chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had not had any spells of Afib prior to all this in 3 months or something like that. I took the shot and felt ok. Went through about 7 days and woke up around 3am with my heart out of rhythm. I took my pill and it did nothing for it, usually when I take the pill within an hour it controls my heart and puts it back in rhythm and gets my bp back. But this time it didn't, my heart rate kept going up and down. It took 5 hours for it to work but by that time it caused severe headache. I don't go through that kind of thing when it goes out of rhythm and usually when I take the pill within 1 hour it gets back and in 3 hours I'm just fine. And now I've been out of rhythm since that episode and this continues. When I was due to get the Booster I spoke to my Primary Doctor and she told me to take my Afib medication a day before and a day after the Booster shot. I did that even though it was not out of rhythm and the day after the shot and it didn't react as it did after the second shot. I had no aches and pains or temperature. It was a sudden going out of rhythm. I've been taking the Afib medication for 5 years and never had a severe reaction as I did after the 2nd dose vaccination. I went to my heart doctor and he said it's very possible it could be related to the vaccination. And he looked at my test results and said everything is fine now.
This spontaneous report was received from a physician via Pfizer refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with varicella virus vaccine live (manufacturer unknown) for prophylaxis (dosing details, lot/batch# not reported). On 06-JAN-2015, it was noted that, the patient experienced rash which was a drug hypersensitivity reaction. The outcome of rash and drug hypersensitivity was unknown. The reporter considered rash and drug hypersensitivity to be related to varicella virus vaccine live(manufacturer unknown). This is one of the two reports received from the same source.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6205), on 26Mar2021 as dose 2, single (Lot number: ER8727) and on 30Oct2021 as dose 3 (booster), single (Lot number: EW0185) for covid-19 immunisation. The patient's relevant medical history included: "Bicuspid aortic valve" (unspecified if ongoing), notes: Other medical history: Bicuspid aortic valve; "Beta blockers" (unspecified if ongoing), notes: Known allergies: Beta blockers. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 includes Paxlovid.   Clinical course:Patient felt better and was rapiding negative as of 07May22. On 11May22 (day 4 after Stopping paxlovid, and day 9 since I tested positive) patient developed a mild Sore throat, runny nose, and felt off. Patient took a rapid in the morning when she only had a mild sore throat and it was Negative. Patient then took a rapid around 3pm when her runny nose was more present and the rapid turned positive within a minute or two.Patient antiviral details include Covid 19 treatment which was started on 03May2022 and was stopped on 07May2022
Information has been received from the authors in a published literature article. OBJECTIVE: Limited data exist on human papillomavirus (HPV) vaccine (manufacturer unknown) safety during pregnancy. Although pregnancy is a contraindication, inadvertent vaccination does occur. Our objective was to evaluate whether HPV vaccination during pregnancy or periconception was associated with increased risks for adverse obstetric events, adverse birth outcomes or birth defects. STUDY DESIGN: We performed a retrospective, observational cohort study using administrative and healthcare data from the Vaccine Safety Datalink (VSD), a collaborative effort between the Centers for Disease Control and Prevention's Immunization Safety Office and several large health systems. The cohort consisted of insured women 11-27 years old with singleton pregnancies ending in a live birth from 01-JAN-2007 through 30-SEP-2013. Women receiving the quadrivalent HPV vaccine (4vHPV) vaccine (manufacturer unknown) during pregnancy or in the periconception period were classified as exposed. Controls were women with singleton pregnancies and a live birth during the same period who received 4vHPV 4-18 months prior to pregnancy start or last menstrual period (LMP). Risks of gestational diabetes, hypertensive disorders of pregnancy, chorioamnionitis, preterm birth (<37 weeks' gestation), small for gestational age (SGA) birth and major structural birth defects in offspring were evaluated. Using a generalized estimating equation method we evaluated adjusted relative risks associated with receipt of 4vHPV vaccine (manufacturer unknown) during pregnancy, the periconception period, and risks for both periods combined. RESULTS: We identified 720 women who received the 4vHPV vaccine periconception (Drug exposure before pregnancy) and 638 who received the vaccine during pregnancy (linked to MARRS# 1701USA010441), compared to 8196 with distal 4vHPV exposures. Vaccination with 4vHPV was not associated with an increased risk of adverse obstetric events, birth outcomes, or major structural birth defects during any of the exposure periods as compared to controls. CONCLUSION: In this cohort of insured adolescent and young adult women, inadvertent administration of the 4vHPV vaccine (manufacturer unknown) during pregnancy or periconception was not associated with adverse maternal or infant outcomes. This study provided needed data for providers and expectant mothers on the safety of 4vHPV vaccine, when inadvertently administered in pregnancy. This retrospective pregnancy report referred to 720 female patients (detail information as above). On unknown dates the patients were vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) (lot#, strength, dosage, frequency and route unspecified) for prophylaxis periconception. The last menstrual period (LMP) and estimated due date (EDD) were not known. The outcome of maternal exposure before pregnancy was reported as recovered/resolved (details as above). Additional information has been requested. Sender's Comments:  US-009507513-1701USA010441.
She got the vaccine, by 6:00 she started feeling very fatigued, body aches, chills. Took Ibuprofen and Tylenol. Then when she finally feeling the body aches improving and able to move around more she noted the loss of coordination on her left leg where she was not able to walk without assistance over 3 days time. The following Wednesday she had muscle spasms, her leg were jerk for no reason and not able to walk without somebody helping her.  She was admitted to the hospital and transferred to larger facility from 4/14/21 to 4/16/21  She was then referred to Neurology and symptoms improved, and improved for a week up until this past Sunday, 4/25/21, thought she was having a stroke, which they did not feel she was and left the hospital.   She then started loosing control of her left arm.   Not able to pick up a toy and move it from one place to the other.  Went to the ER, admitted her again and ran tests for a stroke, no blood blots, all blood work was normal.   She is walking with a cane right now so that she does not hurt herself.  Loss of muscle tone, and just being able to function normally in daily life which she was able to without any problems before the 2nd vaccine.   She is now being referred to a movement specialist to see if they can find out what is causing this issue.   In total she has been admitted for 6 days and 2 different hospitals.    1st admission was from 4/14/21 to 4/16/21. 2nd admission was from 4/28/21 to 4/30/21.
unable to obtain medical records from facility after several attempts; per death certificate pt died in the hospital with COVID 19 infection being a condition contributing to the causes of death;
Systemic: Dizziness / Lightheadness-Mild, Systemic: muscle spasm in lower back-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: a few minutes after receiving vaccination, patient reported painful back spasming, became flushed, dizzy
75-year-old woman admitted 1/9 with herpes zoster involving the right upper chest and neck, including the C3-C5 dermatomes. The vesicles began on 1/8. There are additional lesions on the left cheek and left lower abdomen, so this is clearly disseminated disease. Unclear if this was triggered by the Moderna booster, but the timing is concerning.  Status post the Moderna COVID-19 booster shot 1/7/22 (1 day prior to the onset of the Zoster).  Patient was hospitalized on 1/9/22 and is receiving acyclovir 10mg/kg IV every 8 hours for 7-10 days depending on her clinical response.
Complained of red dots all over - begun on her eyes and spread. Very itchy. Fever. Went to ED, started on Prednisone and Hydroxyzide. Pt called our office to advise of happening. Was not tolerating Prednisone. Told to lower to 2 tabs qd (Prednisone 10 mg). Pt agreed. 5/15/03 Pt doing better. Recovering well.
shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th May 2019, the patient received the 1st dose of Shingrix. On 16th May 2019, less than a day after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: In the evening after receiving a dose of Shingrix the patient saw the first signs of what he find out 5 days later was a case of shingles. This seemed like a very unlikely series of events. The patient visited the physician. The patient inquired whether it was possible to get shingles from the Shingrix.
MOM HAD A CONVERSATION ON 3/23/2006 WITH A FRIEND THAT HE HAD COMPLAINED IN THE LAST 2 WEEKS OF BODY ACHINESS, FATIGUE,  NUMBNESS, TINGLING IN HAND, LEG ON THE SAME SIDE.
Two days after the vaccine, I developed severe body aches and fever of 102.0 F. I had called my PCP and he directed me to go and get a COVID test which was negative. My symptoms went away after 4 days.
17 year old given Moderna vaccination. No signs and symptoms of adverse event during observation period of 15 minutes after injection.
Initial report was received from a health care professional on 22 August 2011. An 18 month-old female patient with a history of a cough "for a few days" prior to vaccination, had received on 17 August 2011 dose four intramuscular left thigh injection of PENTACEL, lot number C3930AA and a dose of Hep A (manufacturer, lot number, route and site of administration not reported). On 22 August 2011, the patient's cough worsened and she was taken to the ER (emergency room) where a nasal aspirate PCR test was performed with a positive result for Bordetella pertussis. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
After my booster on August 27, 2021, on September 7, I started falling and it got progressively worse. I could not feel from my hip to right under my knees bilaterally. I couldn?t walk. I had several series of falls. I couldn?t balance. My gait was extremely abnormal and I was finally hospitalized at a local HCF on September 27-30 as being unambulatory.  My calves hurt horribly but I could still feel them and I had pins  and needles in my feet. It was highly painful whenever someone touched them. I couldn?t straighten my legs and I couldn?t stand up or get out of bed without assistance.
Vx pushed back into the syringe barrel; Unaware how much of the vx was administered; This case was reported by a pharmacist via call center representative and described the occurrence of wrong injection technique in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number M397F, expiry date 23rd April 2023) and (batch number Z4J77, expiry date unknown) for prophylaxis.   On 15th February 2022, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On 15th February 2022, unknown after receiving Shingrix, the patient experienced wrong injection technique and incomplete dose administered. On an unknown date, the outcome of the wrong injection technique and incomplete dose administered were unknown.  Additional details were provided as follows: The reporter stated that, when she was administering 2nd dose of Shingrix to the patient in left deltoid, most of the vaccine was seen pushed back and being capture in the syringe barrel rather than going forward, which led to wrong injection technique and incomplete dose administered. The reporter was unaware how much of the vaccine was administered to the patient, if any. The reporter consented to follow up.
Patient developed an area of redness, swelling (6cm x 9cm), temp of 100.1 and pain at the injection site. Doctor advised applying Triamcinolone and Saran wrap to the area. Also try ice for 15 mins at a time.
Patient received vaccination, walked to waiting room.  His coworker stated about 5 minutes later he passed out in the chair and they helped him to floor.  His friend said his eyes rolled back and he started to shake.  He came back around 1 minute later.  His VSS, stated he felt dizzy but no other symptoms.
Information has been received from a physician's assistant concerning a 23 year old female who on 05-NOV-2007 was vaccinated with a third dose of Gardasil (lot# 659435/1265U). About ten minutes post-vaccination, the patient experienced loss of consciousness for about 15 seconds, felt dizzy, and when she came to consciousness she had a little twitch like a mini seizure. It was reported that the patient was not hospitailzed and no intervention was needed. Subsequently the patient recovered, three days later and was feeling fine. Upon internal review, mini seizure was determined to be an other important medical event. Additional information has been requested.
pt recv vax spotty erythema & itching;small vesicle @ inj site 2 days p/vax;
This spontaneous case reported by a consumer, describes the occurrence of illness (ill last week), upper abdominal pain (bad stomachache) and headache(s) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 15, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced illness (ill last week), upper abdominal pain (bad stomachache) and headache(s). At the time of the report, illness (ill last week), upper abdominal pain (bad stomachache) and headache(s) outcome: unknown. The patient was ill and had a bad stomachache last week (in Nov 2021). She also had headaches. The patient stated she was trying to get her booster shot. Concomitant medications and treatment information not provided.
inflammation in the injection site; pinkish discoloration around the circle; arm tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (inflammation in the injection site), VACCINATION SITE DISCOLOURATION (pinkish discoloration around the circle) and VACCINATION SITE PAIN (arm tenderness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included ACETYLSALICYLIC ACID (ECOTRIN) for Anticoagulant therapy, LISINOPRIL for Hypertension, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Skin disorder, FOLIC ACID for Vitamin B complex supplementation.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm tenderness). On 06-Feb-2021, the patient experienced VACCINATION SITE INFLAMMATION (inflammation in the injection site) and VACCINATION SITE DISCOLOURATION (pinkish discoloration around the circle). At the time of the report, VACCINATION SITE INFLAMMATION (inflammation in the injection site), VACCINATION SITE DISCOLOURATION (pinkish discoloration around the circle) and VACCINATION SITE PAIN (arm tenderness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
ON DAY 5 FOLLOWING HIS SECOND DOSE OF AVA PT EXPERIANCED CHEST PAIN, ELEVATED HEART RATE & BP ACCOMPANIED WITH BODY ACHES, HA, RESTLESSNESS & DIFFICULTY SLEEPING. HE HAD ALSO EXPERIANCED VERY SIMILAR SYMPTOMS ON DAY FIVE FOLLOWING HIS FIRT DOSE OF AVA. THE SYPMTOMS FOLLOWING THE SECOND DOSE WERE MUCH GREATER IN MAGNITUDE THAN THOSE FOLLOWING THE FIRST DOSE. ON 15 MAY 07 HE SOUGHT CARE WITH HIS PCM WHO CONFIRMED THE ELEVATED HEART RATE AND CHEST PAIN.
still experiencing arm soreness,; swollen; red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (still experiencing arm soreness,), PERIPHERAL SWELLING (swollen) and ERYTHEMA (red) 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 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (still experiencing arm soreness,), PERIPHERAL SWELLING (swollen) and ERYTHEMA (red). At the time of the report, PAIN IN EXTREMITY (still experiencing arm soreness,), PERIPHERAL SWELLING (swollen) and ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-069203, MOD21-069239 (E2B Linked Report).; Sender's Comments:  MOD21-069203: MOD21-069239:
****************COVID BREAKTHROUGH CASE*************** May18 - 19,2022 I had a very sore throat, coughing, heartburn, headache. I was told by my roommate that she had a positive COVID test so I went and tested on May 20th at Urgent Care Clinic and mine was positive as well.
I was experiencing headaches and body aches, I felt extra tired. I took it easy for a couple days. My blood pressure is higher than normal and I'm seeing a doctor on 11/05/2021. My blood pressure was around 149 and normally I'm in the 100-120 to 60-70. I'm not sure if its stress related.
Pt had a 27cm x 7 cm rash and had been complaining of pain. Rash was noted 6 days after administration when pt was seen back in clinic. Skin rash, rash and erythema, pain, warm to touch.
1) Extreme fatigue: started approx 24 hours after vaccine, still ongoing 48 hours after vaccine. no treatment. 2) Nausea:  started approx 24 hours after vaccine, still ongoing 48 hours after vaccine. no treatment. 3) Dizziness: started approx 36 hours after vaccine, still ongoing 48 hours after vaccine. no treatment. 4) Sinus congestion: started approx 24 hours after vaccine, still ongoing 48 hours after vaccine. Used saline nasal rinse, not very helpful. 5) Headache: started approx 24 hours after vaccine, still ongoing 48 hours after vaccine. Tried naproxen, not very helpful.
Pt recvd 2nd dose of MMR approx 1030AM on 2MAY92 p/getting into car, mom noticed pts head on chest, jerking movements in arms & legs, reported loss of consciousness approx 10 sec; pt was able to walk into house, but c/o h/a; was pale & hot
Initial report received from a healthcare professional on 18 March 2013. A 33-year-old female patient, whose medical history and concomitant medications were not reported, received a first intramuscular dose of ADACEL vaccine (Lot number: U4586AA and site of vaccination was not reported) on 18 March 2013. The patient was pregnant at the time of vaccination. Patient's last menstrual period date was on 28 July 2012 and estimated date of delivery was reported as 06 April 2013. The patient's health during pregnancy and risk factors was reported as "not applicable". At the time of this report, the patient had not experienced any adverse event. Documents held by sender: none.
Patient came to Pharmacy counter a few minutes after receive 2nd covid Imz.  Patient stated he felt very warm and like he may pass out.  Patient has had this happen with out vaccinations, thinks it may be a fear of the needle.  Ice Pack applied to Pt neck, given cold water and a fan provided.  Patient immediately felt better.  Had patient finish half a bottle of water and remain seated under direct observation for 10 mins.   Patient left with no problems and was doing fine when I called him several hours later.
This spontaneous report was received from a physician via company representative referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. Approximately 5 years ago the physician read in the media report that, on an unknown date, the patient was administered with GARDASIL 9 (dose, strength, lot number, expiry date, route of administration were unknown) or GARDASIL (dose, strength, lot number, expiry date, route of administration were unknown) for prophylaxis. On an unknown date, patient experienced an unspecified auto immune symptom or possibly guillain barre syndrome(guillain barre syndrome). Outcome and causality assessment were not provided by the reporter. No product quality complaint was filed by the reporter. Upon internal review, guillain barre syndrome was determined to be medically significant. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between GARDAIL 4 vaccine and/or GARDASIL 9 vaccine and the reported event of Guilllain-Barre syndrome cannot be established. Missing information includes: demographic details of the subject, date of vaccination (for all doses of vaccine), onset of the event, detailed clinical course, diagnostic work up (other causes ruled out), neurologist clinical evaluation and follow up. Company Comment- No changes to GARDASIL 4 vaccine and/or GARDASIL 9 vaccine product safety information are warranted at this time.  Merck and Co., Inc., continues to monitor the safety profile of GARDASIL 4 vaccine and/or GARDASIL 9 vaccine product.
Patient received a higher concentration dose of Pfizer COVID-19 Vaccine.  Dilution of vial was done with 1.3mL of NS.  Only this patient affected.  Rest of vial was discarded.  Patient did NOT experience any adverse S/S during 45-minute observation at field site.  No concern by Lead RN for release.  Patient verbalized feeling OK before release.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. Since an unknown date in November 2015, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (strength, dose, route, lot number and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.