chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The next day that evening, I started to make a squeaky wheeze.  I woke up feeling  extremely short of breath. I was unable to walk even a few feet without feeling SOB.  I called my doctor and did a virtual visit. I was prescribed antibiotics and steroid pack (Methylprednisolone) for possible pneumonia. On 3/15/2021, I was still feeling horrible and was instructed to go to ER and was admitted for 3 days.  The did blood work (normal) and X-ray of lungs which showed fluids in lungs. I was put IV of Lasix to get rid of fluids. When I was discharged with a diagnosis of heart failure and to follow up with my cardiologist who did an ECHO and stress test- it showed reduced ef rate of 25.  I still have continuing heart issues and on new medications- Lasix and Entresto.
One week after getting injection a red spot appeared at the site approximately the size of a 50-cent piece. From that point forward every day something changed the redness got bigger it was swollen up off the skin kind of like a hive. There was a red and purple line that went through the injection site. It continued to grow I contacted my primary care doctor. He put me on Keflex 500 mg three times a day. The site continued to grow at this point it was measuring 8 in wide by 7 in high. Contacted my doctor again. He wanted to see me his nurse practitioner who did not know what was going on for sure then I was started on doxycycline 100 mg twice a day and prednisone 20 mg twice a day. After 2 days it stopped growing. They told me if it grew anymore after 2 days I had to go to the hospital. The area did not hurt until about 3 weeks after getting the injection one night it woke me up in the middle of the night very painful. The redness continued for a month. There is still a whitish red area at the injection site on my arm. My arm from where it was swollen has a discoloration to it the redness has went away. It kind of looks like a faded bruise.
Pt. received MMR, PREVNAR & Hep A 8-21-12. On 8-23-12 pt. ran a fever of 102 degrees-102.5 degrees & started shaking, pt. was taken to local ER; & 8/24/12 was brought to our clinic - dx: febrile seizure duration x 4 minutes.
The patient received a COVID vaccine at an outside facility, and the next day developed malaise and fevers, and then progressively orange urine over the ensuing 3 days, presented to our ED in acute renal failure and early hepatitis, over ensuing several days rapidly progressed to profound renal failure requiring HD and severe hepatitis. Renal biopsy confirms Rapidly Progressive Glomurulonephritis with crescents, however all serological testing is negative (negative ANA, ANCA, anti-GBM, etc).. We have no etiologic driver of the RPGN in terms of standard vasculitis or autoimmune testing.  On immunosuppressives.
Information regarding Prevnar was received from a pediatrician regarding a patient who received a third dose on an unspecified date and in December 2004 developed pneumococcal bacteremia. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. The patient received a third dose of Prevnar on an unspecified date. In December 2004, a blood culture was performed which was positive for Streptococcus pnuemoniae. On an unspecified date the infant was hospitalized with a diagnosis of pneumococcal bacteremia. After approximately two days of hospitalization, when the fever subsided, the patient was discharged. Treatment included 10 days of antibiotic therapy. The reporter indicated that the infant recovered. The reporter stated 1 or 2 infants experienced this event Additional reports will be generated when identifying information is provided. No additional information was available at the time of this report.
Initial misuse report received from a healthcare professional on 21 January 2013. The cases were received on 21 March 2014 at agency. A 11-years old child patient received; FLUZONE INTRADERMAL (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
IPOL vaccines that was 8 weeks expired had been accidentally administered to a child with no adverse event; Initial information received on 12-Dec-2022 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves Child and unknown gender patient and the reporter reported IPV (VERO) [IPOL] vaccines that was 8 weeks expired had been accidentally administered to a child with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect IPV (VERO) Suspension for injection (batch lot number, strength, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had a non-serious event of ipol vaccines that was 8 weeks expired had been accidentally administered to a child with no adverse event (expired product administered) (unknown latency) following the administration of IPV (VERO).  Action taken with poliomyelitis vaccine (inactivated) (IPOL) was not applicable.  Outcome: Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recv vax 18FEB98 & same day 18FEB98 pt exp a rash from head to toe;the next day 19FEB98 pt devel an anaphylactoid rxn & was brought to ER & kept overnight;
Severe Fatigue, Sore Joints and Muscles, Nausea, Dizziness and head aches
Medical History: severe anaphylactic shock requiring intubation related to rattlesnake bite August 2019.  On September 2019, I went to the dentist and received septacaine, mouth and face swelled up immediately. Toxicologist said this was due to me still being in a "cytokine storm."    12/22/2020- I received my COVID-19 vaccine by Moderna. Within 5 minutes of me receiving the vaccine I first experienced tachycardia, felt my heart pounding,  dizziness, and tunnel vision.  Three hives, dime sized, appeared on my chest within 10 minutes of the vaccine. I felt difficulty swallowing (may have been anxiety related). The dizziness was intermittent for the next hour. I took 25 mg of Benadryl 15 minutes after the shot.  My blood pressure was elevated for an hour, 170s/100 s, Osat maintained above 94%, and heart rate 80s-90s. My resting HR and BP are 100s/60 and HR 61.  I also started to feel bloated and burping. An hour and a half after the shot, the symptoms resolved and I drove home
I am having joint pain through-out my body.Especially, elbows, neck and lower back.Extreme tiredness; I am having joint pain through-out my body.Especially, elbows, neck and lower back.Extreme tiredness; This is a spontaneous report from a contactable consumer (patient herself). A 61-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8739; Expiration Date: unknown) via an unspecified route of administration, administered in Arm Left on 01Apr2021 12:00 (at the age of 61-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included drug hypersensitivity (allergy to sulfer based drugs) from an unknown date and unknown if ongoing. Concomitant medications included thyroid medication (not specified any medicine/drug). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On an unspecified date in May2021 patient reported that she was having joint pain through-out her body especially, elbows, neck and lower back and had extreme tiredness. AEs resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient had received treatment for AEs. The patient underwent lab tests and procedures which included SARS-COV-2 test (Nasal Swab; Rapid test) post the vaccination on an unspecified date in Apr2021 which was negative. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Breakthrough case admission after 2 vaccines Moderna 5/8/21 Lot# 003C21A;  Moderna 6/5/21 Lot# 049C21A
Patient given vaccine with beyond use date of 4/14/2022 on 4/19/2022.   No injury was reported from patient. Refusal of re-vaccination.
Neuropathy in one leg; This is a spontaneous report from a contactable Physician via Pfizer .   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced neuropathy in one leg on an unspecified date with outcome of unknown.    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 event neuropathy peripheral and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
difficulty swallowing; difficulty breathing; a little swelling in the throat; This is a spontaneous report from a contactable consumer (patient). An 81-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 16:30 as SINGLE DOSE in Arm Right for covid-19 immunisation.  Medical history included He has seasonal allergies and sneezes. He does not take medication for it.  It has been diagnosed 3-4 years ago.  It is not real bad. Concomitant medications included atenolol taken 10-15 years, amlodipine taken for 10 years, both for high blood pressure. Prior Vaccinations (within 4 weeks) was none. AE following prior vaccinations was None.  Vaccination facility type was Clinic. After 5-6 hours after the first injection he developed difficulty swallowing, a little difficulty breathing and a little swelling in the throat on 11Mar2021. When he took first shot, there was no reaction until 5-6 hours later.  He had trouble swallowing at 21:30-22:00. He was concerned about these side effects and whether he should receive the second shot.  NO ER or physician's office required. The outcome of a little swelling in the throat was recovering, of other events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Started with scratchy throat on Monday, felt sluggish all day-by Tuesday morning I was running fever and body was reddish.
Information has been received from a physician concerning a female patient about "50 to 59 years of age" who on an unspecified date, was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# and dose not reported). The physician reported that the patient had an injection site reaction on ZOSTAVAX (Merck). On an unspecified date, the patient had a lot of irritation and swelling around the injection site. The physician stated that the patient had never had that happened before and the patient was not worried about it since it resolved on its own. The physician also showed her the product information (PI). No labs/diagnostics studies were performed. The patient just called into the office, and the physician did not think that the patient was even seen. No further information is available.
Cellulitis at injection site and was seen for a follow up on 8/3/2015 and had improved.
Started with achiness just before midnight (after having sore arm all day, but not troubling), woke with fever/chills/headache about 1am and unable to sleep well 1-6am, slight nausea 4-8am, still ongoing achiness all over body and just ill-feeling and fatigue (currently 11am day-after vaccine)
Redness spreading down right arm. Skin feels hot to touch. Fever x 2 days. + arm pain
Covid arm occurred 1 week after shot.  Swelling and large rash and swelling
Given extraneous 4th dose of HepB as parent provided historical immunization history, showing three previous HepB doses, after vaccine was administered.
Prescriptions of Shingrix for patients younger than 50 years old; Prescriptions of Shingrix for patients younger than 50 years old; This case was reported by a pharmacist via call center representative and described the occurrence of product prescribing error in an unspecified number of patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced product prescribing error and inappropriate age at vaccine administration. On an unknown date, the outcome of the product prescribing error and inappropriate age at vaccine administration were unknown.  Additional information was provided as follows: The age at vaccination was not reported but could be lesser than 50 years old. The pharmacist reported having received prescription of Shingrix for patients younger than 50 years old, which led to product prescribing error and inappropriate age at vaccine administration. The reporter did not consent to follow up. No further information was provided. This case had been linked with US2020083387, reported by same reporter.
This case reported by a other health professional and described the occurrence of wrong vaccine administered in a 13-year-old male patient who received HAVRIX 1440 (batch number Y4R59, expiry date 7th March 2016). On an unknown date, the patient received HVRIX 1440. On an unknown date, an unknown time after receiving HAVRIX 1440, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received: 13 years old patient inadvertently administered HAVRIX 1440.
Chills and body aches.  Then, at 6:00pm, fever begins 100 degrees, 102.5 at 10:00pm, broke at 1:00am
STARTED VIVOTIF LESS THAN 2 WEEKS PRIOR TO TRAVEL; This spontaneous case (PVX2019-1099) was received from a consumer on 03-May-2019. It describes a 36-year-old female consumer who "started Vivotif less than 2 weeks prior to travel". The consumer was receiving oral Vivotif (one dose every other day; lot number: 3003275) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 02-May-2019. She had a planned travel to an endemic area on 06-May-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "started Vivotif less than 2 weeks prior to travel" was unknown.  Company's Comment: The causality of the event "started Vivotif less than 2 weeks prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "started Vivotif less than 2 weeks prior to travel" was considered as not applicable.
Flu like symptoms, headache, tired. This lasted two days, the after five days I developed a rash on my ankle.  Weeping, itchy, inflamed.  The rash spread to my torso, chest, back, lower legs and then upper legs.    Heat would cause the symptoms to increase.  Called physician six days after vaccine. He prescribed prednisone and zertex.
Itching; Paining; 2nd shot knocked me off my feet; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles twice on back). Previously administered products included Shingles vaccine with an associated reaction of pruritus (received 1st dose on an unknown date and experienced itching and pain, refer case US2022AMR066755).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell, pruritus and pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feeling unwell was recovered/resolved and the outcome of the pruritus and pain were not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, pruritus and pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR066755   Additional Information: GSK Receipt Date: 18-APR-2022  Reporter's Comments: This case was received from the patient via interactive digital media. The patient got Shingles shots and still had itching and paining years after. The patient mentioned that the second shot knocked him/her off feet for three days, but well worth it if it worked. Additional Supportive Information: The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR066755:Same reporter
RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 58 year old male. 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 not reported,  batch number: 1822809 expiry: 07-MAR-2022) 2.5 ml, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-NOV-2021, the patient experienced received 2.5 ml of the janssen covid-19 vaccine. On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219731, 20211219686, 20211220537, 20211219807 and 20211220948.
Information has been received from a physician's assistant concerning a 13 month old female patient who on an unspecified date was vaccinated with 0.5 ml of dose of MMR II (lot not required). On the same visit the patient also received VARIVAX. Subsequently the patient developed rubella and measles type rash all over the body and fever above 101 degree. Additional information has been requested.
I received the second dose of the Moderna vaccine at 10:30 in the morning on April 8th. When I awoke the next morning (approximately twenty-four hours after receiving the shot) I had a rash (a bright pink, itchy rectangular patch approximately 6 inches long by 5 inches wide) extending from just above the elbow to just below the injection site on my right arm. April 18th ? It is day ten of the rash on my arm.  It doesn?t seem to be as bright pink and it isn't quite as itchy, but it still itches to the touch (although I have not been scratching it). I haven't done anything to treat the rash; I am hoping that it will disappear by itself.
arm swelling; Injection site pain; redness; heat to the touch from her elbow to her shoulder; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 67-year-old female patient who received Herpes zoster (SHINGRIX) for prophylaxis.   Co-suspect products included PNEUMONIA VACCINE for prophylaxis.   On 28th July 2020, the patient received the 1st dose of SHINGRIX and PNEUMONIA VACCINE. On 28th July 2020, less than an hour after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, erythema and feeling hot. The patient was treated with ibuprofen and non-drug therapy (Cold Compress). On 30th July 2020, the outcome of the extensive swelling of vaccinated limb, injection site pain, erythema and feeling hot were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, erythema and feeling hot to be related to SHINGRIX.  Additional details were reported as follows: The patient received a dose of SHINGRIX and pneumonia vaccine in her left arm on the same day. She stated that she developed injection site pain, arm swelling, redness and heat to the touch from her elbow to her shoulder within one hour of receiving these vaccines.  The symptoms resolved two days later after she treated herself with ibuprofen and cold compresses.  The reporter had no information for the pneumonia vaccine. The reporter consented to follow up.
light headed, extremely tired, shortness of breath, elevated pulse, and increased pain around the hip replacement
This initial spontaneous report was received from a registered nurse (also reported as from a medical assistant) referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on unknown dates, the patients were administered improperly stored doses of PEDVAXHIB injection (lot # K026532 with expiration date 07-AUG-2017, lot# L012837 with expiration date 11-MAR-2018, Lot # L030869 with expiration date 068-JUN-2018; dose and route were not provided). No adverse effects were reported. It was unknown of the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient states that she had swelling, soreness, tingling to fingers and forearms, in both arms and hives to back, both arms and thighs approximately one day after receiving MCV4 vaccine.
I have bipolar disorder. I received my first vaccine on 2-16-2021 and the second on 3-16-21. On 3-21-2021 I began what ended up being the most intense, lengthy, and suicidal crash I?ve ever experienced. It lasted from March all the way through October2021. There was no trigger and no ramp up. On 3-21-2021 at 3pm it?s as though a switch was flipped and all of a sudden my function was altered. I normally deal with bipolar disorder chronically but the speed and intensity of this episode including rapid cycling and complete sleeplessness   was unlike anything I?ve ever experienced. On 1-10-2022, I received my booster and now I am experiencing the  exact same symptoms.  As a life saving measure, I know I had to take the vaccine and subsequent booster, but the mental health side affects for me are rather intense.