chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1. Menstrual started 2 weeks earlier 2.. Cramps 3. Stomach pain I have not went to be treated. I am still going through the pain.
Arthus reaction to PPSV23 injection. SOB, temp at 101 down to 99 on 8/20/14. Two extra strength Tylenol and two OTC ibuprofen to treat fever. Best if body fights the reaction. Problem was administration: Medical assistant came into room with uncapped needles for myself and mother. She administered the vaccine so fast before I could realize that she did not swab the area prior to administering vaccine.  Reported to clinic the issue but they did not offer to see me.
INITIALLY ITCHING RASH ON BACK AND SCALP. SUBSEQUENTLY ALSO APPEARED  ON TORSO, STOMACH, ARMS, THIGHS..
Couldn't focus that well; Arm is a little tender; Wasn't feeling well; Feverish; Tired; Chils; This spontaneous case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (Couldn't focus that well), PAIN IN EXTREMITY (Arm is a little tender), MALAISE (Wasn't feeling well), PYREXIA (Feverish) and FATIGUE (Tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced DISTURBANCE IN ATTENTION (Couldn't focus that well), PAIN IN EXTREMITY (Arm is a little tender), MALAISE (Wasn't feeling well), PYREXIA (Feverish), FATIGUE (Tired) and CHILLS (Chils). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) on 14-Mar-2021 for Pain in arm, at an unspecified dose and frequency. On 15-Mar-2021, DISTURBANCE IN ATTENTION (Couldn't focus that well), MALAISE (Wasn't feeling well), PYREXIA (Feverish), FATIGUE (Tired) and CHILLS (Chils) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm is a little tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.
patient can't get his second dose yet, received first dose 6 weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient can't get his second dose yet, received first dose 6 weeks ago) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for an unknown indication.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient can't get his second dose yet, received first dose 6 weeks ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient can't get his second dose yet, received first dose 6 weeks ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication was reported.  Patient gave his consent for safety to Follow-up
Extreme chills with fever, stiffness and body pain through whole body, headache, nausea,  extreme tiredness lasted 36 hours.  Improving by 48 hours but still experiencing same symptoms but the severity has reduced.
Employee developed pruritis and widespread hives over the trunk of his body including upper thighs, lower abdomen and buttocks after flu vaccination on 10/18/19.  He did not have any other systemic symptoms.  He alerted his primary care provider and took 50 mg of Benadryl to treat the pruritis.  The hives lasted for 48 hours and all symptoms resolved on 10/20/19.
Patient reported intitially on 09-08-19 that she had a lot of pain/swelling on the "inside" of the arm where she had the vaccinations. She also reported the area was hot to the touch. When questioned if it was on the outside of the arm where the needle went in she said,"no, on the inside of the arm"  She called back later stating that she sees the issue on the outside of the arm, as well.
17MAR94 inc fever 102 listless constant crying; 22MAR94 constant crying, loss of papetite-sleeping alot; fever; 25MAR94 seen by MD inc fever given APAP; 26MAR94 dec fever, listless; 27MAR94 appetite slowly returning;
One the third day is had an upset stomach. Then the next week, I started to feel tired but then I started having a very weird heartbeat that kept me awake at week (during the day they came and made me feel super dehydrated).
Fever started that evening with chills and shaking. Fever of 101 degrees lasted for at least 24 hours. Also body aches.
pt recv vax 20NOV95 & 21NOV95 pt devel a low grade fever along w/local redness & tenderness @ the lt deltoid;tx w/APAP & the fever resolved w/in 12hr;the redness & tenderness resolved on 22NOV95;
passed out; chills; difficulty sleeping; nausea; hit head; redness at injection site; swelling at injection site; hot at injection site; hard at injection site; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th August 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site induration. On 14th August 2019, the patient experienced passed out (serious criteria GSK medically significant), chills, difficulty sleeping, nausea and head injury. On an unknown date, the outcome of the passed out, injection site erythema, injection site swelling, injection site warmth and injection site induration were not recovered/not resolved and the outcome of the chills, difficulty sleeping and nausea were recovered/resolved and the outcome of the head injury was unknown.   It was unknown if the reporter considered the passed out, injection site erythema, injection site swelling, injection site warmth, injection site induration, chills, difficulty sleeping, nausea and head injury to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. One day after vaccination, the patient experienced passed out and hit head, chills, difficulty sleeping and nausea. The patient planned to continue follow-up with her physician specifically for the reason of passed out. The reporter consented to follow up. No further information was provided.
2" x 2" hot, red to touch localized area of injection since 7/29/15 AM. Pt feels nausea and frontal headaches and feels "sick to her stomach". Muscle aches.
Immediate sign was a headache dizziness and high fever at 10:55 AM at around 11:10 AM severe dizziness complaint of head hurting badly and inability to walk straight (i.e. walking like a drunk person) only taking about 3 steps this was about 11:15ish he blacked out and went down luckily I caught him before he hit anything and I put him in a chair when I put him in the chair he went into full convulsions and had a seizure of which he has never had before. I took him to hospital ER they did a CT scan and blood work both of which came back Normal. Then we got transferred to another Hospital where Dr. saw him I believe we arrived at 5:40ish and did not leave until around 1:00 AM.
This spontaneous report as received from a health professional (registered nurse) refers to a patient of unknown age who was administered two doses of RECOMBIVAX HB (to equal one adult dose) (5 mcg/0.5 ml), intramuscular (lot # not reported) on 28-AUg-2012 for the first dose in the series, then only one pediatric dose of RECOMBIVAX HB (5 mcg/0.5 ml), intramuscular (lot # not reported) on 31-OCT-2012 for the second dose in the series, and then two pediatric doses of RECOMBIVAX HB (to equal one adult dose) (5 mcg/0.5 ml), intramuscular (lot # not reported) on 11-MAR-2013 for the third dose in the series. No adverse effect reported. Additional information has been requested.
Slept 20 hours straight Friday 10-24 then hives on face, neck, arms on Saturday & Sunday, mild asthma on Saturday & Sunday, large hot knot at injection site and that arm swollen, severe hives in mouth (blisters and sores on tongue and gums, and cheeks and throat.
Two hours after receiving Pneumovax, patient noticed pain around injection site.  Pain gradually increased.  24 hrs later, she had 10x20 cm area of warmth, redness and tenderness. She could not abduct or posteriorly rotate shoulder due to 7/10 pain.  C/o myalgias, no fever, no respiratory symptoms.  Patient prescribed Allegra 180 mg po daily and ibuprofen for pain and inflammation; to apply ice pack and return if symptoms continued or worsened; to seek emergency medical assistance if any sign of systemic or respiratory symptoms.
+local rxn of erythema & swelling 5cm x 3cm 48hr;+ system reaction nausea/vomit 48hr;
Tests positive for covid approximately 7 months following full vaccination; Tests positive for covid approximately 7 months following full vaccination; Cough; Fever; Chills; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single; received dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient tests positive for covid approximately 7 months following full vaccination and had cough, fever and chills. It was reported that patient was currently quarantined. The patient underwent lab tests and procedures which included sars-cov-2 test (covid) and showed results Positive on an unknown date in 2021. At the time of this report, the outcome of events was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Went to the ED as directed by his PCP Started to have chest ache/  Reports Dull ache right side mid chest. Light ache all the time, and with deep breathing has a sharper pain lasting only a few seconds. Denies difficulty with breathing.  He is breathing more shallow to avoid increased pain.  Feels like when he had broken ribs before. Right shoulder tender at the vaccination site, denies redness or swelling. Also received a flu vaccine that day
I returned from a trip to help family.  Arrived via plane on Sunday August 1, 2021. On August 2 I had a sore throat and by the following day I had a fever of 99.9 and requested a COVID test to be sure I did not have COVID.  The test was provided by pharmacy on August 6, 2021 and I had a negative result.  For 7-10 days I had slight congestion but fever disappeared by  August 4.   I was asked to provide this information to the CDC.
Muscle spasms, nausea and severe chills, headache - per patient symptoms lasted 2 days and required rest.
He became very dizzy and nauseous.  Felt like he had to vomit but did not. Was sweaty and pale.  He then told me he had had a similer reaction to a flu shot . (did not indicate this on consent form) Offered to help him lie down but at first refused and held garbage can. got him a cold pack and convinced him to lie down. he did for just a few minutes, then sat up and said he felt much better.   I talked to him and he was always coherent and aware of what was going on.  The 15 minute timer went off while he was sitting on the floor and wanted to get back into chair. and color returned to normal.  A friend was with him in store, he called her to come to the pharmacy area. Ther sat for a while, I talked to them and since he seemed steady on his feet, the left together .Total  time was 25-30 minutes
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.  A female patient received BNT162b2 (BNT162B2), as dose 2, 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), for Covid-19 immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a registered nurse concerning a 66 year old female with no known medical history or allergies who on 9/11/06 was vaccinated SC with a 0.5ml dose of varicella zoster virus live (lot 652965/0622F. It was reported that the pt was vaccinated because she had a strong family history of shingles. There was no concomitant medication. On 9/13/06 the pt developed a rash at the injection site and on other body areas. She went to the ER to be treated and was place on Valtrex. Additional information from the registered nurse indicated that the pt told the ER that she had shingles and that her shingles might get worse. She was given a prescription, but the pt didn't know if she was going to take it. She thought she would try BeBaum for the rash instead. The pt cancelled her appointment for follow up. The nurse reported that the pt had a minor case and was walking and talking fine. At the time of the report, the pt was recovering. Additional information has been requested. It was reported that the patient had a chickenpox as a child. There was no recent exposure to chickenpox or herpes zoster noted.  Additional information indicated on 09/14/06 (also reported as 09/13/06) in the evening the patient developed a rash, went to the ER and was diagnosed with shingles treated with  valacyclovir hydrochloride (VALTREX). The nurse reported the patient had a follow-up appointment and was a "no-show". Multiple phone attempts were made and the nurse was unable to reach the patient, therefore no resolution was obtained. No further information is expected.
Report 20010027841 describes acute viral myocarditis and diffuse brain swelling in an 11 month old male. This report was received from an attorney, and the attorney's "medical expert", and has not been verified by a physician or other health professional. The vaccinee and his family had no history of drug allergies or vaccine reactions. The vaccinee was healthy with no prior or current illness. He was taking no medications except for the vaccines listed below. On 04/05/1999, the vaccinee received vaccinations of IPV OPV, and Hib (reportedly non-Smithkline Beecham products) in addition to Infanrix. On 04/05/1999, the vaccinee received the unspecified dose of Infanrix. At an unspecified time thereafter, the vaccinee developed flu-like symptoms (nos). His symptoms worsened, and he was transported to the hospital on 04/11/1999. During transport, the vaccine "coded" and could not be resuscitated. He was pronounced dead on arrival at the hospital. An autopsy revealed acute myocarditis and diffuse brain swelling. Reportedly, post-mortem viral titers were "uninformative" (nos). The reporter indicated that he believed that the events were most likely related to the OPV / IPV vaccinations, and not to Infanrix. Cause of death given as acute viral myocarditis. Also, there was brain swelling.
Transient elevation in blood liver enzymes,The effect could result from the disease condition; This spontaneous case was reported by an other health care professional and describes the occurrence of CONDITION AGGRAVATED (Transient elevation in blood liver enzymes,The effect could result from the disease condition) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 41L20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (Transient elevation in blood liver enzymes,The effect could result from the disease condition). At the time of the report, CONDITION AGGRAVATED (Transient elevation in blood liver enzymes,The effect could result from the disease condition) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Aspartate aminotransferase increased: High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  No treatment medication were reported.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Mild
This spontaneous report as received from a other health professional refers to 15 patients of unknown age. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M043731 for prophylaxis. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to GARDASIL 9. The reporter considered no adverse event to be not related to GARDASIL 9. Additional information has been requested.; Sender's Comments: US-009507513-1708USA005788:
Since the vaccine my period has become MUCH heavier.  It is completely different now. I bleed through a whole box of tampons and pads. This has never happened my whole life
Initial information received on 05-Feb-2019 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2019SA036637 (same reporter). This case involves a seven years old patient who was vaccinated with a dose of DAPTACEL (lot number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported seven years patient received TDaP. It was unknown whether patient experienced any adverse reaction. 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 Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient presented on 16Aug06 with c/o pain all over. Rectal temp 105. Wheezing with inhalation noted. Reported to HCWs that had cessation of perspiration early in the day. Labwork completed. Given 2L of NS. Nebulizer given and transferred to ER. Hospital admitted patient for observation with diagnoses of smallpox vaccination reaction as well as heat exhaustion. 09/06/06-Facility and clinic records received for DOS 8/16-8/21/06. Seen in ER at Medical Center and transferred to another ER with c/o febrile reaction presumably due to small pox reaction as well as heat exhaustion. Initial temp 105 (patient stated he ceased perspiring) after 2L saline temp 103.9-admitted for observation. No chest pain no SOB, wheezing RX with Nebulized Albuterol. PE revealed a well healed tattoo on left forearm within center a large raised erythematous lesion with mildly necrotic center and small vesicles noted through the circumference of this region.  Assessment: Fever and dehydration UA moderate occult blood and trace ketones Follow-up visit in clinic on 8/18/06-C/O headache, intermittent cough, generalized aches and pains, sudden onset swelling upper lip while sitting in clinic.  Allergic to Penicillin PE:WNL with mild wheezing unilaterally on left at apex DX sinusitis allergic reaction  myalgia and myositis Follow up visit 8/21/06-"feeling good and ready to work: IMP: convalesced from heat injury-no relationship (except coincidental) with smallpox vaccinations. Plan: returns to duty, care with hydration.
Patient returned 2 days after vaccination and showed arm to pharmacist. Swollen spot of 2-3 inches across visible. Redness and warmth felt.
pt recv vax 25JUL96 & 21AUG96 pt exp malaise & devel a varicella-like rash w/approx 12 vesicles on flank, torso & arms;By 22AUG96 pt recovered from malaise;
Generalized urticarial; Generalized pruritus with skin rash; Generalized pruritus with skin rash; Generalized erythema; Hives were located on my chest and neck/Hives on anterior chest, neck and jaw line; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm, administration date 13Jan2021 (Lot number: EL3248) at the age of 38 years as dose 1, single and administered in arm, administration date 03Feb2021 (Lot number: EL1283) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes; "allergy: Medication" (unspecified if ongoing), notes: Does the patient have a history of any previous allergies to specific products or any condition indicative of an allergy: Medication. There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset 16Jan2021, outcome "recovering", described as "Hives were located on my chest and neck/Hives on anterior chest, neck and jaw line"; URTICARIA (non-serious), outcome "recovering", described as "Generalized urticarial"; PRURITUS (non-serious), RASH (non-serious), outcome "unknown" and all described as "Generalized pruritus with skin rash"; ERYTHEMA (non-serious), outcome "unknown", described as "Generalized erythema". Therapeutic measures were taken as a result of urticaria, urticaria.  Additional information: Both shots I had hives for 2-3 weeks after. Hives were located on my chest and neck. Hives would come and disappear, then come back again. Prior to vaccination, patient was not diagnosed with COVID-19 and Since the vaccination, has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
SHINGRIX injection was given Sub-Q instead of IM. Patient had redness in left elbow 2 days later-No issue at injection site.
axillary temp to 103 w/lethargy & listlessness x 12 hrs;