chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (01035471). A contactable healthcare professional on behalf of a pharmacist reported similar events for 3 patients. This is 1st of three reports. A patient of unspecified age and gender started to receive PREVNAR 13, via an unspecified route of administration on Sep2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient developed severe injection site redness, rash, and soreness in 2018. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. Sender's Comments: Linked Report(s): US-PFIZER INC-2018525857 same reporter, drug, event, and different patient; US-PFIZER INC-2018525856 same reporter, drug, event, and different patient.
I noticed swollen lymph nodes under left armpit and breast. I had a mammogram but it was none cancerous. Also, having pain in my joints in my knees. Noticed shakes in my hands more.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Nov-2021 at 1:27 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 1:27 PM, the patient experienced PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Patient received vaccine which was stored in an ultra cold freezer at minus 82 degrees Fahrenheit. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported.  Treatment information was not provided.   This case was linked to MOD-2021-402935 (Patient Link).
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. It was reported that approximately in March 2013 the patient was vaccinated with the first dose of RECOMBIVAX HB (dose, route of administration, lot number and expiration date were not reported). The second dose of RECOMBIVAX HB was administered on 31-OCT-2013. It was reported that the patient was in the facility on 30-DEC-2014 (also reported as today), to receive the third dose of RECOMBIVAX HB. No adverse effects were reported. Additional information has been requested.
Patient experienced vasovagal reaction (dizzy, pale, blurred vision) without loss of consciousness within 2 minutes of receiving immunizations. Patient laid down on exam table with feet elevated, recovered in less than 5 minutes.
MD visit 6/7/99 acylovir 200/5 1/2 tsp x 5 days;atarax 10/5 3/4 tsp po q 6hr PRN;
heard of 4 or 5 people with heart attacks after the COVID-19 Vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heard of 4 or 5 people with heart attacks after the COVID-19 Vaccine".  Clinical course: The caller had heard of 4 or 5 people with heart attacks after the COVID-19 vaccine. The caller knew people who had heart attacks from the shot. Had heard several people with recent immunization, who got the shot and had heart attacks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Al started post shot 2 in mid-April 2021. Heart palpitations, felt like AFIB but wasn't. Bad fatigue for months. Wound up at a Cardiologist, Nephrologist and my primary Doctor. Had to wear a heart monitor for a few days. My heart beats feel different several times during the day and still do.
Menstrual period siezed the following month, came back the following month for 1 month, then seized again until date.
Patient developed rash, swollen arm. She saw her doctor, he gave Doxycycline 100mg for 14 days.
SHINGRIX was administered at Pharmacy on 6/1. By location of the reaction, and by pt report the area in which it was administered is in the posterior mid-third of the left arm. At this site, it would be a subcutaneous injection.
Patient received full Pfizer Pediatric vaccination series. (completed 11.29.21) Tested COVID positive on 12.21.2021 - significant illness - with fevers (going on five days now, cough, fatigue)
Morning after: Arm hurts to point can't lift, hands became blue and tinglingly, nausea, dizziness, body aches, fatigue, headache, chills, fever, and excessive sweating. The following morning: eyes are extremely puffy/swollen, entire orbital area hurts and vision is blurred!
My Psoriasis has been under control and I have had very little in the past year.  Since the shot it has come back and my at home treatments are not keeping it in control.  I will have to go back to having laser treatments.
Red rash around injection site Rt. thigh not raised. Pt acting fine otherwise. No tx needed. Where MMR was given in Rt. thigh.
Pts father tested positive for paralytic polio w/paralysis of both legs in NOV91; had onset of leg weakness on 23OCT91 & was hospitalized 24OCT91 undergoing extensive testing for leg weakness; stool culture grew polio virus, type 2;
flu like symptoms; Body aches; Headache; Chills; This case was reported by a other health professional via call center representative and described the occurrence of flu like symptoms in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA92AZ, expiry date 28th February 2022) for prophylaxis.   On 30th July 2020, the patient received Bexsero. In July 2020, less than a day after receiving Bexsero, the patient experienced flu like symptoms, general body pain, headache and chills. On an unknown date, the outcome of the flu like symptoms, general body pain, headache and chills were unknown.   It was unknown if the reporter considered the flu like symptoms, general body pain, headache and chills to be related to Bexsero.  Additional inforamtion was received as follows: The patient experienced body aches, headache, and chills after a dose of Bexsero. The Healthcare Professional  refered to the patients events as flu like symptoms. The events began the same evening the vaccine was received. No outcome of events was reported. HCP notesd there were multiple patients reporting "flu like symptoms" following doses of Bexsero. HCP could not provide these patients demographics, lot numbers, or expiration dates. Consent to follow-up was granted by the reporter. This case was linked to cases US2020158056, US2020158060, US2020AMR159262 by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020158056:same reporter US-GLAXOSMITHKLINE-US2020158060:same reporter US-GLAXOSMITHKLINE-US2020AMR159262:same reporter
Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is calling in to find out if he can take an allergy test on the same day as receiving his second shot of the Covid-19 Moderna Vaccine.  No concomitant medications were reported.  No treatment information was provided.
Pt developed a 1.5 to 2" diameter red, raised itchy area at injection site. Pt treated with Benadryl.
Information has been received from a registered nurse concerning a male patient who in 1997 was vaccinated with the first dose of MMR II. Subsequently the patient experienced a widespread rash and low-grade fever after the vaccination. Unspecified medical attention had been sought. The patient had recovered on an unspecified day. No further information is available.
Did not receive second dose; A spontaneous report was received from a consumer concerning a 74-year old female who received Moderna's COVID-19 vaccine (mRNA-1273), but did not receive second dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039K20A) in right arm for prophylaxis of COVID-19 infection.   On 08 Feb 2021, the patient reported they did not receive the second dose and 42 days have passed. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event did not receive second dose was considered resolved.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273. This case of inappropriate schedule of vaccination has no associated AEs.
This spontaneous report was received from a licensed practical nurse regarding a patient of unknown age and gender with no pertinent medical history reported. On 05-AUG-2009 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (dose and route not specified). On 05-MAY-2011 the patient was vaccinated with the second dose of GARDASIL (lot number and expiration date not reported) (dose and route not specified). On 12-AUG-2013 the patient was vaccinated with the third dose of GARDASIL (lot number and expiration date not reported) (dose and route not specified). The nurse reported that the patient was administered a fourth dose of GARDASIL (lot number and expiration date not reported) (dose and route not specified) by an unspecified physician. No adverse effect was reported. Additional information has been requested.
I had vaccination 8 days ago.  When I woke this morning, I had a little soreness in upper arm (where injection given), plus skin was very warm to touch.  About 3 hours later, a rash started to appear (splotchy red spots) and is still warm to touch.  Minor soreness.
Immediately after receiving the 1sy dose of the Moderna vaccine, patient lost consciousness for approx. 1 minute.  Code Blue activated, VS taken, and patient placed in a recumbent position.  After regaining consciousness, patient reported "ringing" in her ears and blurry vision.  PO fluids and snack encourgaed and tolerated well.  Patient refused hospitalization and on-site MD recommended for the patient to be sent home.
Very itchy, red, swollen, and sore arm with rash at injection site starting 8 days after shot. It feels like there is a hard bump under my skin at the injection site.
This spontaneous report was received from health care professional regarding unspecified patients of unknown demographics. There was no information regarding concurrent condition and historical medication. On unspecified dates between 01-NOV-2014 and 13-MAR-2015, patients received improperly stored PROQUAD (Merck) (dose strength and route was unknown). No adverse effect was reported. No concomitant medication was reported. No Product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 02-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2108USA000999: US-009507513-2108USA000995: US-009507513-2108USA000996: US-009507513-2108USA000997: US-009507513-2108USA000998: US-009507513-2108USA001006: US-009507513-2108USA001005: US-009507513-2108USA001004: US-009507513-2108USA001003: US-009507513-2108USA001002: US-009507513-2108USA001001: US-009507513-2108USA001000: US-009507513-2108USA000973:
Initial information received on 08-Jan-2019 regarding an unsolicited valid non-serious case received from Other health care professional (PA). This case involves a 39 years old female patient who received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, concomitant medication and family history were not provided. On 08-Jan-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT5911JA, expiry date 30-Jun-2018 via intramuscular route in the left deltoid. It was an actual medication error due to expired vaccine used. 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.
They both received the GARDASIL 9 vaccine as adolescents. As adults, they both had trouble conceiving; Eventually they both were able to conceive and did have children; This spontaneous retrospective pregnancy report was received from a registered nurse via field representative and refers to adult female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date (when the patient was adolescent), she was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) indication reported as vaccine.  On an unknown date (when the patient was adult), she had trouble conceiving. Eventually the patient became pregnant. Date of last menstrual period (LMP) and estimated due date (EDD) were unknown. The pregnancy outcome was live birth (as it was reported that the patient eventually did have child). It was unknown whether the patient received any treatment. The outcome of the event was unknown.   The causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the event was not reported.  This is one of two reports received from the same reporter.
Mother states that pt started running a fever and crying inconsolable for long periods of time then he would nap about 45 minutes at a time and this lasted through the evening. TYLENOL was given every 4 hours. When child woke up this morning he could not keep his balance when he tried to walk. This lasted about 1 hour. Mother took child to PMD.
other zoster related injuries; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 01-MAY-2010, the pt was administered zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions, by a physician. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by the physician and other healthcare providers for shingles and other zoster related injuries. At the time of the report, the outcome of the events of shingles and other zoster-related injuries was unknown. The reporter considered both events to be related to zoster vaccine live (ZOSTAVAX).
This patient's father reports onset of fever between 10 AM - 11 AM this morning. He also reports vomiting 3 times, fatigue, malaise, and a stomach ache. The patient temperature was not measured. The nurse consulted the physician and advised the family to monitor his sickness. Seek medical care if fever increases of sickness continues or worsens.
The day after the immunization was administered, the patient developed a 7.5 cm x 5 cm area of cellulitis. He was started on antibiotics (KEFLEX) afebrile. (L) arm
I tested positive for COVID-19 on 12/3/22. I had a headache, cough, congestion, and a low-grade fever. I contacted my doctor and was prescribed 5 days' worth of PAXLOVID. I started feeling better after taking PAXLOVID. My symptoms lasted for about 6 days.
Vaccine administered on 10/7/08.  Allergic RTN started 10/9/08 with hives on arms, neck, trunk of body, progessed on 10/10 to swollen face , eye and troat.  Patient was referred to urgent care/ER  MD.
A 5 year old male was vaccinated on27-AUG-2001 at 9:20 AM with MMR (second generation) SC in the LA. Concomitant vaccinations that same day and time included the first dose of Varivax SC in the LA, the seventh dose of Tripedia IM in the LA and the sixth dose of IPV SC in the LA. There was no illness at the time of vaccination. On 27-AUG-2001 at 10:15 AM the pt's mother called the physician's office and informed them that the pt experienced difficulty breathing, a red "slap like" rash all over with extreme itching. The mother was instructed to go to the doctor or ER. The pt's mother called later in the afternoon to report an ER visit. the pt received prednisone, Prelone times 3 days and Benadryl. It was unknown if the pt recovered. This was originally reported by a nurse. Upon internal review, the pt's difficulty breathing was determined to be an other important medical event. Additional information has been requested.
Lots of swelling in all joints accompained with pain in all joints, swollen lymph node. On 10/21/2015 (6 days later) only mild joint pain remains.
This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with second dose of GARDASIL (dose and frequency were not reported) at the age of 18. On an unknown date, the patient received the third dose of GARDASIL (dose and frequency were not reported) at the age of 19. No other additional information was available. Additional information has been requested.
This spontaneous report was received from a healthcare professional regarding unspecified number of patients of unknown age and gender. On an unknown date the patients received improperly stored doses of PROQUAD (lot# M017334 expiry: 05-OCT-2017) (data digital logger). No adverse effects were reported. The vaccines were exposed to a temperature of 5.4 degree C for 3 hours and 53 minutes. There was no previous exposure reported. This is 1 of 2 reports from the same reporter. Additional information has been requested.
pt recvd vax; sore throat, fever 102 x 4 days; chills, aches, ha; events lasted x 3 wks;bed rest, fluids, vitamin C daily
Patient was supposed to receive a TB shot and was given fluzone quadrivalent instead; Initial information received on 17-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient of an unknown demographics who received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED instead of TUBERCULIN TEST [TUBERCULIN PPD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UI998AD, expiry date: 30-JUL-2019 via intradermal route in unknown administration site.  It was a case of actual medication error due to wrong vaccine administered.  Patient was supposed to receive a TB shot and was given fluzone quadrivalent instead. a patient that was given a flu shot Intradermal versus Intramuscular.  It was unknown whether the patient had any adverse event.  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 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.  Documents held by sender: none.
Swelling at injection site, warm to touch, used cold compress and went down, swollen pouch at bottom elbow two days after injection.
fever of 101, diarrhea, aches, chills, delirium because of fever, excessive fatigue
Day 1 Approximately 13 hours after injection. Started out with chills and low fever of 99.5F. Fever steadily increased over 12 hours to 101.9F. Had body aches, headache and low energy. Appetite was fine. No stomach issues. After 12 hours fever started to go back down. Fever broke approximately 18 hours after onset of adverse symptoms. Took acetaminophen every 4 hours until max dosage of 10 tablets per 24hour period.    Day 2 Headache and low energy. Diarrhea started approximately 32 hours after initial adverse symptoms. Drank lots of fluids. Small rash broke out on back (both sides near rib cage) that was itchy but did not hurt. Took Benadryl for rash symptoms and acetaminophen for headache. All symptoms had cleared by next morning.