chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received on 05 January 2012 from another manufacturer, report number WAES 1112USA01054. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: Information has been received from a registered nurse concerning a 9 year old patient who on 25-JUN-2002 was vaccinated with a dose of VARIVAX (Merck) (Route, dose and lot number not reported). On 24-MAR-2010 the patient experienced rash. The patient was seen by pediatrician to seek medical attention. On 01-APR-2010 the patient experienced meningioencephalitis and was hospitalized and diagnosed. On 10-SEP-2010 the patient was diagnosed with shingles. At the time of the report, the patient was still recovering. This is one of several reports received from the same source. Follow up information has been received from a healthcare professional concerning the 9 year old female student with milk intolerance who on 25-JUN-2002 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot#: 640556/0258M) in the left thigh. Secondary suspect therapy included the first dose of MMR II (lot#: 641722/0127M, HSA) and the fourth dose of TRIHIBIT on 25-JUN-2002. On 01-APR-2010 the patient experienced zoster with secondary meningioencephalitis and was hospitalized for eight days. Subsequently, the patient recovered from zoster and secondary meningioencephalitis. There was unspecified lab performed at other institution. The adverse events of zoster and secondary meningioencephalitis were considered to be immediately life-threatening and disability by the reporter. A lot check had been initiated. Additional information is not expected." No further information was available at the time of the report. A revised version was created on 16 January 2012 due to a discrepancy in the case receipt date that was noted upon internal quality review of the initial version. Specifically, the Date Received By Mfr (Field 25 of the VAERS report) was entered as 06 Jan 2012 while the date of initial receipt by the Company was entered as 05 Jan 2012 in the Description of Adverse Event (Field 07 of the VAERS report). The correct case receipt date is 05 Jan 2012. However, the date cannot be amended in Field 07 of the VAERS report because of technical constraints (a new version can not have an earlier date than any prior version). Documents held by sender: none.
My father got his first Moderna shot from a pharmacy and had an injection site reaction to left arm started itching and then bumps appeared and then stopped.  Went back for second shot and same thing occurred and resolved. Then went to go get the booster made the two RN's aware had injection site reaction with itching and bumps both times. Was advised that it was okay to continue with his booster.  Was given his booster at hospital on 12/9/2021 and had the same itching and bumpy reaction. But now ever since then he has had issue with systemic spontaneous really bad itching and bumps
Pain from injection site to elbow - hot red blotches - one blotch is size 2"x4" - several other - pain inside of arm - could not sleep after several days due to pain. Called nurse for advice.
DEATH; ADVERSE REACTION TO THE JANSSEN AND JANSSEN VACCINE; OFF LABEL USE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a consumer via social media concerned a 4 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was reported that the patient was 4 year old (child), it was not a approved age to receive vaccine (coded as product administered to patient of inappropriate age and off label use). On an unspecified date, the patient experienced an adverse reaction to the JANSSEN AND JANSSEN vaccine. On 23-DEC-2021, the patient died from an unknown cause of death. It was unspecified if an autopsy was performed. Reporter also stated that ''My friend's neighbor's 4 year old cousin just passed away after an adverse reaction to the J&J vaccine. Absolutely devastated for them. Please pray for their family.''. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 23-DEC-2021, and the outcome of adverse reaction to the JANSSEN AND JANSSEN vaccine, off label use and product administered to patient of inappropriate age was not reported. This report was serious (Death). This report was associated with product quality complaint: 90000208442.; Sender's Comments: V0:20211252331-COVID-19 VACCINE AD26.COV2.S- Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
FELT NEEDLE GO IN; INSOMNIA DUE TO PAIN; SORENESS IN RIGHT ARM; FELT FEVERISH; MUSCLE ACHES; FATIGUE, TIREDNESS; SLEEPINESS; PAIN IN WRIST AND LOWER BACK; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included: surgery and pains especially in his wrist and lower back. The patient was previously treated with covid-19 vaccine ad26. cov2.s (Dose Number in Series: 1) for prophylactic vaccination in MAR-2021 and had no adverse event.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: UNKNOWN) dose was not reported, (Dose Number in Series: 2), 1 total administered on 28-OCT-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 28-OCT-2021, 3 to 4 hours after getting the vaccine (booster dose), the patient experienced fatigue, tiredness, sleepiness, and muscle aches and pains especially in his wrist and lower back which he had problems with before the booster but that the pain was slowly getting better due to his use of medical marijuana for the pain. On an unspecified date, the patient experienced felt needle go in, insomnia due to pain, soreness in right arm, and felt feverish. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97.3 F.  Treatment medications (dates unspecified) included: oxycodone, and cannabis sativa. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for events was recovering. However, it was also reported, patient was feeling better and that the symptoms were recovering. Tiredness, sleepiness, fatigue were better, wrist and back pain were a lot better and no longer feels feverish. The patient recovered from pain in wrist and lower back, and felt feverish, and was recovering from soreness in right arm, sleepiness, fatigue, tiredness, muscle aches, felt needle go in, and insomnia due to pain. This report was non-serious.
Left arm got sore night of injection, by next morning 10/31/02, had throbbing pain up into neck, took Tylenol for 4 hours and took Benadryl 10/31/02. Arm remains sore 11/01/02 but pain in neck gone.
10 minutes after vaccine lips swelled, itching tongue after 45 minutes. Monitored for 1 hour at hospital then for another 2 hours at home. No medicine was given, but was offered. I have history of anaphylaxis and said I wanted to wait and see if it would resolve without medicine or at least not get worse. So far still I worse, if it would have gotten worse it would have happened already.
Temp 104, day 11-day 12. Rash day 14. Swelled lymph nodes (groin) day 13. Visited local ER-treatment only for symptoms.
Pt exp t101, SOB, occasional stabbing feeling in chest day p/vax; also exp soreness of the arm & a feeling of hands wanting to draw closed; 2 days later arm red, swollen, warm, & painful; Seen in ER dx cellulitis due to strep infect;
Redness; No appetite/lack of appetite leading them; Rash on the stomach; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), ERYTHEMA (Redness), DECREASED APPETITE (No appetite/lack of appetite leading them) and RASH (Rash on the stomach) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C2IA) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Cancer. Concomitant products included VERAPAMIL HYDROCHLORIDE (VERPAMIL), METFORMIN, VITAMIN D NOS, LETROZOLE and SPIRONOLACTONE for an unknown indication.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), DECREASED APPETITE (No appetite/lack of appetite leading them) and RASH (Rash on the stomach). On 12-May-2021, the patient experienced ERYTHEMA (Redness). On 12-May-2021, RASH (Rash on the stomach) had resolved. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and DECREASED APPETITE (No appetite/lack of appetite leading them) outcome was unknown and ERYTHEMA (Redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow-up included a TCR with no new significant information
Initial unsolicited report received from a consumer on 19-AUG-2016. This case involves a 27-year-old female patient who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B INTRADERMAL ADULT SUBVIRION VACCINE (FLUZONE TIV) (batch number, expiry date, dose, site of administration were not reported), intramuscularly on 14-Oct-2013. Patient's Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as mast cell disease. Patient's concomitant medications were not reported. On 14-Oct-2013, 12 hours following the vaccination, the patient had a temperature of 101.8 degree F, vomiting and diarrhea. It was reported that the patient required ER visit. Lab data was reported as none and corrective treatment were not reported. On an unspecified date, the patient recovered from the event. List of documents held by sender: none.
Mother reports student on Sunday morning started to cough and have shortness of breath. Took her to the ER - they gave her treatments, sent home to use nebulizer inhaler. Student  has no history of asthma.
Sleeplessness; Listless; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL4249) via an unspecified route of administration in the right arm on 01Feb2021 at 08:30 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received medications within two weeks of vaccination. On 04Feb2021 at 14:15, the patient experienced sleeplessness and listless. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. On an unknown date, the patient underwent nasal swab and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event sleeplessness and listless was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Stomach pain; Numbness in toes and legs, feet and hands are numb; This case was reported by a consumer via interactive digital media and described the occurrence of stomach pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced stomach pain and numbness of extremities. On an unknown date, the outcome of the stomach pain and numbness of extremities were unknown.   It was unknown if the reporter considered the stomach pain and numbness of extremities to be related to Shingrix.     Additional Information: GSK Receipt Date: 6-May-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingrix vaccine and experienced stomach pain and numbness in toes, legs, feet and hands. Additional supportive information: The follow-up would not possible, as no contact details were available.
Patient received under diluted dose of covid 5-11 vaccine. Complaints of nausea and vomiting  7 days after vaccine administration.  Zofran prescribed for patient.
Herpes Zoster, Ophthalmicus/herpes zoster with ocular movement; Zoster-related injuries; Herpes Zoster, Ophthalmicus/herpes zoster with ocular movement; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, historical conditions and concomitant therapies were not reported. On or about 04-NOV-2011, the 77-years-old patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions by a pharmacist in a pharmacy. Subsequently, the patient  was treated by healthcare providers, including but not limited to a physician for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: Herpes Zoster, Ophthalmicus/herpes zoster with ocular movement, and other Zoster-related injuries. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).     Upon internal review, the event of ophthalmic herpes zoster was considered to be medically significant.
This spontaneous report has been received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. It was reported by the pharmacist that on 28-FEB-2017-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route of administration, and frequency were not reported), for prophylaxis. A digital data logger was used.  No adverse effects were reported. This is one of multiple reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014153: 706USA001720: Original Case : 1706USA001714 US-009507513-1706USA001714: Original Case : 1706USA001714 US-009507513-1706USA001722: Original Case : 1706USA001714 US-009507513-1706USA001723: Original Case : 1706USA001714 US-009507513-1706USA001719: Original Case : 1706USA001714 US-009507513-1706USA001724: Original Case : 1706USA001714 US-009507513-1706USA001725: Original Case : 1706USA001714 US-009507513-1706USA001726: Original Case : 1706USA001714 US-009507513-1706USA001727: Original Case : 1706USA001714 US-009507513-1706USA001728: Original Case : 1706USA001714 US-009507513-1706USA001729: Original Case : 1706USA001714.
Mother states child immediately began to feel groggy, nauseated, and vomited after shots, Mother states child felt feverish (not documented with thermometer) no appetite and cranky since receiving the immunizations. Mother did not take child for f/u at MD.
pt recvd vax & was later adm to hosp w/GBS which may be R/T flu virus; pt was on ventilator & has recvd a series of treatments w/plasmaphoresis
I woke up the morning afer the shot and when I tried to stand my legs felt like I had concrete boots on.   I could hardly lift my feet. I also had shortness of breath, and general body fatigue.  Proceeded to check with coworkers about any side-effects they may have had. I thought maybe I was being too sensitive.  The symptoms continued and worsened. I had a job where I had to walk and pickup trash, climb hills, etc. I was so fatigued that I could only walk for 15 min before resting.  Began using my PTO for full days not working. I just lay in bed or sit and read all day. The days I worked were horrible. I stopped climbing hill and made excuses to my bosses.  I got Albuterol inhalers from my doctor and used therm to catch my breath often. By the time came for my booster, my condition scared me away from another dose. Within 2 months I had used up all my vacation days. When I requested a refill of the inhaler, my doctor wanted to see me.  I explained the problem in an email, which I still have somewhere (it's 2 pages) He wanted me to come in and when I did he told me to go to a different clinic for some tests.  I went where I believed he told me to go, but the receptionist didn't know anything about me.  I had to get to work so I called Dr on the way in and he said I had the wrong place.  That day at work I asked a supervisor for "less strenuous work" and was told that my job was what it was.   Since I was all out of PTO allI could do was leave. That was my last day at work.  The symptoms really haven'tlet up much in the past year.  Afetr losing my job ("quitting" they called it) I spent all my savings to supplement on my pension. My last month in my apartment was Jan2022. I now live in my car, because I can still afford food and bus fare.  I lost my wallet 4 days ago on the bus, so I don't have my vaccine card. The dates were on it so I may be off without evidence.
Sore throat; Cough; Feel exhausted; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sore throat in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced sore throat (Verbatim: Sore throat), cough (Verbatim: Cough) and exhaustion (Verbatim: Feel exhausted). The outcome of the sore throat, cough and exhaustion were not reported.   It was unknown if the reporter considered the sore throat, cough and exhaustion to be related to Arexvy.   It was unknown if the company considered the sore throat, cough and exhaustion to be related to Arexvy.   Additional Information: GSK Receipt Date: 27-OCT-2023 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The follow up would not possible as no contact details were available.
1-ER visit #1 -ITP - large bruises, purpura - blood filled blisters in mouth - absolutely zero platelets upon entering ER -   2-admitted to hospital for several days - given IGG and oral steroids - released from hospital  3-ER visit #2- back to ER day after discharged with severe headache to make sure no brain bleed - discharged after no signs of bleeding on CAT scan  4-ER visit #3 - back to ER - headache hadn't subsided next day - Doctor wanted an MRI to make sure no brain bleed - found none - discharged.
Severe headaches and pain, right foehead, right side of head and neck and right side back of neck.  Skin in hair on right side hurts to touch.
ITCHING; REDNESS OF SCRATCHES; WELT ON ARM; SWELLING; This spontaneous report received from a patient concerned a 71 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced itching. On APR-2021, the subject experienced redness of scratches. On APR-2021, the subject experienced welt on arm. On APR-2021, the subject experienced swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching, redness of scratches, and welt on arm, and the outcome of swelling was not reported. This report was non-serious.
Died 7 days after receiving 2nd dose of Moderna vaccine. Had underlying hx Lung CA w/mets.
chills; joint soreness; tiredness; This case was reported by a consumer via call center representative and described the occurrence of chills in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 24th August 2020 08:00, the patient received the 2nd dose of Shingrix. On 24th August 2020, less than a day after receiving Shingrix, the patient experienced chills, soreness of joint and tiredness. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the chills, soreness of joint and tiredness were recovering/resolving.   The reporter considered the chills, soreness of joint and tiredness to be related to Shingrix.  Additional details were reported as follows: The patient received his 2nd dose of Shingrix at 8 AM on 24th August 2020 in left deltoid. On same night, he developed chills, joint soreness and tiredness. On morning of 25th august 2020, he felt same so he took Tylenol. He was feeling better at time of reporting. The reporter consented to follow up.
severe headache and fatigue low grade fever ranging from 100.1 to 100.9 took tylenol for fever and headache
Tired feeling; Joint pain; Vomiting; Shaky feeling; Migraine; Stiff neck; Slight headache; This is a spontaneous report received from a contactable healthcare professional, the patient. A 42-year-old non pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the left arm on 17Mar2021 at 14:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines, hypothyroidism, tension headache (on 16Mar2021) and allergic to mold. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included SYNTHROID, ZYRTEC and MIDNITES, all for an unspecified indication, initiated on unknown date. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 24Feb2021 at 14:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient previously took aspirin and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021, immediately after the vaccination, the patient experienced a bit of a stiff neck and still had a slight headache. Over the course of about 5 hours at 19:00, the headache turned into a migraine with splitting head pain, shaky feeling and vomiting. The patient was self-treated with two TYLENOL rapid release, but only managed to throw them back up. She went to sleep and by about midnight she was feeling mostly better, with only a slight headache and tired feeling lingering. She felt fatigued and had some minor joint pain at the time of the report. The clinical outcome of the events stiff neck, migraine, vomiting and shaky feelings were recovering; tired and headache was not recovered and the outcome of joint pain was unknown.  No follow-up attempts are needed. No further information is expected.