chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On about 6/16/2021, when I got up at about 6:00 AM, I noticed that I felt a pressure and rapid fluttering in my chest. Ever since then, I have continued to feel the pressure and fluttering. It feels rather achy, sort of like I have a bruise in that area. The feeling is uncomfortable and causes me to toss and turn in bed and awaken early in the morning. I have also experienced extreme fatigue and sweating. My head seems to have also swollen, because caps now feel tighter and I sweat whenever I wear them. Caps are so uncomfortable now that I either have to loosen them or else take them off. I went to see my cardiologist, in July 2021. I told him about the chest pressure and fluttering, and he scheduled me to undergo a stress echocardiogram with treadmill in August 2021. I underwent the test, and Dr. said afterwards that he would have liked to see my heartrate achieved to a higher level on the treadmill. Dr. has scheduled me to undergo a carotid ultrasound on 9/30/2021
At 7:25P experienced sudden onset sore throat, chest tightness, hurt to breath, nasal congestion, "hurt all over"; bad headache, crusty-matted eyes that caused blurry vision. Redden eyes. Did not seek medical treatment or evaluation.
Information has been received from a registered nurse (RN) concerning a 6-month-old male who in August 2007, was vaccinated PO with a dose of Rotateq. The RN reported that in August 2007, the patient vomited after being vaccinated and the dose was re-administered. Unspecified medical attention was sought. No other adverse events were reported. At the time of this report, the outcome was unknown. Additional information has been requested.
Information has been received from a medical assistant concerning a 55 year old female with a history of chronic obstructive pulmonary disease and no known drug allergies who on 05-MAY-2009 was vaccinated intramuscularly in the right arm with her first 0.5 ml dose of PNEUMOVAX 23(lot# 66266/1435X). Concomitant therapy included Meclizine and PRINIVIL. On 06-MAY-2009 the patient developed a swollen, "tight feeling" and red right arm after administration of vaccine. At time of reporting the patient was not recovered. Follow up information was received from a medical assistant concerning the 55 year old female patient who was vaccinated intramuscularly in the right deltoid with the first dose of PNEUMOVAX 23 (lot# 662667/1435X) on 05-MAY-2009 (at 9:07 am). According to the patient, she developed swelling, warmth and erythema on 05-MAY-2009. The reporter considered the adverse experiences to be disabling. Additional information has been requested.
Patient was given Prevnar 20 into his left deltoid at an outside facility on 5/18/23 around 1500.  Several hours after administration, patient began noticing pain in his left shoulder. By 7 hours post administration, patient was experiencing severe pain in his left shoulder making left arm movement impossible. He presented to his primary care facility around 0900 on 5/19/23 complaining of ongoing severe left shoulder pain. The noted vaccine administration site was noted to mid upper third of patient's left deltoid with the puncture mark approx 1 cm inferior to his acromion. Patient with severe pain and guarding with palpation of his subacromiol-subdeltoid bursa and the inability to actively or passively move his left upper extremity due to the pain in his shoulder.
BLACK AND BLUE SIDE OF ARM - ICE AND TYLENOL FOR A FEW DAYS
The patient described having moderate muscle weakness shortly after injection.  This was mostly reported to occur in hi lower extremity.  He also described fatigue and left work early and he missed work the next day because of this also. His symptoms resoved fully as reported after just over 24 hours.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 82-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in April 2008 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated for Herpes Zoster resulting from his use of zoster vaccine live(ZOSTAVAX). At the time of the report, the outcome of Herpes Zoster was unknown. The reporter considered Herpes Zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
BLOTCHY RASH ON THE TRUNK (STOMACH TO CHEST); RASH ON UPPER INSIDE THIGHS (BOTH SIDE); RASH FROM ELBOW TO WRIST (BOTH SIDES); SHOULDER PAIN (DULL); This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced shoulder pain (dull). On 18-APR-2021, the subject experienced blotchy rash on the trunk (stomach to chest). On 18-APR-2021, the subject experienced rash on upper inside thighs (both side). On 18-APR-2021, the subject experienced rash from elbow to wrist (both sides). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shoulder pain (dull) on 12-APR-2021, and had not recovered from blotchy rash on the trunk (stomach to chest), rash from elbow to wrist (both sides), and rash on upper inside thighs (both side). This report was non-serious.
Constant pinching headache, ears clogged,  chills and sweats for two days. From waist down: leg weakness, nerve pain (like sciatica pain), diarrhea and couldn?t control pee twice on the night of the shot.  Took Tylenol pm to be able to deal with pain and sleep a bit  Feeling better today but leg pain is still strong
Shingles; Information was received from a lawyer regarding a case in litigation referring to a 66 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 05-OCT-2013, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(strength, route, dosage schedule, lot number and expiration date were not reported) for prophylaxis. As a result of receipt of zoster vaccine live(ZOSTAVAX), on 12-OCT-2013, patient was caused to suffer shingles, including any and all of its sequelae. As a result of receipt of zoster vaccine live(ZOSTAVAX), patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).  As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications.
Severe arm pain with cellulitis at site. Fever. All symptoms lasted 2 days.
On February 24, 2023, I came back to the boat and had a runny nose and was tired. I took a self-test, and it came back positive. I notified the Tour director and was put into quarantine. The next day a doctor came and gave me another antigen test and it was positive. I was put into quarantine in my room. I had a runny nose the next day, but it subsided after that. I was tired and slept a lot but that was it. After four or five days, I was back out again.
Rash on arms, chest and legs. Itches started Wednesday 12/15/04. Had flu shot 12/13/04. Had cardiac cath 12/9/04. No new meds except Benadryl since rash and itching developed. Doctor told him to take Benadryl and report incident to health department.
Patient discovered that she is pregnant approximately 4 days after the administration of Gardasil, Ttdap (Adacel), and Menactra.
Several hours after each vaccine administration, I had a slight break-out in hives. I took Benedryl per the recommendation of my doctor. After the first vaccine, I did not have subsequent hives. However, after the second vaccine, I had the initial minor break-out in hives the day of the vaccine and had the minor break out for a few days after.  After approx 4-5 days of getting the second vaccine, I had significant, daily breakouts in a rash as well as hives which continued on a daily basis thereafter spreading throughout different areas of my body.
Temperature alarm on the device shipped/ advised to not use the product; This case was reported by a pharmacist via other and described the occurrence of intercepted product storage error in a patient who received Flu Seasonal QIV (FluLaval Tetra) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra. On an unknown date, unknown after receiving FluLaval Tetra, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comment: The customer reported receiving 40 cartons of flu vaccines shipped directly from GlaxoSmithKline, which they immediately put in temperature tracked refrigerators after delivery. All tracking numbers delivered next day, with no delay.  They did not open the boxes or inspect the contents, including the temperature monitors, prior to storing.  The customer then reported several boxes with a tag alert alarm 2 upon being removed from the fridge and opened.  Total doses impacted was 8 cartons of 21 units (1680 doses).  The customer requested an exception to return these doses. The reporter reviewed the request and based on our current returns policy and exception processed, this did not qualify for an exception.  The shipping and handling guidelines posted on GlaxoSmithKline direct state that all cold chain containers must be opened immediately upon receipt and the temperature monitor reading verified.  There was no delay in refrigerating the product (confirmed by customer) and an alarm reading of 2 would only occur with delivery delays, or in the event the tag alert device was improperly handled i.e. put in a fridge.  Additionally, we ruled out a personal disaster claim because the vaccines were stored upon receipt. The exception to return the impacted vaccines was not approved. However, we did not advise the customer to use the product.  The customer cited a couple things that, caused them to store the vaccines without opening the boxes.  Namely, the quantity delivered (16,500 doses in 40 cartons) necessitated unpacking the shipping containers and storing the boxes efficiently.  They also mentioned that, the new shipping containers for flu vaccines; each container has 2 cartons and one temperature monitor so each carton would have to be opened. The customer did not handle the vaccines correctly by not inspecting each container.  The reporter could not confirm the stability of the vaccines upon receipt because the boxes were not opened. Additional Supportive Information: The customer did not handle the vaccines correctly by not inspecting each container, alert device was improperly handled and put in a fridge, which led to intercepted product storage error.
initial soreness in arm; Both knees were extremely achy for several weeks; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (initial soreness in arm) and ARTHRALGIA (Both knees were extremely achy for several weeks) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 40A21A. and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (initial soreness in arm) and ARTHRALGIA (Both knees were extremely achy for several weeks). At the time of the report, PAIN IN EXTREMITY (initial soreness in arm) and ARTHRALGIA (Both knees were extremely achy for several weeks) outcome was unknown. Not Provided          No concomitant medication was reported. No treatment information was provided.
3 in. diameter rash, perfectly round; This spontaneous case was reported by a consumer and describes the occurrence of RASH (3 in. diameter rash, perfectly round) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (3 in. diameter rash, perfectly round). At the time of the report, RASH (3 in. diameter rash, perfectly round) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information was provided.
Fatigue, headache & scratchy throat started on afternoon of 1/3/23. Extremely fatigued on 1/4/23, headache & chills. Slept 12 hours on 1/4/23. Woke up with congestion, headache, dry cough, sinus pressure fatigue on 1/5/23. Tested positive for Covid on 1/5/23. PCP prescribed Paxlovid. Headache & dry cough lasted a few days. Fatigue, stomach discomfort & diarrhea continue. Now on day 7.
This spontaneous report was received from a physician and a registered nurse referring to a 10 year old male patient. The patient's medical history included a non-accidental head trauma as baby. The patient's concurrent conditions included Attention-deficit/hyperactivity disorder (ADHD). The patient historical drugs included MMR. The patient never had chickenpox, herpes zoster or allergies. The patient's concomitant therapies included VYVANSE and INTUNIV. On 24-JAN-2008, the patient received a dose of injectable VARIVAX 0.5 mL, subcutaneously in his left thigh for prophylaxis (lot number reported as 1559U with expiration date on 27-SEP-2009) (strength and frequency were not reported) and sterile diluent (lot number reported as 1455U with expiration date in April 2010). On 24-JAN-2011, the patient received a dose of injectable PROQUAD 0.5 mL, subcutaneously in his left thigh for prophylaxis (lot number reported as 0649Z with expiration date on 29-OCT-2011) (strength and frequency were not reported) and sterile diluent (lot number reported as E009807 with expiration date in January 2012). No rash was detected at the site of vaccination injection following the vaccination. The reporter stated that, on 31-MAR-2017 (also reported as on 14-MAR-2017 by the register nurse), the patient visited the physician's office and shingles were detected on left side of the patient's back (also reported as "left side T2 posterior lateral" and "upper back"), next to his armpit level in a "4 by 4 cm" patch. Moreover, it was stated that, on an unspecified date, the patient was placed on acyclovir antiviral therapy 400mg/5cm (1 3/4 top, four times a day (qid) for 5 days) as treatment for the event. It was reported that the patient was afebrile and he did not have any other systemic symptoms. On 31-MAR-2017, a sample of a swab of an unroofed shingle vesicle was collected for further examination. On 03-APR-2017, the specimen arrived to the laboratory. It was reported that, on 04-APR-2017, the patient was "getting better" concerning the event of shingles. It was reported that, the specimen provided for polymerase chain reaction (PCR) analysis was an adequate specimen, no varicella zoster virus (VZV) deoxyribonucleic acid (DNA) was amplified but beta-globulin was amplified. On 12-APR-2017, the results were negative for VZV and did not detect the presence of varicella zoster virus. The relationship between the event of shingles and the therapy with VARIVAX and PROQUAD were not provided. Additional information is not expected as all correspondence was received.
Information has been received from a health professional concerning a 5-year-old white female who on 28-JAN-2003, at 3 years of age, was vaccinated with a dose of varicella virus vaccine live.  There was no concomitant therapy.  It was reported that on 07-JUL-2005, the patient developed chickenpox.  Medical attention was not sought and at the time of this report, the outcome was unknown.  Additional information has been requested.
Patient returned to clinic the day after having received his vaccine. He had redness and warmth to site as well as rash with itching to area of injection. Hive type rash around the injection site.
Around 9pm, I started getting the chills and some body aches. Body aches were worse in my hands, neck and lower back. By 10pm I felt extremely exhausted, continuing with body aches and chills. Around 12am I had a fever of 102.6 and extreme 10 out of 10 lower back pain. I have never felt more sick in my life. The back pain was so severe I thought I was having a kidney stone. I was ready to go to the hospital. The fever lasted until  about 4am when I took some ibuprofen. I felt tired and had mild body aches until 3pm the  following day.
Vaccine administered Nov 4, 2009-developed diarrhea on Mon Nov 9, 2009. Diarrhea lasted 7 days after which I developed severe joint pain and weakness. Still ongoing today 11-30-09.
administering only half the booster dose (0.25 ML) instead of 0.5 ml; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (administering only half the booster dose (0.25 ML) instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (administering only half the booster dose (0.25 ML) instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (administering only half the booster dose (0.25 ML) instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (administering only half the booster dose (0.25 ML) instead of 0.5 ml).    Concomitant medication was not reported. Treatment drug was not reported.
Three weeks after receiving second Moderna shot I developed extreme vertigo. I was doing my regular exercise routine during onset. Severity of vertigo made it difficult for me to stand up or walk. I went to the emergency department for medical evaluation.
there was an excursion where the temperature rise to 49.6f for 12 minutes and administered to patient post excursion with no reported adverse event; there was an excursion where the temperature rise to 49.6f for 12 minutes and administered to patient post excursion with no reported adverse event; Initial information received on 23-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient (26 cm and 7.75 kg) and there was an excursion for the vaccine IPV (VERO) [IPOL] and the temperature rise to 49.6f for 12 minutes and administered to patient post excursion with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   Concomitant medications included Hib Vaccine Conj (Tet Tox) (Acthib) and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Infanrix) both for Immunisation.  On 09-May-2023, the there was an excursion where the temperature of IPOL rise to 49.6 f for 12 minutes and administered to patient post excursion (product storage error) followed by the administration of suspect IPV (VERO) suspension for injection of dose 0.5 ml (lot: V1A022M, Expiry date: 17-Feb-2024) with unknown strength via intramuscular route in the left deltoid for prophylactic vaccination (Immunisation) with no reported adverse event (poor quality product administered) (latency: same day).  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  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 the guidelines. 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.
Information has been received from a pharmacist concerning a 62 year old female with no drug reactions/allergies who on 08-JUL-2010 was vaccinated with 0.65 ml ZOSTAVAX (Merck) (lot number, route and site not reported). On 09-JUL-2010 the patient developed "a couple of cold sores" under her nose after receiving a dose of ZOSTAVAX (Merck). The patient's "a couple of cold sores" persisted. There was no lab diagnostics studies performed. The patient called to the pharmacist to seek medical attention. Additional information has been requested.
Site: Pain at Injection Site-Severe, Systemic: Nausea-Mild, Additional Details: Patient claims injection was given at the wrong site and had severe pain at the time of injection with nausea and light headedeness. Pt awakened in the middle of the night to use the rest room and had the same sxs.  Patient called the pharmacy the next day and was advised to seek immediate medical attention. It is unkown if she consulted MD or went to the emergency room.