chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had the Shingles Shot and still got them/Suspected Vaccination Failure; Still got them; Really painful on my right side and back; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the Shingles Shot and still got them/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: Still got them) and pain (Verbatim: Really painful on my right side and back). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-MAR-2023 The case was received from the patient interactive digital media. The patient had the Shingles Shot and still got them.  The patient stated that it was really painful on his/her right side and back.  The patient had a pain cream that he/she had rubbed on every night. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
11-22-10 patient reported to daughter tremors (shakes) to hands & feet. Treated with TYLENOL PM. Daughter administered 25mg BENADRYL & checked in at E.R. While waiting in ER, symptoms cleared up. Patient left E.R. untreated - patient is doing fine.
Genital warts; The patient was administered Pneumovax in February 2005 and October 2005; This spontaneous report has been received from other healthcare professional via a medical records from a case in litigation for zoster vaccine live (ZOSTAVAX)(2102USA003524), concerning a 52-year-old female patient (pt). The pt was a smoker. She was allergic to codeine, cephalexin and sulfa drugs. Her concurrent conditions included transverse sinus thrombosis, hypercoagulation with anticoagulant therapy, depression, astroesophageal reflux (GE) disease, lumbar spinal stenosis (LLS), obesity, hirsutism, allergic rhinitis, pernicious anaemia, iron deficiency anemia- malabsorption. The pt's family history included coronary artery disease (CAD) and cystic fibrosis. The PT' medical history included pain in left elbow, gastric bypass, anxiety, peptic ulcer disease (PUD), peripheral edema, furuncle, chronic low blood pressure, left lower extremity (LLE) radiculopathy, cholelithiasis, jaundice and rotator cuff strain. The patient received doses of unspecified influenza vaccines on unspecified dates in: November 1992; September 1993; October 1994; November 1995; November 1996; October 1999; November 2000; November 2001; October 2002; September 2003. It was also reported that the pt was vaccinated in the past with tetanus (+) diphtheria (+) pertussis (Tdap) vaccine (on 01-AUG-2003).  On an unknown date in February 2005, the pt was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX). On an unknown date in October 2005, the pt was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) for prophylaxis (dose, route of administration, anatomical location, lot# and expiration date were not provided for both)(inappropriate schedule of vaccine administration). On an unknown date in November 2005, the pt experienced genital warts. The outcome of the event of genital warts was not reported.  The causality assessment between the event of genital warts and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) was not provided.  All available medical records will be provided upon request.  This is the one of two cases regarding the same patient (linked: MARRS#2102USA008735).; Sender's Comments:  US-009507513-2102USA003524:
Pt vax; 24 hrs later devel tachycardia & increased blood pressure.
Pt describes "like a heat rash that started around both wrists about 2 days after vaccine receipt".  Received multiple vaccines on Saturday (5/3/08) and rash appeared on Monday (5/5/08) as well as his wife noted that his right eye was little puffy.  Pt said by Wednesday (5/7/08), the right side of his face was swollen and his right eyelid was almost swollen closed.  He still had a rash on his arms and also had a rash around his right eye and on the right side of his nose.  He denies any local reactions.  (Some of vaccines given in right upper arm and remainder given in left upper arm.)  He denies any fever, chills, joint pain, headaches, fatigue, rhinorrhea, itchy or swollen throat, swollen tongue, difficulty swallowing, dyspnea, cough, sneezing or wheezing.  No visual changes, facial drooping or slurred speech.  Pt went to his local doctor on Wednesday (5/7/08) and received a steroid shot and was prescribed a MEDROL pack and ZYRTEC.  The right sided facial swelling was completely gone by Saturday (5/10/08) and the rest of his symptoms resolved by the following Monday (5/12/08).  He denies any exposures around time of vaccines like yard or work-related chemicals, detergents, bug sprays, soaps, insect bites, new foods, cleansers, lotions, new clothing or bed linens, or household chemicals.  No history of similar rashes or adverse vaccine reactions.  Will not be deploying until April 2009; will not have drill until Sept 2008.  Pt currently has no symptoms.
SYMPTOMS starting 01/18/21 6p chills,fever 100.0, fatigue ended 01/20/21 3p
Pt states had severe reaction to vaccine; next morning woke up with nausea, got on a plane to fly out, prior to it got leg and joint pain, nerve pain, sneezing, coughing, diarrhea; went to airport; 9.5/10 pain. Had flu shot her entire life but this one had reaction; 2nd day pain went away but still feeling sick.
Fever; Arm was very swollen; Arm red; Arm was hot; A lot of pain; This case was reported by a nurse via call center representative and described the occurrence of fever in a female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine at an unknown dose. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced fever, swelling arm, erythema of extremities, skin warm and pain. On an unknown date, the outcome of the fever, swelling arm, erythema of extremities, skin warm and pain were unknown.   It was unknown if the reporter considered the fever, swelling arm, erythema of extremities, skin warm and pain to be related to Tdap Vaccine.  Additional information received were as follows: The age at vaccination was not reported. The manufacturer, lot number and expiry date was unknown. The nurse on the line reported that she had a really strong reaction to Tdap 10 years ago. The patient experienced fever, her arm was very swollen, red, and hot and she had a lot of pain, which was more than normal. The reporter did not consent to follow-up. The caller did not had time to complete full safety report.
We report an event of transverse myelitis occurring one week after second dose of COVID vaccine in a seventy-five-year-old previously able-bodied gentleman with HTN and DM2. He developed a painless, distal greater than proximal, subacute onset weakness of the right greater than left upper and lower extremities with bowel and bladder retention. He was treated with methylprednisolone IV q24h for 3 days and IVIG (divided over 3 days). At one month from symptom onset, he was able to walk, but continued to have urinary and fecal retention. By 60 days since symptom onset, he had near resolution of symptoms.
Initial unsolicited report received from a nurse on 08-Jun-2017. This case involves a 46-year-old female patient who was vaccinated with a dose of YELLOW FEVER VACCINE - US (YELLOW FEVER) (batch number: UI606AA, dose and route of administration was not reported), in the left post arm on 05-Jun-2017. The patient's medical history and concomitant medications reported as none. On 08-Jun-2017, three days following the vaccination, the patient developed itching and had a mildly red back of her arm and an indurated area of 4 by 5 is planning to watch the patient and monitor the site. The patient required ER/doctor visit. The patient's laboratory data and corrective treatment reported as none. At the time of report the patient was not recovered from the events. List of documents held by sender: none.
FLU-LIKE SYMPTOMS CHILLS, MUSCLE SORENESS, HEADACHE AND ACHY SKIN; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included clotting disorder (unknown cause, with two episodes of clot prior), chronic migraine, celiac disease, penicillin allergy, cephalosporin allergy, sulfa drugs allergy, and social drinker (once every few months). The patient experienced drug allergy when treated with tetracycline, and vancomycin non-company for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 14:15 in left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced injection site pain. On 15-MAR-2021 22:00, the subject experienced flu-like symptoms chills, muscle soreness, headache and achy skin. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient was recovering from flu-like symptoms chills, muscle soreness, headache and achy skin, and injection site pain. This report was non-serious.
Woke at 4:30 am shivering and cold.  Checked my temperature later and had 99.1°.
I had swelling and redness that kept getting bigger.  The injection site was hot like it was almost infected.  I had it checked out at the walk in clinic and they said it was an allergic reaction and to take Benadryl along with icing the arm.  I was not the best at following this but once I started doing this is started to get better and was cleared up within a week.
Sudden numbness, dizziness on and off, numbness receded.  Pt encourage to stay but refused and left facility.  Instructed to follow up with PCP.  1520 BP 108/58, HR 76, OSat 98% 1540 BP 110/64, HR 76, OSat 97%
BLOOD CLOT; This spontaneous report received from a consumer concerned a 76 year old male. The patient's weight was 82 kilograms, and height was not reported. The patient's past medical history included angina pectoris, peptic ulcer disease, and tension headache, and concurrent conditions included asthma, atherosclerotic heart disease of native coronary artery, benign hypertension, stage 3 chronic kidney disease, chronic obstructive pulmonary disease with acute exacerbation, cirrhosis of liver, diabetes mellitus type 2, generalized osteoarthritis, morbid obesity, mixed hyperlipidemia, stenosis of bilateral carotid artery, peripheral vascular disease, malignant neoplasm large intestine, carotid artery occlusion, and hepatocellular carcinoma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: cabozantinib s-malate (tablet, oral, batch number was not reported) 40 mg, 4 times every 1 day, from 04-MAR-2021 for hepatocellular/liver cancer. Concomitant medications included apixaban, atorvastatin calcium, carvedilol, ergocalciferol, hydrocodone bitartrate/paracetamol, levothyroxine sodium, losartan potassium, mecobalamin, metformin hydrochloride, salbutamol sulfate, tadalafil, tamsulosin hydrochloride, and vitamin b complex.  On 03-APR-2021, the patient experienced blood clot. On an unspecified date in Apr-2021 the patient was hospitalized for one day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210530464-covid-19 vaccine ad26.cov2.s-Blood clot. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS, MEDICAL HISTORY
Severe Tinnitus in left ear.  Has continued since a day or two after vaccine.  No improvement.  Tinnitus causes headaches.  Unable to sleep.  Tinnitus is constant with no relief.
Rapid heart rate, chest tightness and pain, shallowness of breath, dizziness, cold sweating.  Total time 12 hours from adverse symptom onset; symptoms lasted for 5min at a time and occured at intervals every 2-3 hrs.
Pt recvd 2 doses of Engerix-B & devel rash & itching 48 hrs p/1st dose; resolved;
Shortness of breath; pneumonia due to COVID-19 virus; acute respiratory failure with hypoxia
Arm soreness at the site of injection. Not major or debilitating, but noticeable; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247 and expiration date: unknown.), via an unspecified route of administration on the left arm at the age of 34 years old on 04Feb2021 at 15:00 at a single dose for covid-19 immunisation. Patient is not pregnant. Medical history included allergies with sulfa drugs and acne. Concomitant medication included spironolactone for acne. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced arm soreness at the site of injection; not major or debilitating, but noticeable on 04Feb2021 at 16:00. No treatment was received in response to the event. The patient assessed the event as non-serious. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the event was recovering.
Pt states having a headache and feeling dizzy since receiving the vaccination on Tuesday 08/22/23. Pt denies nausea, no vomiting, no syncope, no fevers and no problems with swallowing. Denies any throat swelling only continues to state, "I have a headache and feel dizzy". Pt also states that her mother noticed she looked pale yesterday (08/23/23).  Pt has been able to keep foods down and states drinking fluids throughout the day.  Discussed with patient common side effects from the Tdap vaccine can include headache, body aches, and possible mild fevers. Encouraged pt to drink water to help with hydration and headache. Discussed with pt she can also take OTC Tylenol or ibuprofen as directed from packaging for mild symptoms' relief. Pt states taking ibuprofen on Tuesday 08/22/23 with no relief of headache. Discussed to also take a COVID test to check status. ED precautions given and encouraged since pt is continuing to have her symptoms. Pt verbalized understanding and agreed to follow up with ED for further evaluation.
Each time was after getting a flu shot; Initial information was received on 24-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves a patient with unknown demography who each time experienced flu was after getting INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza), unknown latency following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown.  There will be no information on the batch number for this case.
Severe swelling under the arm, at injection site and redness and painful areas around the chest and upper back.
16FEB99 pt recv vax & 17FEB99 local reaction 4cm pink-swelling rt thigh not tender;happy playful;impression: local reaction. A nurse reported that a 7-month-old female received HIB-TITER and ACEL-IMUNE vaccines on 16-FEB-1999. On 17-FEB-1999, she developed an injection site reaction chactererized by a 4 cm area of redness, swelling and warmth at the HIB-TITER injection site. The infant recovered without treatment. This is 1 of 4 patients from this facility who had an advers experience following receipt of HIB-Titer lot 361503A. "Follow-up information received from the provider supplied the patient's name and lot number for ADEL-IMUNE. This report had been submitted directly to VAERS (Ref No. 119479)."
shingles; Information has been received from a lawyer concerning a case in litigation and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. In 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route, vaccination site, lot # and expiry date were not specified) for the long-term prevention of shingles and zoster-related conditions, as prescribed and/or administered by a healthcare provider. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The causality was related.
We have some past expiration administrations that have surfaced; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced). On 13-May-2021, EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The days of post expiry is reported to be 15 days. It is also reported that the event occurred 6 months ago from the date of e-mail receipt (18-Nov-2021).  No concomitant medications were reported.  No treatment information was provided.
Administration error - Patient was given the COVID-19 Janssen vaccine at 17 years old (only approved for >/= 18 at this time). No adverse reaction has been observed or reported at this time.
patient got nerve problems in his face, lips, tongue and then his eye and started drooping/talking like his face was paralyzed; This is a spontaneous report from a contactable consumer. A male patient (reporter's brother) of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date not reported), via an unspecified route of administration, administered in the left arm on Feb2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported.  Historical vaccine included first dose of bnt162b2 on an unspecified date at single dose for COVID-19 immunization. On Feb2021, the patient got nerve problems in his face, lips, tongue and then his eye and started drooping and stayed like that as of today and was talking like his face was paralyzed. Clinical outcome of the event was unknown.  Information on lot/batch number has been requested.
Information has been received from a registered nurse concerning a 16 year old female who on 23-MAR-2009 was vaccinated SC with VARIVAX (lot #662459/1784X) into the left arm. On 24-MAR-2009 the patient developed 2-3 inch area of redness, swelling, and warmth at injection site. The patient called the office and was prescribed cool compresses, MOTRIN and BENADRYL. This is one of several reports form the same  source. Additional information has been requested.
fever devel AM p/vax given 7JUN96;also fussy, t103 to 104 for 4 days approx fever resolved 11JUN96 PM; poss pertussis rxn
Patient received tetanus (Td) 4/4/06. Has experienced increase arm pain (awakening her at night), induration, warmth and swelling at site of injection.
abscess formation at injection site treated with Bactrim x 10 days on 4/23/08
got sick for One day; This case was reported by a consumer via  interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received dose  in 2014) and Shingles vaccine with an associated reaction of illness (1st dose received on an unknown date, refer case US2021AMR113617).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. Two weeks ago patient had received 2nd dose of shingles vaccine and got sick for 1 day. The reporter reported that was some thing the older people needed and yes older people need. The follow up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR113617:same reporter, same pateint, same AE, different dose (1st dose)
low grade temp 12NOV98 101 13NOV98-15NOV98 T103;15NOV98 rash on back/chest/forehead, APAP & motrin given @ intervals eating & drinking well per mom;