chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Began with what I thought was a UTI as I had cystitis type symptoms, then within 24 hrs, my fingers and toes started tingling and feeling of a weird sensation.  Soon thereafter, my muscles started to have shooting pains, and I had some tingling of my lips.  The muscle pains were so intense that I had to take several warm baths for palliative relief and pain killers to cope with the pain.  I missed work from Thursday thru Friday, and thought I had the weekend to get better.  Sunday night told me differently and I was able to see my Nurse Practitioner.  I was released to return to work on 11/8/2012.  I was till a bit weak, but began to gain strength and worked 2 days.  The following weekend was a 3 day weekend, which I took to rest my achy muscles.  Finally, on the 15th I felt like I was back to my old self.  I have a fever blister now, which I typically get at the end of an illness.
Shingrix late second doses; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix late second doses). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 09-AUG-2023 The physician assistant would like to know that if a patient received their first Shingrix vaccine and it had been years do they just get the second one or do they start over?   Also how much time is too long in between the two shots?     If they got shingles in between do they still finish the series? The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine on 3/29 leg pain 4/14 DVT seen on U/S 4/18
The only side effect I had from the vaccine was that I was tired the day after with a slightly sore arm. However, about a week before Christmas in December of 2021, I began experiencing mild intestinal issues like consistent diarrhea, gas and bloating that has not gone away.
This spontaneous report as received from a nurse practitioner refers to a 7 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 23-DEC-2014, the patient was vaccinated with the dose of LIQUID PEDVAX HIB lot # K008680 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). This is one of several reports from the same reporter. Additional information has been requested.
Initial reaction strong but normal.  Very sore arm, and fatigue.  One week after the vaccine though, my arm started hurting again at injection site, feels warm and itchy.  The ache though goes from top of shoulder all the way down arm and pain is significant.
A 70-year-old female reported that she inadvertently received a dose of Flumist (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) on 11-Oct-2003, and since then has had a "stuffy nose and a headache". Medical History: relevant medical history was not provided. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 11-Oct-2003. Dose regimen was 1 dose (intranasal). Concomitant therapy: Concomitant therapy included Evista (raloxifene hydrochloride). Event details: On 11-Oct-2003, subsequent to Flumist administration, she developed stuffy nose (nasal congestion) and headache (headache). As of 15-Oct-2003, the events had not resolved. No additional information was available at the time of this report.
Administered H1N1 vaccine to right deltoid- Patient immed started to turn red over entire body. Stated he felt his throat felt funny like it was closing- his eyes began to swell- immediately got MD for help AM + then got Benadryl BP 124/56 and he began to return to natural color- gave 25mg Benadryl and patient stated he felt better- waited 15min caller turned + BP 100/56 Pt left facility.
This spontaneous report as received from a registered nurse. The nurse stated doses of GARDASIL (doses unspecified in series, 0.5 ml, once, intramuscular) were administered between 24-JUL-2014 and 01-AUG-2014, doses were exposed to -1.5 C for 5 hours. No adverse effects reported. Nurse stated she had no patient specific information. This is one of several reports received from the same reporter. Additional information has been requested.
Atrial fibrillation 10.5 hours post vaccine. Propafenone administered orally. Afib dissipated 3 hours later
No other AE reported; temperature excursion involving GARDASIL 9,; This spontaneous report was received from a medical assistant and refers to a 12-year-old Hispanic male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 02-MAR-2021, the patient was vaccinated with improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot # T007035, expiration date 01-MAY-2022 (route of administration and anatomical location were not provided) for prophylaxis. The vaccine was administered by medical assistant. Administered dose of vaccine experienced the temperature excursion of 11 degrees Celsius for 10 hours on 16-FEB-2021. There was no previous temperature excursion. Digital data logger was involved. There was no adverse event reported. At the time of reporting, the patient had not experienced cellulitis, erythema or swelling at the site of the injection.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Medical Assistant; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA001526: US-009507513-2103USA001467: US-009507513-2103USA001532:
Upper arm to half way point to elbow very tender and 2x size. 2:00AM woke up with nausea, severe headache, unable to move from bed until 3:15AM-still trouble talking/swallowing and had tremor activity in all 4 extremities. 02/05/07-records received and reviewed for DOS 01/24/07-Dr. Lorenz HX of migraines in past has not been on any medication that treats migraines and Advil or Motrin is not helping them as well as they used to. Does not wake up with headaches. Does have photophobia with them, seem to be of tension headaches symptoms. No vomiting with them no neurological changes from them. She has had one that just seems to be king of lingering. She is on oral contraceptives for past 6 months and has not had any increase in migraines until now which is 6 months from the start of using the pill.  She received dose of Menactra and had difficulty swallowing for a little while. She had localized reaction on her arm but also had weakness and numbing type reaction in legs but did not progress into a true Guillain-Barre Syndrome.  Assessment: migraine headaches vs and or tension headaches. Reaction to Menactra.
Headache, low grade fever, rash hot to the touch at and near injection site, body aches
Late second dose of Twinrix/ first dose 11/23/2021 and the second dose 5 months later; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 42-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 23rd November 2020, batch number H4A37, expiry date 18th October 2021).   In April 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. In April 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. At the time of reporting, a month had approximately passed by since the 2nd dose. No further events were reported. The reporter consent to follow up.
Pain at injection site has been constant since injection received.  I have limited motion in my left arm. I notified my primary care physician on the Portal about two months after receiving the injection.  When I saw my physician for my annual check up on 01/22/2020, he told me the Pharmacist had hit a nerve when he gave me the shot. He told me the pain could last for a year.
within a couple of hours after being injected, I had a serious TRIGGER FINGER EVENT IN my let ring finger. I had to go to the office of my hand doctor and receive a cortisone injection in my hand,
patient developed a "tennis elbow" type pain in her left arm 1 day post vax - feels like rubberband around her elbow. Pain remains the same. Never had this problem in her left arm - a pulling sensation.
MMR vaccine 8/21/09. 9/7 - Developed aching and throbbing pain in left Tricept with escalating intensity. 9/15 - Presented for evaluation negative swelling, negative bruising, negative tender thighs.
Began spotting a week after receiving my Covid booster. My period was not due for another 2 weeks and is usually on a predictable schedule. Spotting lasted for 3 days.
In 2013, I underwent a successful heart ablation to treat atrial fibrillation and atrial flutter. On 12/26/2022, I checked my heartrate, which was at about 152 BPM, so my wife took me to the ER. I was admitted to the hospital, and I stayed overnight. I was taken off of hydrochlorothiazide, and my diltiazem dosage was increased. I was observed, and when I left the hospital, I still had atrial fibrillation and atrial flutter. I underwent a cardioversion on 1/18/2023. I underwent another heart ablation as an outpatient on 3/19/2023. After I was sent home, my heartrate dropped from 50 BPM to 36 BPM overnight, and I ended up going to another hospital on 3/20/2023. At the hospital, I was monitored overnight. On 3/21/2023, my doctor installed a pacemaker. On 3/22/2023, I was sent home. Since I got the pacemaker, things have been much better. I saw a NP on 5/4/2023. He indicated that I still had occasional atrial flutter and atrial fibrillation, but they are much more controlled now. He also said that it could take up to three months before they are resolved.
Stated since Xmas he has not feeling well after a family gathering. His wife in hospital for Covid-19 pneumonia. He reports for about 1 week, his SOB worsen, not eating well at all for the past 3 days. Which prompt him to visit the ED. Admitted to Hopital for Dehydration; Dyspnea; Pneumonia due to COVID-19 virus; COVID+ 1/10/21; still admitted
Initial report was received from a consumer, who was also the patient, on 10 July 2012. A 56-year-old female patient had received an intramuscular injection in the right deltoid of FLUZONE, sanofi pasteur Inc., lot number UH453AB on 26 or 27 December 2011. As soon as the patient received the vaccination, her right arm hurt. She experienced pain a few inches below the injection site and the pain has extended down to her hand. The right arm continued to be painful and she was unable to reach fully behind her back and could not reach back to "fasten bra". The patient had an x-ray done which was normal and had "nerve test done". The patient was diagnosed with tendonitis which then because arm was painful and wasn't being moved resulted in "frozen arm". The patient has had about 30 physical therapy sessions. The movement of the arm improved some but continues to have pain. The patient had no illness at the time of vaccination. Past medical history and concomitant medications were not reported. The patient's outcome was not recovered. Documents held by sender: None.
pt recvd vax & devel erythema multiforme & a measles-like rash; No further details were provided;
Pt recvd series of 3 Engerix-B vax deltoid; testing about 2 months p/3rd dose indicated titer was negative; 2 boosters given 1 mo apart.
NAUSEA AND VOMITING, PATIENT HAD SCIATICA ATTACK THE SAME DAY BUT SEEMS UNRELATED
Patient was exposed to a family member who was COVID-19 positive and tested positive on 7/16. Symptoms start on 7/16 with cough, fever, chills and SOB. Primary care doctor recommended he go to ED and receive casirivimab/imdevimab. Patient received the infusion on 7/21 morning. Then came back to the hospital in the evening due to worsening SOB and was admitted for hypoxia requiring oxygen.  Patient was started on remdesivir (7/22) and steroids and lovenox (7/21).  No longer febrile starting 7/23. Asymptomatic rash noted on patient's chest on 7/25 and no longer requiring oxygen.
Patient felt a lump on left arm after administration of vaccine, and evaluated 5/1/09. Returned 5/5/09 with redness/ warmth at injection site and complaints of headache, diarrhea, face flushing, exacerbated blood pressure. Pt started on Keflex 500mg 45x 1day x 10 days. )(184/100).
1 day after the second dose I experienced sever body ache. chills, cold sweat, fatigue, nausea, and fever. These symptoms were persistent through the majority of the day after my second dose. in the next 5-6 weeks, I experienced Nausea and shortness of breath every day.
5 pm  soreness increasing at injection site, bruise, very tender still 7pm aching,  fever. bad chills for appx 15 minutes, felt very ill. Fever was intermittent and mostly controlled by tylenol, mild chills, extreme fatigue, muscle and joint pain, and feeling overall very sick has lasted 24 hours
Given the bivlaent as 2nd dose of the primary series; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Given the bivlaent as 2nd dose of the primary series) 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 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Given the bivlaent as 2nd dose of the primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Given the bivlaent as 2nd dose of the primary series) 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 WRONG PRODUCT ADMINISTERED (Given the bivlaent as 2nd dose of the primary series).    Concomitant medication was not provided.  Pharmacist reported that inadvertently administered the bivalent dose to a patient who had one dose of the primary series.  Treatment information was not provided.
Vial initially stored on 31-JAN-2022 and then administered on 10-MAR-2022; The patient received dose after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 10-MAR-2022) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2022 at 8:41 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Mar-2022 at 8:41 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 10-MAR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 10-MAR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the vials were initially stored on 31-Jan-2022 and the thaw expiration date was 02-Mar-2022. It was also reported that the vial didn't undergo any temperature excursions.  The patient received their first booster dose.  No treatment information was provided.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 51-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 10 days after receiving SHINGRIX, the patient experienced shingles and drug dose administration interval too short. On an unknown date, the outcome of the shingles and drug dose administration interval too short were unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 6th July 2018, the patient received 1st dose of SHINGRIX. The patient received 2nd dose of SHINGRIX about 10 days before the 2 months mark, which led to shortening of vaccination schedule. The healthcare professional did not know the exact date of 2nd dose or lot number since this patient went to a different pharmacy. The patient broke out with shingles and the patient stated it was the worst case of shingles she has ever had. The healthcare professional had not seen this patient.
Information has been received from a nurse, for the Pregnancy Registry for Gardasil, concerning a 17 year old female with drug hypersensitivity and penicillin allergy and a history of asthma. on 26-APR-2007 the patient was vaccinated with Gardasil (Lot#655205/1426F). Concomitant therapy included ADVAIR and MENACTRA. On 01-MAY-2007 the patient's mother notified the office that her daughter tested positive to a home pregnancy test. It was reported that the patient sought unspecified medical attention. No further information is available at this time. Follow up information received from the pediatrician, indicated that the patient had a spontaneous abortion, on/or at less than 20 weeks of gestation (date not specified). The outcome of spontaneous abortion was not specified. No further details were provided. Upon internal review, spontaneous abortion was considered to be serious as an other important medical event. Additional information is not expected.
headaches; This is a spontaneous report received from a non-contactable reporter.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
DIVERTICULITIS; ULCER; LOST APPETITE; FELT BAD; LOST WEIGHT; BODY  NUMBNESS; BODY WEAKNESS/NO ENERGY; TERRIBLE FATIGUE; This spontaneous report received from a patient concerned an 80 year old female. The patient's weight was 100 pounds, and height was 60 inches. The patient's past medical history included: gastric bypass(has been on vitamins for it unspecified) could not raise arm in 1960 after giving birth was unable raise her arm until a doctor suggested vitamins and patient felt better within 2 weeks, and concurrent conditions included: non-smoker, non-alcoholic, tree allergy, atrial fibrillation, asthma, thyroid deficiency(on thyroid medications), cholesterol issue, and patient had one arm only, lost one arm due to bone cancer. Patient experienced sensitivity to oven cleaner,(which had difficulty breathing and ended up in the hospital and her asthma symptoms started from that point). Patient had no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 18-SEP-2021) dose was not reported,1 in total, administered on 01-APR-2021 for prophylactic vaccination on right arm. Concomitant medications included metoprolol and rivaroxaban for atrial fibrillation. On 22-APR-2021, 3 weeks after receiving the vaccine, the patient felt bad with no energy, terrible fatigue and body weakness and numbness and patient also lost appetite, lost weight and contacted doctor because patient thought that was cancer. Patient primary care physician did blood work and checked everything and it were okay. Primary care physician sent patient for colonoscopy in which it was detected patient had diverticulitis and ulcer that physician addressed. The patient indicated that patient was feeling better(at least 50% better).  Laboratory data included: Weight (NR: not provided) decreased, Blood work (NR: not provided) was okay, and Colonoscopy (NR: not provided) diverticulitis and ulcer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost appetite, and lost weight, and was recovering from felt bad, terrible fatigue, body weakness/no energy, diverticulitis, ulcer, and body numbness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211045982-Covid-19 vaccine ad26.cov2.s-Diverticulitis. This event(s) is considered unassessable. The event(s) 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(s).
10 mins after injection, patient reported her tongue felt "rough and swollen". Reports being able to "taste vaccine". BP 189/110. 25mg benadryl given PO and patient given snack. Approximately 30 mins after injection, patient reports her tongue and lips were swelling. BP 170/128. Epi-pen administered, EMS called and patient transported to hospital at 12:45pm.