chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pharmacy administered pneumonia, flu / flu like symptomssuspected vaccination failure; flu like symptoms; felt extremely rundown; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and 10PN-PD-Dit (Pneumococcal vaccine) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml, Influenza vaccine Quadrivalent unspecified season and Pneumococcal vaccine. On an unknown date, not applicable after receiving Shingrix and Pneumococcal vaccine and less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza-like symptoms and tiredness. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza-like symptoms and tiredness were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and tiredness to be related to Shingrix, Influenza vaccine Quadrivalent unspecified season and Pneumococcal vaccine. It was unknown if the reporter considered the vaccination failure to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The patient's demographics were not reported. The pharmacy administered pneumonia, flu and Shingrix  vaccine at the same time to the patient and patient felt extremely rundown with flu like symptoms for multiple days. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The reporter did not agree to follow up.
Mom called 3/3/03. Stated in 3/1/03 child started breaking out w/chicken pox x 3 of the day that gradually went to 30 total in belly legs, some crusted over already.
Extreme hot flash that felt like needles all over the body, knees  felt like they were on fire, lips and tounge were  tingling, bad taste in mouth, elevated blood pressure and heart rate, and dizzy.  Dissipated after about 30 minutes, and left a headache.
DID NOT COMPLETE HER IMMUNIZATION ONE WEEK PRIOR TO TRAVEL; TOOK AN UNREFRIGERATED DOSE; This spontaneous case report was received from a consumer (PVX2019-312) on 04-Feb-2019. The report describes a 54-year-old adult female consumer who "took an unrefrigerated dose" and "did not complete Vivotif doses one week prior to travel". The consumer was receiving Vivotif (lot number: 3003240 and expiry date: Nov 2019) for travel.  It was reported that the consumer took the first dose of Vivotif on 03-Feb-2019, which was unrefrigerated for 5 days. The consumer also stated that she will be arriving on 14-Feb-2019.  The action taken with Vivotif with respect to the events "took an unrefrigerated dose" and "did not complete Vivotif doses one week prior to travel" was not applicable.  The clinical outcome of the events "took an unrefrigerated dose" and "did not complete Vivotif doses one week prior to travel" was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose" and "did not complete Vivotif doses one week prior to travel"" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose" and "did not complete Vivotif doses one week prior to travel"" was considered as not applicable.
Patient reports right should and area around the injection site got itchy and she got a few hives within a couple hours of the injection. Pt states that she took Benadryl and went to bed, and when she woke this morning, it was fine.
Patient reacted with rash to body spontaneously. Resolved after Zyrtec (RD) 1g/ml, 1.5 tsp. Patient recovered.
Small area of pain, redness upper arm (deltoid) HA significant "lump" left worsening since Tdap administer.
Administered expired vaccine to patient, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses. The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant follow-up appended reporter details added.
This spontaneous report was received from a pharmacy intern refers to a patient of unknown age and gender. No pertinent medical history was reported. On 21-NOV-2014, the patient was inadvertently vaccinated with PNEUMOVAX 23 (lot # J007786 and expiration date was 25-SEP-2014) (strength, dose and route were not reported) which was expired on 25-SEP-2014. Also reported the dose was supported. Concomitant therapy was not reported. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
9/16/21: Patient arrived to ER due to shortness of breath. Patient was discharged from our service on 09/09/2021 after being managed for COVID-19 infection and UTI.  Patient was discharged on Keflex. Patient states that she was improving but then yesterday she started having acute shortness of breath that started at rest.  She checked her O2 sat levels and it was 82%. Shortness of breath is worsened with movement, improved after administering supplemental oxygen in the ED. shortness of breath is associated with a generalized weakness, dry cough and chills.
Aching, chills, and fever began about 9:30 PM and continued through the night until about 6:00 AM Saturday, February 13. I was tired the rest of the day from the fever but otherwise OK.  No further problems until today (Monday, Feb. 15). I have a ringing in my left ear but I have no reason to believe that is related to the vaccine. You might but I don't.
pt recv vax 7JMAJR95 & exp an inj site rxn described as red & swollen;recovered;last Td vax JUL82
Area has localized erythema, discomfort, and itching in shoulder; arm and neck aching.
No adverse event; Bivalent doses administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) in a 36-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 20-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patient) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patient).    Concomitant medication was not reported. It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. 113 Bivalent doses administered after the BUD to patients 12 and up. Breakdown of doses were reported as 51 doses from Lot AS7140C, and 60 doses from Lot AS7148B.   Treatment drug was not reported.   This case was linked to (E2B Linked Report); Sender's Comments:
Diffuse myalgia, numbness in extremities, symptoms persist 4 weeks after 3rd dose of vaccine. No such symptoms after first or second dose.
5/16/2015: Saturday had hives and itching on hands/feet and abdomen. Hives, mostly on feet and hands, some on upper abdomen. Hands and feet are red and slightly swollen. 05/17/2015: Saturday, throat red, raw, sore, malaise, headache, body aches. Sunday, temp up to 101-102. 5/18/2015: Woke today very diaphoretic, sheets were soaked.
Extreme Hive Break Out for three days.  Extreme Lip Swelling.  I have plenty of pictures if you want them.  We went to Emergency room on Friday and they gave her an IV with Antihistamine and Steroids and Pepcid.  She got better and we went home.  She broke out again all over her body on Saturday and this time we went to Emergnecy room.  They observed her and basically told us when they discharged us to keep her on Benadryl every four hours for the next 48 hours.    I think it's important to note that she did test positive for COVID 19 on December 11, 2020 and had a fairly mild case of the virus.  ALso, that she has never had this reaction to anything ever before.
One day prior to the clinic on 5/18/22, an email was sent to the pharmacy with a list of patients that needed boosters. At the start of the clinic on 5/19/22, copies of vaccine cards for these patients were given to the pharmacy staff. All cards were checked by the pharmacy to ensure eligibility for boosters. Vaccine administration started at 1pm. At approximately 1:20pm, after 14 vaccines were given, a person alerted the pharmacy that the copies of vaccine cards and emailed list were not up-to-date. After consulting with that person who had an updated list of vaccine records, it was determined that six patients were given a booster shot when not eligible. Consulted with the pharmacy team on how to follow-up and proceed with the clinic. Going forward, each patient vaccinated had their records verified on the system and online. Emailed list was cross-checked with the updated list. Even with updated list from facility, errors were found with vaccine records not being up-to-date and inconsistencies. Photos of covid vaccination cards were taken for records and vaccination cards were sorted.  Patient recieved second booster but did not qualify for second booster.
My daughter blacked out immediately after the vaccination, nausea, weakness in her limbs, continued headaches, severe rash on her face
After receiving Gardasil, pt on bedside table. Nurse Sat to document injection and patient fell from bedside table to floor face first. LOC 30 seconds. Large lemon size hematoma middle of forehead. Pt oriented to place and person. Mom at side. MD called to bedside. VSS. See flowsheet. Ambulance called and pt transported via ambulance to ED.
Patient has injection of both sclera.  Right is worse than the left.  No discharge from eyes.  Eyes are itchy.  No lid edema.  No other signs of allergy.  No sick contacts.  Looks like allergic conjunctivitis but he has no history of seasonal or environmental allergies.  Advised mom to use allergy eye drops.  Outcome unknown at this point.  Patient seen today.
Itchiness at injection sites, redness, swelling, warmth. Tx: Benadryl elixir, Triamenalone 01%, ibuprofen elixir.
10/26/2021 in the afternoon after 4:43PM I got my vaccine. After 6 hours I felt nausea, body aches, fever, chills. I took Tylenol and Motrin as needed every 4-6 hours. I alternated 2 medications. I took cough syrup. I called out of work for 2 weeks. I can't sleep in the night. I went to my doctor and he prescribed me with two inhalers which are Flovent HFA 110 mcg, Albuterol sulfate 2 times a day. I am still using it. I have whooping cough. It's  been 4 months. I contracted COVID-19  two month between the vaccines. Jan 14/2022 came out positive.
not feeling well; received the first dose of the Pfizer vaccine on 19Mar2021. I received the second dose of the vaccine on 09Apr2021. I tested positive for COVID on 18Apr2021.; received the first dose of the Pfizer vaccine on 19Mar2021. I received the second dose of the vaccine on 09Apr2021. I tested positive for COVID on 18Apr2021.; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 09Apr2021 as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Mar2021. The patient stated that she received the first dose of the Pfizer vaccine on 19Mar2021. She received the second dose of the vaccine on 09apr2021. She tested positive for COVID on 18Apr2021 (also reported as 21Apr2021, pending confirmation). The patient was not feeling well on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 18Apr2021. The outcome of the events was unknown. The patient wanted to know if she can et the COVID-19 infection from the vaccine. She also wanted to know if the vaccine can cause a false positive result. The patient was questioning if she tested positive due to the vaccine.  Information on the batch/lot number has been requested.
This spontaneous report as received from a consumer in his 60's refers to himself. His concurrent conditions included diabetes and allergy to codeine. In February 2014 (reported as "this past February") the patient was revaccinated with second dose of PNEUMOVAX 23 0.5 ml one dose, intramuscularly (injection site, lot# and expiration date not reported). Indication for the vaccination was reported as "diabetic, indicated age for vaccination and scheduled time for revaccination". Time of the first vaccine administration was reported as "about two years ago". Metformin was reported as a concomitant medication. On an unknown date in February 2014, within minutes from injection, the patient experienced fever and shooting pains that went halfway across his collar bone and arm. He also noted that when he slept on that particular arm it would wake him up because of the pain. The patient stated that he had an injection site pain that "felt like the needle was still stuck in his arm"; the pain lasted for a month and he recovered from it on an unspecified date in March 2014. On an unknown dates in 2014 the patient experienced four separate incidents of a high fever (greater that 102F) which caused him to have a seizure and a black out. On an unspecified dates in 2014 the patient also had negative thoughts and suicidal thoughts, felt weaker and had developed bilateral arthritis which caused increased pain in his shoulders, arms, wrist, hands and knuckles. He also complained about decrease limb mobility such as not being able to close his hand fully. The patient sought medical attention via contacting a physician. Unspecified "blood tests" were performed (results unknown). The patient was treated with unspecified arthritic medication and oral prednisone (exact indication not reported). The patient reported that he recovered from "some of the noted adverse events" but did not recover from arthritic pain and decreased limb mobility. Relatedness between use of PNEUMOVAX 23 and reported adverse events was unknown. Additional information has been requested.
Pt. passed out passed out after HPV vaccine administration. I did vitals, but before the vitals pt claimed that wanted to throw up so I grabbed pt and took her to the bathroom. Then after she threw up she passed out. Doctor came and I did vitals after we placed her in room. I monitored her for 30 minutes and after pt claimed of feeling well, she left the facility.
Patient was inadvertently administered the Pfizer bivalent COVID-19 vaccine instead of the monovalent.
This spontaneous report as received from a nurse practitioner refers to a 16-year-old female non-pregnant patient with a history of brain tumours. The patient was allergic to azithromycin causing complete body swelling and cephalosporins causing hives. There were no concomitant medications. On approximately 16-AUG-2017 (reported as 5 weeks before an adverse event onset), the patient was vaccinated with a dose of GARDASIL 9 intramuscularly (dose, lot number not reported). On 20-SEP-2017, the patient broke out in hives from head to toe on, five weeks to the day from receiving a dose of GARDASIL 9. The Nurse Practitioner also reported that the patient had fever, body aches and swollen lymph nodes. The patient was given prednisone intramuscularly and BENADRYL orally on the same day which did not help much. The reporter prescribed oral prednisone and ZANTAC 300mg on 21-SEP-2017. The outcome of the events was reported as recovering/resolving. The events were considered life-threatening by the reporter (reported also as they could lead to the life-threatening event).  The relationship between vaccination with GARDASIL 9 and the events was not reported.
Deltoide (Lt) rojizo, caliente al tacto con mucho picor.  Se administro CIPRO P.O. 1 tab daily.
Pt vaccinated with Meruvax II developed fatigue, fever, adenitis & severe arthralgia, especially of hands & knees. Biopsy revealed lymphoid hyperplasia.  Possible "post rubella immun synd".
was diagnosed with shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 4749N, expiry date 14th November 2021) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix. On 25th January 2020, 87 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The health care professional stated that, the patient received a dose of Shingrix and sometime this weekend the day of reporting diagnosed with shingles. The reporter stated that, till the time of reporting, the patient did not receive 2nd dose of Shingrix. The reporter consented to follow up.
Left arm became warm, red and swollen Monday prn (10/3/05). Didn't check temp but had chills and sweats Monday pm, sluggish yesterday. Today (105.5) area 5"x7" inner left arm with warmth and redness, lower left arm 1"x3" area of redness only. Pt states feels better today.
MEDICATION ERROR - PT GIVEN PEDIARIX (dTAP, IPOL, HEPB) and IPOL.
This 34 y/o female patient received 2nd anthrax vaccination on 6/21/04. She indicated vaccination given mid left tricep region of arm. She has mild swelling and redness to the site 6/22/04 with marked increase in swelling, redness and heat on 6/23/04. The swelling extends mid left arm to elbow posteriorly with lateral and posterior erythemia measured 19x18 cm. Left arm circumference measured 30 1/2cm with right at 29cm. There are 1-2 soft mobile nodules <1mm under the left adnexal (mild lymphadenopathy). She denies paresthesia, fever, weakness or a temperature change to the left arm. She also received her meningococcal #2 vaccination to her right arm 6/21/04 w/o incident.
Case previously recorded as MA2009-3751. Received on 06 Nov 2009 from a consumer the following information: A female patient was vaccinated with H1N1 (manufacturer and batch no. unknown) on an unknown date. The patient experienced on an unknown date pain in the arm (injection site) for about 4 days and achy and cold at night. The outcome is unknown.
Patient with history of Parkinson's and diabetes. He was brought to the ED by EMS after an unwitnessed fall the morning of 1/3/23. The patient does not remember falling, but reports being on the ground and unable to get up. Patient reports increased weakness as well as fatigue, fever, constipation, and leg swelling. A COVID PCR test performed in the ED returned positive. Patient was admitted 1/3/23 - 1/16/23. Discharge diagnoses included acute hypoxic respiratory failure, COVID-19, and suspected aspiration pneumonia with severe sepsis. His pneumonia and COVID-19 resolved during admission, and hypoxic respiratory failure was improved. Patient was found to have low oxygen saturations which required supplemental O2. Oxygen needs were weaned down over time but remained present prior to discharge. Patient was discharged to a HCF for ongoing rehabilitation. The patient has received the primary COVID vaccine series and 3 boosters.
Raised, red and itchy rash about 1.5? in diameter at site of injections appeared one week after shot.  (Exposure to sun). Also, on 4/3 began severe sore throat with redness and jelly-like uvula. No swelling. Ended 4/8. Left untreated.
At around 10 hours after receiving the vaccine, i had noticeable side effects. The worst one was chills. I had sudden and severe chills for several hours. 2 hours later i developed a severe headache, mild nausea, and muscle aches. The next morning, i felt very tired and had moderate muscle aches all day long.
Per husband, was in usual state of health on the AM of 1/10/20, AOx3 able to perform all I/ADLs. At around 2:30pm that day was complaining of chills and generalized malaise. Then at ~9:30pm when husband returned home from work found patient diaphoretic, confused (stating things like "not now, I want to go to lake"), and complaining of chills and weakness. Unable to provide any additional hx regarding other sx.   Initially presented to ED, where mental status had deteriorated to AOx0, unable to respond to verbal commands. Initial vitals notable for T102.6F (unclear other vitals). Patient is now AOx0 most concerning for encephalopathy.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (dose, frequency and route not reported). Concomitant medications were not reported. On an unknown date after receiving ZOSTAVAX the patient developed redness at the injection site. At the time of the report the patient's outcome was unknown. This case is related with MARRS # 1306USA006631. Additional information has been requested.