chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.).    No concomitant medication was provided by reporter. No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697687:Master case
This spontaneous report as received from a physician refers to a 15 years old male patient with no medical history. The patient was vaccinated IM with a shot of GARDASIL (unspecified whether this was the first, second or third shot in the series, dose and lot # unknown) on 10-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. In the evening of 10-SEP-2012, he had a fever of 99 degrees. He appeared to be confused and was sleep walking. The patient was seen in the office in the morning of 11-SEP-2012 and was treated with MOTRIN and TYLENOL. At this time, the physician noticed seizure like movements of the patient's arms. AEs were considered to be significantly disabling by the reporter. Test for influenza and other neurological test were run (unspecified). AE had improved but it was unknown if therapy was discontinued or not. Additional information has been requested.
This spontaneous report as received from a nurse practitioner refers to a 51 year old male patient. The patient had no pertinent medical history. The reporter reported that "about 25 years ago" (approximately in 1989) the patient experienced hives with use of Penicillin. On 13-OCT-2014 the patient was vaccinated with ZOSTAVAX via (dose and route were not reported) (lot # K007986, expired date: 03-SEP-2014). Concomitant therapy included NEXIUM. The patient began to experience redness at the injection site with 12 hours of receiving the vaccine (approximately on 13-OCT-2014). The patient sought medical attention by presenting to the nurse's office that morning with an oval shaped, raised, reddened area around the injection site. No rash presented. The reporter reported that there was "a dark red inner area with a diameter that measured 2.5 cm by 5 cm and a faint red outer ring with a diameter that measured 5cm by 9cm". No treatment was given for adverse event. No lab diagnostics studies were performed. The patient was not recovered from adverse event. The reporter did not assess the causality between adverse event and ZOSTAVAX. Additional information has been requested.
Severe headache lasted first and second day after vaccination not relieved by Tylenol or ibuprofen
I was expected to start my period on or around January 16. Today is February 10th and I still have not started. I have taken two pregnancy tests both after my missed period date and both were negative.
Information has been received from a health professional concerning a 6 year old black female who on 06 APR 2001 was vaccinated SQ in the left arm with a second dose of varicella virus vaccine live (Lot #637671/1609K). On 13 APR 2001, the patient developed typical varicella lesions. Additional information has been requested.
Pt received her 2nd Moderna covid 19 vaccination on 3/10/2021 and the following day woke up severely weak  with chills, fever, vomiting and diarrhea and headache  and was found on the floor by family at 2:30 pm. She reported she was so weak she lowered herself to the floor around 7:30and lie there till she was found in the afternoon.  She was given IVF and admitted  to the hospital for further work up  and physical therapy.
Localized redness and swelling, heat with Atarax 10mg TOD and Keflex 20 - BID x 10 days.
The school nurse had just finished giving this student the Menactra and HPV vaccines and the student slumped over, her body began shaking and began having "seizure like" activity of her body shaking, teeth clenched, for 45 seconds.  She did not remember any of the incident.  She then woke up.  The student complained of a headache and stomach ache after the incident.
L upper arm pain. Patient claims that the pain in his upper arm has not gone away since the  immunization.
I received my vaccine on 1/8/2021 in the afternoon a few hours later I got a severe headache that was so bad I had difficulty seeing, it really felt like I got Covid again.  I had 12 visits to the ER and 2 admissions beginning on March 3/2021 and May 17, 2021, for various reasons included; severe headaches, loss of vision, pain in ears and spine, tingling in arms and legs, memory loss, fogginess, seizures.  It felt like my whole body was on fire. I think they did a Covid test on my 4th or 5th visit to the ED and it was negative. Sever depression to where i wanted to hurt myself. That has gotten better with medications. I am working minimal hours because you are on reduced schedule due to symptoms.
Narrative:  COVID infection following COVID vaccine series 03/16, Pfizer, dose #1 04/07, Pfizer, dose #2 11/09 COVID swab, result: detected 10/30 pt cc: cough, loss of taste or smell, myalgias, rhinorrhea, exposure: unknown 11/10 clinically resolved
Client had Flu imm. on 10/5/18 with subsequent cont. achy/sharp (L) shoulder pain, currently rated 5/10 with movement of shoulder and with sleeping. Denies N/T/LOP but did have upper arm pain. Rx with ice without relief. Client is (R) handed. Pain with Abduction and arm crossing over chest. No prior shoulder inj. DO.
Flu shot - Friday am arm was red and swollen by Sat PM. Went to urgent care on Sun AM. Arm was swelling from shoulder to elbow. Patient was given TYLENOL and BENADRYL. Allergy doctor is following up: possible allergy to vaccine.
Beginning within 24hrs past second dose on 10/14/21, severe physical exhaustion that improved roughly 72 hours later. Post 72 hours dramatic decline in physical performance that has persisted through current date, 02/2022. Pre-vaccine, long distance runner comfortably running 20+ miles at once. Post- vaccine, struggle to run 5+ miles. Have run 10+ miles once since vaccine and experienced exhaustion early in the activity that remained throughout. Performance stats demonstrate slower speeds and working harder. Reporting as an adverse event here because it has felt like a continuation of the immediate post- vaccine exhaustion that I've been waiting to improve. Nothing I've done has seemed to improve it.
Vaccinated with H1N1 on 12/07/2009, 24 hours later, on 12/08/09 I had chills and fever up to 102 degrees F. This hovered from 102 degrees F to 101.4 degrees for 5 days. No appetite, and just slept a lot day and night. Today 12/18.09, I still do not have my energy back. Still recovering
Patient developed burning pain on right side of neck which spread from rear to the front.  Symptoms started two days after receiving anthrax shot in left arm.  Diagnosed with a case of shingles.  One blister broke out on right earlobe 5 days after recievng vaccination.  Pain, headaches, and occasional earaches continue to occur almost two weeks after vaccination.  Patient trated with antibiotics, antiviral drugs, and Motrin.
ear congestion without other symptoms.  Hard to hear.  It is like water got into the ear after swimming.  Tried decongestant (Mucinex) and allergy medication (Allegra) and did not seem to help.
fatigue and rash on left upper back near top of shoulder.  Saw primary MD.  Booster vaccine given on 11/12/2021.  Continued rash and fatigue.   Saw Dermatologist   Dec 2021, treated rash w/ topical ointments.  Return visit in Jan 2022, biopsies / photos taken.   Diagnosis of dermatomyocytis.
I think the vaccine is safe. And I am totally fine. But I just want to add my response to the database to make it better for future reference. 1. I felt strong muscle pain at the injected arm around 12 hours later and woke by the pain multiple times. The next day (1/14/2021),  my left arm is still very painful if I lift it. This strong pain lasted a whole day (1/14/2021) and alleviated quite a lot since 1/15/2021. I'm likely to be one of the reported 90% with musle pain.  2. A mild headache similar to mild cold on the night after the injection. It dimishes next morning. This can be ignored.
This report describes synovitis in a female "minor" who received Lyme disease vaccine recombinant. This report was received as part of litigation proceedings and has not been verified by a physicians or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not provided. The vaccinee reportedly received LYMErix; the number of injections administered was not reported. In a statement of injuries, her attorney alleged that the vaccinee "has suffered from joint pain and swelling in her hips, ankles, and knees, and muscle pain in her calves and lower back. She has been diagnosed as having symmetrical chronic arthralgias, synovitis and a bilateral patellofemoral malaligment in both knees." Time to onset following immunization, treatment, and outcome of the alleged events were not reported.
receiving 3rd dose without being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (receiving 3rd dose without being immunocompromised) 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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced OFF LABEL USE (receiving 3rd dose without being immunocompromised). On 26-Aug-2021, OFF LABEL USE (receiving 3rd dose without being immunocompromised) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Within 45 mins of receiving dose #1 on 2/12/2021 I ended up getting the worst headache I've ever experienced in my life and within the follow 12hrs after the first dose I developed a low grade 100.7 fever and got hives all over my upper torso and neck. Within 12-18 hrs of receiving the 2nd dose on 3/12/2021 on 3/13/2021 I developed a 104.2 fever, hives from head to toe also my skin looked like a blotchy sun burn all over my body, I developed a severe migraine and I felt my tongue and throat starting to swell I'm a nurse and the city being shut down due to snow and ice and unable to seek emergency medical attention I immediately took 4 oral 25mg Benadryl tabs and gave myself 50mg IV Benadryl from  which stopped any further swelling of my tongue and throat but did nothing for the hives
3 days after the covid-19 vaccine, she had a seizure and was taken to the hospital. She was diagnosed with sepsis and died 02/22/2021.
consumer reports that pt devel a high fever of 102-103 & had a sz 1 wk following 3 immun of DT/HBOC/OPV;
Patient had echocardiogram performed 6 weeks prior to vaccination which was essentially normal. One week post-vaccination developed torrential mitral regurgitation due to posterior mitral valve leaflet restriction. Two-weeks post-vaccination, mitral regurgitation is now improving and leaflet no longer appears restricted.
Patient received the Moderna vaccine at 520pm. At 538pm she complained of throat closing. She felt like someone kept pushing her throat closed tighter and tighter. Pharmacist administered Epipen and patient was feeling better by 540pm.
Droopy smile, could not spit out of mouth, could not close right eye, pain in right eye, right ear, and behind right ear. Was dx'd with Bell's Palsy.
Administered 4th dose of Pfizer when patient was not immunocompromised per current guidelines, reported muscle pain that went away with Aleve
Headache, Myalgia, NauseaVomiting, chills Narrative: HA,chills, myalgia, nausea. Taking Motrin.
This spontaneous report was received from a medical assistant regarding unspecified patients. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX (lot # M015735, M049127, M015735 and N014366) (dose and route were not reported) for prophylaxis. The vaccine was exposed to a temperature of 6 Fahrenheit to 14 Fahrenheit for 15 minutes and 15 Fahrenheit to 46 Fahrenheit for 3 hours and 30 minutes. There were no previous temperature excursions. The call was because of a data logger. No adverse effects were reported. No additional information provided. No product quality complaint involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA008563: US-009507513-1708USA008564.
Patient did not receive the full dose; Leaked on Patient's Arm; Initial Report Received on 02-May-2023  A non-significant follow-up report received on 05-Jun-2023 that included the QA investigation results of the mixed product quality complaint: the investigation did not identify a potential lot-related issue, there was no trend.  No potential impact to the lot was identified.    the mixed product quality complaint: the investigation did not identify a potential lot-related issue,   there was no trend, this was the first AE associated with HEPLISAV-B lot 941588, no potential impact to   the lot was identified, no CAPA was recommended, and the case was closed on 30-Mar-2023.     A registered nurse reported that a 26-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization, which had a faulty needle connection and some of the HEPLISAV-B leaked on the patient's skin. The patient did not receive the full dose of HEPLISAV-B.  Medical history and concomitant medications at the time of vaccination were not reported. The patient had no allergies or previous reactions to other vaccines.  On 01-May-2023, the patient received the first dose of HEPLISAV-B vaccine (Lot # 941588; expiration date 31-Aug-2025, NDC # 43528-003-05; route of administration not reported) in the left deltoid by the reporting nurse. During the administration,  the needle connection was faulty, and some medication leaked on the patient's arm. The patient did not receive the full dose of HEPLISAV-B vaccine. This was the first dose of the two-dose series. No adverse reactions were reported by the patient.  No additional information was provided.  Company Comment:  The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
THE PATIENT HAD HOT FLASHES IMMEDIATELY AFTER THE IMMUNIZATION AND WENT INTO A ANXIETY ATTACK AFTER RECIEVING THE VACINE. SHE THOUGHT IT WAS ANAPHYLAXIS BECAUSE SHE IS ALLERGIC TO MANY THINGS, BUT IT WAS AN ANXIETY ATTACK. I GAVE HER WATER AND WE WORKED ON DEEP BREATHING EXERCISES. AFTER ABOUT AN HOUR SHE WAS COMPLETELY BACK TO HERSELF.
07/29/21 - About 15 minutes after the shot I felt woozy and started having hot flashes. After a few minutes it settled down. 7/30/21 - I woke up feeling just a little soreness where the shot was at and was relieved. No swelling or redness. Had lots of energy. After eating lunch, I suddenly felt tired and decided to lay down. By the time I did my hands turned cold. Within a few minutes I was freezing. My temp was 103.4 and I was shivering and shaking violently. Hardly able to even hold a bottle of water to my mouth. Took cool baths and Dayquil to bring my temp down.  Massive headache. Felt like I had COVID all over again. 7/31/21 - After a rough night I woke up feeling weak, shakey, headache, and got out-of-breath easily after just being up for a few minutes. Stayed in bed most of day and slept. 8/1/21 - Woke up feeling o.k. Throughout the morning I felt more energetic only to get tired around 2 p.m. and felt the need to take a nap again. No fever or anything; just tired. Slight headache. Arm suddenly swollen and feverish feeling. 08/01/01 - Woke up feeling ready to go for the day again only to realize once I got up I was weak, shakey, and breathless again after just a few minutes. Ok as long as I sit but broke out in a sweat if I did much. Got dizzy when tilting my head back to look up. Huge bruise on my arm at site.
Severe body aches and pain still continues after 7 days.; Sometimes it is difficult to walk due to the pain; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 23Feb2021 at 10:30 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), atorvastatin (MANUFACTURER UNKNOWN), acetylsalicylic acid (MANUFACTURER UNKNOWN) and Vit D3 (MANUFACTURER UNKNOWN); all taken for unknown indication from an unknown date and unknown if ongoing. The patient previously taken hydromorphone hydrochloride (DILAUDID), sulfamethoxazole/trimethoprim (BACTRIM), dextran sulfate (MANUFACTURER UNKNOWN) all on unknown date for unspecified indication and experienced drug allergy. On 26Feb2021 at 00:00, the patient experienced severe body aches & pains still continues after 7 days. Sometimes it was difficult to walk due to the pain. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe body aches & pains and difficult to walk due to the pain were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient came into the store on 10/7 with a large red spot where the injection had been given. Spot was dark red and had defined borders that did not look like a normal rash. Patient states that it is very itchy.
Initial information has been received from a physician and follow up information has been received from a registered nurse concerning a 15 year old female with no medical history, who on 14-APR-2009 was vaccinated with a first dose of GARDASIL (lot # 661846/1312X). There was no concomitant medication. The patient had blood work drawn a few minutes after receiving the vaccination. After the blood work was drawn. The patient fainted for approximately 15 seconds and may have had a minor seizure. The patient's eyes rolled to the back of her head and she became unresponsive for about 15 seconds. It was reported that her pupils were dilated and she was out for about 15 seconds. The patient regained consciousness and was given juice to drink. No medications or treatment were given to the patient. The patient stated that she did not have much to drink prior to the physician's visit. The patient was not hospitalized. The patient was observed for a little while and then was sent home with her mother. It was reported that the patient stayed home from school the next day and reported she was tired and had some muscle aches. On 15-APR-2009 the patient's mother was instructed to call the physician back if the patient continued with any problems. The physician advised the patient not to receive the remaining doses of GARDASIL. The patient did not receive any other vaccinations other than GARDASIL on 14-APR-2009. The patient had an appointment to see the physician on 07-MAY-2009. Upon internal review seizure was determined to be an other important medical event. Additional information has been requested.
tired feeling; 100 degree F temperature for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired feeling) and PYREXIA (100 degree F temperature for 24 hours) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 046A214 and 001A21A) for COVID-19 vaccination.     The patient did not have any allergies (medications, food and other products). The patient neither had COVID positive test nor had a diagnosis of COVID.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired feeling) and PYREXIA (100 degree F temperature for 24 hours). At the time of the report, FATIGUE (tired feeling) and PYREXIA (100 degree F temperature for 24 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100 degree Fahrenheit.         Concomitant medication of the patient was not reported.  The patient did not have any reactions after the first dose.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-544443 (Patient Link).   Reporter did not allow further contact
died; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's Comment: This case was reported by a patient's child via interactive digital media. The reporter stated that did not get shingles shot. The patient died after the shingles shot. Additional Supportive Information: The follow up would not possible as no contact details were available. The case had been linked to US2023AMR034316, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR034316:same reporter, other patient; Reported Cause(s) of Death: Unknown cause of death
Reddened injection site, swelling and pain, still visible as of 9/17/12.
Nodule under the skin at site of injection. Later turned into a large bruise (about the size of an orange) at the injection site.