED FEELING GONE NOW'.
Severe cold sweats that lasted 10 plus days. Had to change clothes constantly throughout the day and night and was extremely uncomfortable especially when air conditioning would turn on. Sweating was so bad that my entire bed and pillow would be wet and hair would be wet. It lasted like this for 10 days but continued on an off for almost 3 weeks. Injection site extremely tender for 14 days and still is slightly tender if touched in the spot where injected 40 days later.
101 temp at injection site; Tender arm to touch; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (101 temp at injection site), TENDERNESS (Tender arm to touch) and VACCINATION SITE PAIN (Pain at injection site) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE WARMTH (101 temp at injection site), TENDERNESS (Tender arm to touch) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, VACCINATION SITE WARMTH (101 temp at injection site), TENDERNESS (Tender arm to touch) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 101f (High) He put a themometer on the area and it read 101..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications reported.
Allergic reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) in a  patient of an unknown age and gender 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 HYPERSENSITIVITY (Allergic reaction). At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.
states had no symptoms for first 24 hours, then developed expected side effects including headache, body aches, fatigue. then on day 4 or day 5, states he developed problems with his equilibrium(falling into walls) but catches self and has not actually fallen to floor/ground.  states no really "dizziness, just problems with balance".   has not seen doctor or had any follow up.  states afraid of vaccine and will not receive dose 2.
5/6 16 hours after shot I started to get pain in my neck/head at the base of the skull on the right side. I rested but as the day progressed I couldn't turn my head without pain. I went to bed because my head was hurting. 5/7 I woke up not feel normal. My neck/head didn't hurt as bad. I almost felt like I had a hangover without drinking. As the day went on I started to get light headed and had to  call of work. 5/8 I woke up with the worst headache ever. The pain was back in my neck, my eyes were sensitive to light and everything was spinning. I slept a little more drank Gatorade to see if it helped but it didn't. I couldn't take it anymore so I went to the ER. After 9 hours waiting for test results I found out I have a vertebral artery dissection on the right side. I was admitted to the hospital for testing. 5/8 I was sent home with restrictions. I  am in the fitness field so I can't work or lift anything over 5 lbs.
chest pain 24 hours after vaccination with evidence of myocarditis by elevated troponins. Admitted for observation. echocardiogram was within normal limits. Tropinin downtrended over 24 hours and she was discharged home with outpatient cardiology follow-up to include a cardiac MRI and outpatient cardiology visit.
Nurse stated the dose was administered 12  hours after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse stated the dose was administered 12  hours after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021 at 10:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021 at 10:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse stated the dose was administered 12  hours after expiration date). On 15-Dec-2021 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (Nurse stated the dose was administered 12  hours after expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
Severe headache; Low grade fever; Vomiting; Joint pain; Chills; Sensitivity to light and sound; Sensitivity to light and sound; Dizziness; Shortness of breath; Booster (dose 3); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm left, administration date 13Dec2021 05:00 (Lot number: FH8030) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Postural orthostatic tachycardic syndrome" (unspecified if ongoing); "Peanut allergy" (unspecified if ongoing). Concomitant medication(s) included: AVIANE. Vaccination history included: BNT162B2 (dose 2, single; lot: EW0171; site: right arm; time: 10:00), administration date: 04May2021, when the patient was 29 years old, for COVID-19 immunization; BNT162B2 (dose 1, single; lot: ER8729; site: right arm; time: 10:00), administration date: 19Apr2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021 05:00, outcome "unknown", described as "Booster (dose 3)"; HEADACHE (non-serious) with onset 14Dec2021 13:00, outcome "recovering", described as "Severe headache"; PYREXIA (non-serious) with onset 14Dec2021 13:00, outcome "recovering", described as "Low grade fever"; VOMITING (non-serious) with onset 14Dec2021 13:00, outcome "recovering", described as "Vomiting"; ARTHRALGIA (non-serious) with onset 14Dec2021 13:00, outcome "recovering", described as "Joint pain"; CHILLS (non-serious) with onset 14Dec2021 13:00, outcome "recovering", described as "Chills"; PHOTOPHOBIA (non-serious), HYPERACUSIS (non-serious) all with onset 14Dec2021 13:00, outcome "recovering" and all described as "Sensitivity to light and sound"; DIZZINESS (non-serious) with onset 14Dec2021 13:00, outcome "recovering", described as "Dizziness"; DYSPNOEA (non-serious) with onset 14Dec2021 13:00, outcome "recovering", described as "Shortness of breath". Therapeutic measures were not taken as a result of headache, pyrexia, vomiting, arthralgia, chills, photophobia, hyperacusis, dizziness, dyspnoea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient had no history of COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Had MMR vaccine four times because she never developed immunity to it until the fourth round; Had MMR vaccine four times because she never developed immunity to it until the fourth round; This spontaneous report was received from a White female patient, who would be 32 years old at the reporting time and was also a midwife, via Pfizer. The patient was referring to herself. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On unknown dates, the patient was vaccinated with four doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis because she did not develop immunity until the fourth round (vaccination failure and extra dose administered).  The outcome of the event was unknown.  The causality assessment between the vaccination failure and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) was not provided.
nausea, diarrhea, generalized achiness, redness, pain and swelling at injections site all began 8/24/21.
TOOK FOURTH DOSE ON DAY 6; This spontaneous case report (PVX2019-2537) was received from a consumer on 14-Oct-2019. It described an 18-year-old male consumer who "took fourth dose on day 6" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever.  Case report: The consumer took first three doses of Vivotif according to schedule on day 1, 3, and 5 respectively however; he took the fourth dose one day 6.   Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took fourth dose on day 6" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took fourth dose on day 6" was considered as not applicable.
pt recvd vax; rash, itchy; joint pain & swelling, esp knees;seen in hosp 24sep94;tx w/ dph & prednisone; 25sep94 sxs subsiding;