chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 18-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old patient (gender unknown) who received injection of ACT-HIB lot UI799AA, expiry date 08 Jul 2018 via unknown route in unknown administration site on an unknown date. The patients past medical history, concomitant medication and family history were not provided. It was an actual medication error due to expired vaccine used. It was reported that the nurse gave a vaccine to a 12-month old that expired on July 8. The vaccine was administered yesterday. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
04/2021 Seen in ED for c/o left sided chest pain increased with deep inspiration. Blood work, chest a-ray and chest CT. DX with 2 blood clots left lung and pneumonia.  COVID test done - Negative.  Admitted to hospital and anticoagulated with Heparin. Numerous blood tests performed.  Followed by Hospitalist and seen by Pulmonologist and Hematologist.
Post-vaccine cellulitis left deltoid about 14-16 hrs after varicella and influenza to left deltoid. 14x15 cm. diameter. ? Just local reaction
Low grade fever ~100 degrees;  erythema extending in a 2 inch radius from injection site.; chills
This spontaneous report was received from a pharmacist referring to a male patient of unknown age. No concurrent condition or historical conditions were reported. On 07-DEC-2015, the patient was vaccinated with ZOSTAVAX (lot # and expiration date were not provided) 0.65 ml, subcutaneous (anatomical location was unknown). No concomitant medications were reported. On an unspecified date in December 2015 (also reported as "1-2 weeks" after receiving ZOSTAVAX) the patient experienced a rash on the back of his leg. At the time of the report, the outcome of rash was unknown. This is one of two cases received from the same reporter. Additional information has been requested.
Hard to breath, very bad chest pain and the worst head ache I?ve ever had. All symptoms went away in about 15 minutes.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 14-JUN-2016, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient. On or about 25-DEC-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of her injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not  limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Fever (101 degrees), headache, pain and swelling at injection site, nausea,
a couple hours after I got the vaccine, I have had some tingling in my left leg; It kind of looks like it is numb, but it is not, but it is like tingling; It kind of feels like needles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset 16Mar2021, outcome "unknown", described as "a couple hours after I got the vaccine, I have had some tingling in my left leg; It kind of looks like it is numb, but it is not, but it is like tingling; It kind of feels like needles".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Congestion, cough, sore throat, nasal drip, malaise, headache. Pt is planning to see his MD.
I have had my period twice in the three weeks after my first dose. The first was early on 30 April last for two days and the second beginning on 15 May for three days. This is a disruption in my period cycle and the symptoms I  have during my period are worse than usual - lethargy, abdominal pain.
Information has been received from a healthcare worker refers to unspecified patients of unknown age and gender. On 16-JAN-2015 the patients were vaccinated with improperly stored ROTATEQ (2 ml, once, oral, lot number was unknown). No adverse events was reported. Additional information has been requested.
5mins post vaccination pt reported dizziness Vitals: 97/64, 93, 16, 99% -- > 90/50, 90, 16, 100% -- > 90/55, 88, 16, 99% Pt was hydrated w/ water and had no further c/o dizziness Pt stable and released from the vaccination site.
No adverse events have been reported. This is vaccine error. Booster dose not recommended for 13 year and 7 month.
I have had a knot at vaccination site that became very itchy on day 8 post administration. Some arm tenderness returned also and slight tingling in thumb. No sign of infection, ie rash, redness or swelling
Chills, shivering, rapid heart rate, fever, headache, muscle aches 1:00 AM to 8:00 AM.
On Friday, February 26, I received my second dose of the COVID-19 Moderna vaccine. That same night, I started feeling soreness in the right shoulder, where I received the injection. The next afternoon, Saturday February 27, about 24 hours after I received the vaccine, I felt fatigued, but felt better after a 30-minute nap. On both of those days, I needed to put a cold ice pack on my sore shoulder. On Sunday morning, February 28, I noticed some redness on my right upper arm. The morning of March 1, I noticed that the area of redness was larger, measuring 4 inches wide by 6 inches long. On March 2, the redness was even larger, measuring 7 inches by 5-1/2 inches.
This spontaneous report was received from a medical assistant and refers to an adult patient of an unknown gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On 03-MAY-2018, the patient was inadvertently administered a dose of expired PROQUAD recombinant human albumin (rHA), lot # M039447 with an expiration date 20-MAR-2018, subcutaneously for prophylaxis (anatomical location were not reported). The sterile diluent used to reconstitute the Oka-Merck PROQUAD was not expired and there was no temperature excursion. No adverse effects were reported.
sore throat; he couldn't talk because he hurts.; fever; nausea; got deathly ill with headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), PAIN (he couldn't talk because he hurts.), HEADACHE (got deathly ill with headache), PYREXIA (fever) and NAUSEA (nausea) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced HEADACHE (got deathly ill with headache) and NAUSEA (nausea). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), PAIN (he couldn't talk because he hurts.) and PYREXIA (fever). At the time of the report, OROPHARYNGEAL PAIN (sore throat), PAIN (he couldn't talk because he hurts.), HEADACHE (got deathly ill with headache), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.
Pt experiencing and c/o left nasal burning, left upper lip tingling progressing to numbness with slight swelling noted, scattered patchy hives to upper front chest, sharp HA above right eye, denies SOB, no acute respiratory distress noted or reported, slurring of words shortly after onset of other symptoms. Pt repeating "something ain't right". Pt received Moderna COVID vaccine at 4:35pm with no reactions or side effect noted within the post 15 and 30 minutes. EMS notified at 5:49pm. MD notifed and ordered Benadryl 50mg IM (given at 5:53pm), EpiPen and DepoMedrol 40mg IM if needed. No respiratory distess noted, pt denies SOB. EMS arrived and transported pt to ER.
Nausea, fever, chills, body aches, headache, exhaustion, sweats.  Very significant symptoms.
Herpes Zoster aka Shingles; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCIN), via an unspecified route of administration, administered on the left arm on 31Mar2021 08:30 (Batch/Lot Number: ER8734) as unknown, single for covid-19 immunisation. Medical history included chronic migraine, wheat allergy and covid-19 prior to vaccination. No other vaccines were received in 4 weeks. Patient was not pregnant. The patient's concomitant medications were not reported.  The patient experienced herpes zoster aka shingles on 03Apr2021 08:00. Event resulted in healthcare professional office/ clinic visit. Unspecified antiviral was given as treatment. Outcome of the event was recovering. The event was considered non-serious by the reporter. Patient had not been tested post-vaccination.  No follow-up attempts are needed. No further information is expected.
do they hurt!! Worst shots I've ever had; This case was reported by a consumer via media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, refer case US2021AMR156322).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself/ herself. The age at vaccination was not reported. The patient received 2nd dose of Shingrix and experienced pain. The reporter stated that the patient might want to check to see if need a booster.  The patient reported that it was worst shot but better than getting shingles and it was a newer vaccine and was supposed to be much more effective than the previous shingles vaccine.  The reporter advised taking Tylenol or something like it before. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR156322:same reporter
Pt had developed fever 101.0 F on 3.30.12 after having KINRIX, MMR and VZV done on 3.28.12. Also, cellulitis on the left arm. Dr prescribed Amoxicillin 400 bid x 10 days.
Tiredness; muscle pain in legs; headache; extreme shivering; mild fever; unable to walk without assistance.
fever (3 days), headache (2-3 days), cough (6-7 days) unable to attend school (4 days)  Seen at the doctor on 12/7- tested for flu and COVID19, both were negative, believed to be a viral infection Seen at the doctor again on 12/10- diagnosed with an ear infection
This happened at both first and second vaccine - within a minute or 2 after each injection, i would get a flushing/hot flash feeling and then extreme anxiety that broke through all medication, even at increased dosages and lasted the 1st time until approx 4 days prior to second vaccine and at second vaccine is still ongoing now, along with a severe stiff neck on the opposite side of the vaccine arm as well as headache and fever (up to 102.6) ongoing now at 100.4 and hard lump at vaccine site
48 hours out from vaccine I experienced abrupt and intense depressive and anxious feelings including brain fog, dizziness and confusion. Dizziness and brain fog still persist 9 days out. Headache, lack of appetite and GI issues continue to persist.
Information has been received from a physician concerning a 23 year old male with no known allergies or medical history who in approximately 1986 (15 months old) and approximately 1995 (10 years old) was vaccinated with the first and second doses respectively of MMR II (dose and route not reported). There was no concomitant medication. On 06-JUN-2006, it was discovered that the patient had a negative measles titer. It became an issue when the patient applied to medical school. The patient did not seek medical attention. A product quality complaint was not involved. Additional information has been requested.
This case was reported by a consumer via sales representative and described the occurrence of vaccination failure in a female subject aged between 30 and 39 years old who was vaccinated with FLUARIX (manufacturer unspecified). A physician or other health care professional has not verified this report.  On an unspecified date the subject received a dose of influenza vaccine (unknown details). The specified date of vaccination was not reported; however, based on the date of the report, it was assumed that the vaccination was of the current influenza season. On 18 January 2014, less than one year after vaccination with influenza vaccine, the subject experienced vaccination failure and influenza infection. The subject wished to remain anonymous. At the time of reporting the outcome of the events were unspecified.
Injection site was red swollen and very sore.  Approx  7cm area.  Trouble breathing heavy chest
Admitted to hospital on 2/7 with shortness of breath. Had increased dyspnea, cough and congestion in the last week. Found to be COVID + with superimposed bacterial pneumonia causing acute hypoxic respiratory failure. Admitted and started on antibiotics with increasing O2 needs. Intubated on 2/14 but was later extubated on 2/19.  Chest x-ray continuing to worsen with acute renal failure. along with increasing O2 needs. Patient and family requested DNR on 2/24 .
chills; aches; headache; fever; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on an unknown date, did not had side effects).   On 28th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced chills, pain, headache and fever. On an unknown date, the outcome of the chills, pain, headache and fever were not recovered/not resolved.   It was unknown if the reporter considered the chills, pain, headache and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided. The age group was not reported but was selected as adult as per vaccine indication.  After second shot the patient experienced chills, aches, headache and fever. The reporter asked how long the events last.
This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL 9 (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccine was exposed to temperature of 23 centigrade degree (°C) to  1.9 °C range for an unknown time frame. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA000314:
This spontaneous report was received from a nurse practitioner concerning a female patient of unknown age. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unspecified date in 2018 (reported as "within the last 7 to 10 days"), the patient was vaccinated with GARDASIL 9, intramuscular for prevention of human papillomavirus infection (HPV) (dose, anatomical location, lot number and expiration date were not reported). On an unspecified date in 2018, the patient developed 5 quarter sized bruises distributed across her body, but none were at the injection site (contusion). The outcome of contusion and the causal relationship between the event and therapy with GARDASIL 9 were not reported.
Vaccine 3/2/2021.Presented to ER 3/25/2021 with chest pain and found to have acute MI with completely occluded left main coronary artery with clot causing cardiac arrest, cardiogenic shock. Currently Critically ill, intubated, high risk mortality.
c/o malaise 1 day p/vax;2 days later had T101.5, drowsiness, fatigue, too wick to get out of bed, extreme local redness, swelling @ site, per pt;to clinic 5 days p/vax entire rt arm red, deltoid area mod swollen;tx ice pack, DPH, APAP;
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 83-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (many times before). Previously administered products included flu vaccine, pneumonia vaccine and ZOSTAVAX. Concurrent medical conditions included macular degeneration, hypertension and diabetes. On 12th November 2018, the patient received the 1st dose of SHINGRIX. On 14th November 2018, less than a week after receiving SHINGRIX, the patient experienced feeling cold. In November 2018, the patient experienced injection site pain, injection site hemorrhage, injection site swelling, injection site bruising and shingles. In November 2018, the outcome of the injection site hemorrhage and injection site swelling were recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site bruising and shingles were not recovered/not resolved and the outcome of the feeling cold was recovered/resolved. It was unknown if the reporter considered the injection site pain, feeling cold, injection site hemorrhage, injection site swelling, injection site bruising and shingles to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on right arm. The patient reports that on 14th November 2018 and 15th November 2018, her body felt very cold and she could not get warm. The patient reports that she experienced soreness at the injection site and when she removed the bandage from the site, the site bled quite a bit. The patient states that she used ice at the injection site to help with the swelling that she experienced. The patient states that there was also bruising at the injection site. The patient states that she had a shingles rash on her buttocks. The patient had not been officially diagnosed with shingles by her physician, however, she states that she has had shingles many times and always gets it on her buttocks and she knows what the rash looks like. The reporter did not consent to follow up. The patient did not wish to provide her address or HCP information.
Hot, bruised, black and blue at injection site. Redness, warmth. Hard lumpy 6 days after shot. Knees ached, joint pain 24 hrs after dose  muscle pains
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 76-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. The patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 15-OCT-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (at the age of 69 years) (lot #, expiration date, dose and route of administration were not specified). On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
90 year old lady with hx of remote lung cancer s/p resection 2010, HTN, HLD presents for evaluation of chest heaviness x the past 2 nites. She denies shortness of breath, cough, fever ,chills, nausea or vomiting or syncope or any other complaints. It came and went. No precip factors. In the ED troponin is elevated, BNP is 1700 and Cr is 1.7-denies hx of renal disease, last noted Cr was normal. Chest xray showed pulmonary vascular congestion most likey consistant with heart failure. D Dimer is slighty elevated. Incidently rapid COVID swab was positive for COVID 19.
Left side breathing difficulty.  Painful to take a deep breath on left side only.  I?ve had pneumonia in the past and  painful on same side as vaccine.  Shortness of breath, winded when talking.
4 hospital visits in a two week period. Primary symptoms include syncope, seizure-like activity, chest pain, shortness of breath, vision disturbance - semi-conscious state lasts up to 1 1/2 hours. She has been evaluated at the clinic for for heart and brain abnormalities, so far all tests normal, blood tests normal, more neurology appointments this week. She had a GARDASIL injection in June 2011, and November 4 2011 - she also had a flu shot on Nov. 4th. Prior to these episodes she was a normal, healthy girl, no allergies or health issues.
This case involves a female patient of unknown age who got sick the last 8 years she took it (illness) when received vaccine INFLUENZA VACCINE. The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious got sick the last 8 years she took it (illness) (unknown latency) following the administration of INFLUENZA VACCINE. Laboratory details were not reported. It was not reported if the patient received a corrective treatment for the event. At the time of reporting, the outcome was unknown for the event (illness). The reporter assessed the causal relationship for the event (illness) with the INFLUENZA VACCINE as not reported. There will be no information available on the batch number for this case.
Pt developed 3cm X 2cm area of redness and heat with slight swelling in right deltoid.