chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received first dose more than a year and a half ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose more than a year and a half ago in a different state).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-AUG-2022 Reporter's comment: The vaccine lot number and expiration date were unknown. Exact administration date of first dose was unknown. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Moderna vaccine was administered outside of facility- reported by patient ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------- J96.00 ACUTE RESPIRATORY FAILURE 12/9/2022 PNEUMONIA R09.02 HYPOXIA 12/9/2022 PNEUMONIA
On May 24, 2021, I woke up and within a few minutes experience 3 syncope episodes. Went to the ED and spent the night in the hospital in observation. All tests normal. Explanation was I was likely fighting a virus that dropped my BP. Don't know if it was Covid or vaccine-related or if it was my vaccine was working but it was an unexpected adverse event. No history of syncope or any underlying conditions or co-morbidities.
altering mid brain stroke; This case was reported by a consumer via interactive digital media and described the occurrence of stroke in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, 24 hrs after receiving Meningococcal B vaccine, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke was unknown.   It was unknown if the reporter considered the stroke to be related to Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. The patient was experienced about her life altering mid brain stroke 24 hours after receiving this vaccine.
I developed shingles. Left leg and left glut. Still dealing with lingering itch and pain. Blisters are gone now. Treated with anti viral and pain medication
urinary tract infection; A spontaneous report was received from a consumer concerning a 86-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced urinary tract infection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, prior to the onset of the events the patient received the second of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced urinary tract infection.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of urinary tract infection was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Extreme swelling, redness, and itching at place vaccine was injected one week after  vaccine
left arm/hand went numb, wrist pain, injection spot was hard, insomnia with fast heart rate, wakening with jolts from my heart and blood pressure spikes. Second Moderna vaccine given 5/12/21 039B21A.  on 5/22 vision changes, vertigo, headaches, loss of bladder control, could not have bowel movements, internal tremors, pelvic pain, memory loss, word loss, speech problems, sever fatigue, leg and arm weakness, adrenalin rushes and extreme sensations of "over sensitivity through out entire body. 2 days of not being able to swallow solid food. Lost 14 lbs in 3 weeks. The feeling the my body was being attacked from within. Clenching feeling from back of head down my neck to my chest. flushing and sweating. lower back pain.
Pt statEs hE developed a headache, chEst pAIN, chills + pAIN @ immunization sitE. 2 days latER hE statEs hE had pain + burning with uRination X 1. 1200 - chEst pAIN, headache. 1800 - pAIN + swElling @ injEction sitE + developed chills. Chills off + on x 2 days Chest pAIN off + on x 1 day pAIN + SWElling to (R) dEltoid (inj. sitE) - 8 days Headache x 4 days. Pt did not REport to mEdical at time of incidEnt. Seen by PA on 1/8/20
Rash to left arm (vaccine site, red, raised, patchy, very itchy).
Mother notice redness & swelling on 3/30/11 on right arm. Patient is getting treated with antibiotic KEFLEX for cellulitis.
SIGNIFICANT LEAKAGE FROM THE INJECTION SITE OCCURRED. PHARMACIST IN BEST JUDGEMENT REPEATED DOSE ON OPPOSSITE ARM.
No adverse events that I am aware of.  Pt was informed after receiving high dose that pt should have received regular dose and the potential of increased local reactions.  Pt had stated understanding.
Numbness in right hand and lower right leg Sores in mouth requiring treatment Nausea and chills for 3 weeks
She broke out in hives for 3 days following the vaccination. It was DTap but I am unsure of whether is was DAPTACEL or INFANRIX.
Three days after vaccine, Inflammation of joints, lymph nodes, muscles, sinuses, sweats, fever.  A month plus in duration.  Treatment was medrol dose pak and singular, and allegra.
pt recv vax 26AUG96 & that evening devel induration on upper arm from shoulder to elbow;
Symptoms: Ringing in rt ear; hearing loss rt ear; dizziness/Nausea  Treatment: Prednisone, Meclizine
Client arrives to observation tent. Stated she was feeling dizzy and nautious. Client decied to lay her self to the ground. Client declines any injury. RN and Ems assess client. VS 98%02 123/85 BP 89HR.  Client ststes she has a history of type 1 diabeted and cilliac disease. Also states she has a hx of passing out when recieving vaccine/shots. Client has a continious blood sugar monitor. Blood glucose reads as 141.
Bowel incontinence; Colopathy; This spontaneous case was reported by a consumer and describes the occurrence of ANAL INCONTINENCE (Bowel incontinence) and GASTROINTESTINAL DISORDER (Colopathy) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. On an unknown date, the patient experienced ANAL INCONTINENCE (Bowel incontinence) and GASTROINTESTINAL DISORDER (Colopathy). At the time of the report, ANAL INCONTINENCE (Bowel incontinence) had not resolved and GASTROINTESTINAL DISORDER (Colopathy) had resolved.            No concomitant medications were reported.   On unknown dates, the patient experienced had episodes of felt like hard to control bowel movements and covid vaccine caused colon to felt worsened. On an unknown date, covid vaccine caused colon to felt worsened resolved.   It was unknown if patient was enrolled in a COVID-19 vaccine trial.   No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Changes in menstrual bleeding including bleeding excessive amounts of fleshy tissue type blood for a couple months following the vaccine. This has never occurred before.
Slight headache and vertigo when getting up after sleeping. Able to walk but have to be careful. Lasts for 15-20 minutes unless I drink coffee -- then it goes away after about 5-10 minutes, with headache last to go. With vertigo: Blood pressure normal. Heart rate normal. Blood O2 normal. Temperature normal. Had a constant three day case of vertigo back in 2003 after flu-like illness. This is much less severe, but now on 11th day.
SWEATING; SORE THROAT; LIGHTHEADED; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 43 year old of unspecified sex. 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, treatment medications included: ibuprofen. On 10-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced fever. On 14-APR-2021, the subject experienced sweating. On 14-APR-2021, the subject experienced sore throat. On 14-APR-2021, the subject experienced lightheaded. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 14-APR-2021, was recovering from headache, and chills, and had not recovered from sweating, sore throat, and lightheaded. This report was non-serious.
Information has been received from a licensed practical nurse concerning a 22 year old female patient with no medical history who on 06-JUN-2007, was vaccinated IM with a first 0.5ml dose of GARDASIL (Lot# 657622/0388U). Concomitant therapy included penicillin (unspecified). On that same day, the patient developed itch from head to toe, swelling of her hands and feet and quarter sized welts all over body. The patient was seen in the emergency room for evaluation. On 15-AUG-2007, the patient was vaccinated IM with a second 0.5ml dose of GARDASIL (Lot# 658488/0930U). On that same day, the patient developed the itch all over her body, but did not experience any of the other previous reactions. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Patient presented today for mRNA vaccine following previous Janssen dose in March 2021.  Her specialist recommended she complete mRNA series.  Vaccine administered, patient felt flush and stated she felt she was developing hives from her neck down.  She was brought back to exam room.  Vital signs obtained, stable.  No difficulty breathing or shortness of breath.  No swelling of face, neck, throat.  Alert and oriented x3.  Spoke in full sentences.  History of chronic urticaria, takes benadryl when needed.  Benadryl offered, patient said she could wait and take at home.  Discussed Pfizer dose #2 would still be recommended to complete the series.  Patient left the clinic feeling better, continued with flushed skin around neck area, mostly anterior neck.  No appreciated hives.
Loss of hearing in left ear- nerve damage* Fever, muscle aches, joint aches, fatigue, headache
Chest Pain for ensuing 3 days after I received the vaccine.  It felt like my chest was getting squeezed all day.
itching in various places / occurs all over / legs, midriff, scalp, face, feet, etc. / aren't any bite marks or bumps / not / continuously, but pretty frequently; high fever; was under the weather; little bit of weakness; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number KB97C, expiry date 13th November 2022) for prophylaxis.   On 16th July 2021, the patient received the 1st dose of Shingrix. On 17th July 2021, 1 days after receiving Shingrix, the patient experienced fever, feeling unwell and weakness. On an unknown date, the patient experienced pruritus. On 19th July 2021, the outcome of the feeling unwell and weakness were recovered/resolved. On an unknown date, the outcome of the fever and pruritus were unknown.   It was unknown if the reporter considered the fever, feeling unwell, weakness and pruritus to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. A health care provider (Immunizations director) reported that, the patient experienced high fever and was under the weather for about 2 days with a  little bit of weakness and itching. Since the patient got the shot, had been itching in various places to the point that and wonders if she had bugs in her clothes or bed (which the patient thought she did not since her husband had not been itching). The itching occured all over, sometimes patient´s legs, midriff, scalp, face, feet, etc.  There were not any bite marks or bumps in the skin where the itching occurs. The patient reported not itching continuously, but pretty frequently. The reporter consented to follow up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  An 80-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing), notes: Prediabetes; "Gout" (unspecified if ongoing); "hypercholesteremia" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: tested positive again 7 days after completion of Paxlovid. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. Other medication in 2 weeks was reported as yes. No Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug infective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Smothering; Blood pressure was so low/read 80/50 mmHg; Clammy; Sweaty; Nauseous; Vomited; A spontaneous report was received from a consumer who was a 70-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  nauseous, vomited, smothering (suffocation feeling), clammy (cold sweat), sweaty (hyperhidrosis), and blood pressure was so low at 80/50 mmHg (hypotension)  The patient's medical history, as provided by the reporter, included that she was a "heart patient."   The patient was "on a lot of regular medications" but did not have a list of them available.  On 23 Jan 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly on her left deltoid for prophylaxis of COVID-19 infection.  On approximately 27 Jan 2021 (reported as 4-5 days post vaccination) she was nauseous, vomited one time, was smothering, clammy and sweaty, and her blood pressure was so low, it read 80/50 mmHg.  She "thought it was a heart attack."  On an unspecified date, the patient was kept overnight for a heart stress test and x-ray (results not provided).  No treatment was given for the events.   Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of events of nauseous, smothering, clammy, sweaty, and blood pressure was so low (80/50 mmHg) were unknown at the time of this report.  The event of vomited was considered resolved on approximately 27 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded. Further information has been requested.
Information has been received from a physician concerning a 34 year old healthy male with no food or medication allergies and was negative by history for chickenpox, with a confirmed negative IgG titer (previously reported as a history of previous varicella as a child) who is the father of a 15 month old female who was vaccinated on 11Mar04 with a 0.5ml dose of varicella virus vaccine live (lot 647521/1108N). There was no recent exposure to chickenpox or shingles. There was no concomitant medication. On 01Apr04, he presented with over 100 lesions but only mild symptoms. As of 15Apr04, the pt had over 500 lesions described as diffuse on the face, trunk, arms and legs but was still with mild varicella symptoms. Other systemic symptoms included fatigue (also described as malaise), fever and a mild increase in ALT. A DFA of the lesion was positive for VZV. On 13Apr04, the PCR analysis revealed the vesicle specimen contained wild type varicella zoster virus. It was noted that the pt had other labs drawn that were pending. It was also noted that the pt was being treated with acyclovir. Subsequently, the pt recovered. The reporter also mentioned that the daughter of the pt who was vaccinated with varicella virus vaccine live developed a low grade fever and 10 lesions on her trunk (WAES0405USA00164). Additional information has been requested.
Two weeks after vaccine I started having heart palpitations and getting light headed.  Went to the doctor and they said I had a Urinary Tract Infection which I haven't had in over 40 years.  I went on antibiotics and the symptoms went away while on the antibiotics as soon as I was done the symptoms came back.  It has been 5 months and I still am not feeling like I did.
By the night of receiving the vaccine, my armpit lymph node got very large and swollen. It was sore and the size of a baseball. It kept growing for the next 3 days. The pain radiated from my breast to my shoulder joints. My armpit node is going down but now I have one on my collar bone that has appeared. It has been 5 days. The collar bone bulge is not as big as the one under my armpit. It hurt to move my arms, wear a bra, put my arms down. After a few days of taking Motrin and it not helping, I called the advice nurse and they suggested icing it. They told me to check for any streaking due to infection. The lump was only red. My armpit node has gone down since but now the one on my collar bone seems to have gotten larger. I was also very exhausted while the armpit lump was present.
A report was received on 28 February 2002 concerning an 81-year old male patient who was hospitalized for COPD exacerbation on the same day he received Fluvirin vaccine, on 04 November 1998.  The causality was stated to be possibly related. No further information was provided.
This case was reported by a pharmacist via out of hour services and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On 6th August 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 30 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that a patient received the SHINGRIX vaccine and she had an outbreak of shingles a month after the first dose.
Kinrix unintended extra dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number D947X, expiry date 25-JAN-2025) for prophylaxis.   Previously administered products included Kinrix (1st dose received on an unknown date in 9-AUG-2022).   On 28-JUN-2023, the patient received the 2nd dose of Kinrix. On 28-JUN-2023, an unknown time after receiving Kinrix, the patient experienced extra dose administered (Verbatim: Kinrix unintended extra dose). The outcome of the extra dose administered 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 Information: GSK receipt date: 28-JUN-2023 Nurse called to report a patient received another dose of Kinrix by mistake 10 months after the first dose.  Consented to follow up via email. This case is linked to the case US2023089770, reported by the same reporter.; Sender's Comments:  US-GSK-US2023089770:Same reporter, same event, different patient (twin)
(R) arm injection site red, swollen, warm to touch, area of swelling approximately 2x6 cm, pt states he first noticed it the morning after his injection. Pt instructed to apply cold packs and take an anti-inflammatory and lift affected arm pt instructed to lift arm and return if no improvement
Low grade fever, chills, aches, headache. Took tylenol and rested.
This spontaneous report as received from a licensed practitioner nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored PEDVAX HIB (lot#, strength, dose, frequency and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax 6OCT93 & adm to hosp 2NOV93 w/c/o pleuritic lt sided chest pain; pericardial friction rub was noted on physical exam; electrocardiogram showed new diffuse ST elevation & t wave inversion; mild EKG changes remained;
pt recv vax NOV95 & 2APR96 pt exp chicken pox w/150 vesicular lesions distributed throughout body;pt not sick enough to recv APAP;pt recovered;MD reported 2 other pt who devel varicella following vax;