chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got the shot and still got shingles twice/!Suspected Vaccination failure; got shingles twice!!!; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional information was provided as follows: This case was reported by patient itself. The age at vaccination was not reported. The patient got the shot and still got shingles twice. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation for shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Swelling redness and soreness at injection site; Swelling redness and soreness at injection site; Swelling redness and soreness at injection site; body aches; low grade fever; First dose on 21Dec2020, second dose on 05Jan2021; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 05Jan2021 at single dose for covid-19 immunization. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient had no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EH9899 on 21Dec2020 07:45 PM, at age of 26 years old, via Intramuscular in right arm for covid-19 immunization and experienced itching, nausea, headache, body ache, site soreness and swelling. Medical history included sciatica. The patient's concomitant medications were not reported. The patient experienced swelling redness and soreness at injection site, body aches, low grade fever all on 05Jan2021 with outcome of recovered in Jan2021.  The patient underwent lab tests and procedures which included PCR nasal swab for COVID-19 negative on 04Jan2021. The patient received paracetamol (TYLENOL) 500mg for treatment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient was given the pediatric dose (had pediatric dose for dose #1), turned 12 right before dose #2.  He was given  pediatric dose instead of the adult dose for dose #2.
vaccine given on 7/9/07- pt developed fever/chills T 102 deg on 7/10/07 which resolved after 2 days. She then developed arthralgia, joint aches, myalgias, and a fever of 101.5 again with hives.
Muscle  pain;  joint pain; headache; chills; fever.   Took aleve and OxyContin. Started January 30, 2021- present February 3, 2021
a case of throwing up; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (a case of throwing up) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical conditions reported).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VOMITING (a case of throwing up). At the time of the report, VOMITING (a case of throwing up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. 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.
Pt received covid19 vaccine. Pt was waiting in observation area for about 10 minutes when she began complaining of itchy dry throat, ears ringing, light headed. EMS responded to evaluate. EMS notified Fire/Rescue to respond for assistance. PT began to complain of chest pain. Fire/Rescue and PT opted in for transport to emergency room.
Full body rash. High fever. Diarrhea. Pink eye. Red throat. Loss of appetite. Fatigue. Believed to be measles.
Chills; Fever; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 13Sep2021 at 10:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 14Sep2021 at 03:00, the patient experienced chills, fever and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fever and body aches were not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
24 hours later - Raised, red bumps on abdomen (no itch) 36-72 hours later - blotchy rash and red streak marks from the neck area down to the lower abdomen with itchiness... severe at nighttime.  Photos available
Client states she received her third and final Rabies PEP vaccine on June 21, 2012 after which she described the following events.  Client states she selected her left arm for administration of all three doses because she is a right handed person.  States following shot one and two of the series, she had general soreness, but with the third shot the soreness was increased.  States she felt the vaccine/medication enter her muscle during the administration phase, as well as feeling pain in her arm during administration, which was different from the previous two vaccines.  She explained that in the evening of June 21, her left arm became very painful with excruciating pain, along with the inability to lift it up or over her head.  By the next day, June 22, she states it was "bearable" but the pain remained and lasted through the weekend, she was able to lift the arm but had trouble with forward motion.  Denies any redness, warmth, or swelling.  By Saturday, July 21, her arm had begun to feel better, and she did light exercises that weekend; by Monday tripled her normal exercise routine, and quadrupled her stretching.  States her arm is beginning to feel better, but plans to give her doctor a call to discuss.
This spontaneous report was received from a medical assistant and refers to a 10 weeks old patient of unknown gender. No information about the patient's medical history and concurrent conditions was provided. On 09-NOV-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M044397 with an expiration date in 20-JUN-2018), orally, for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown), that underwent a temperature excursion from 9 degrees Celsius to 25 degrees Celsius during 20 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1801USA001571: US-009507513-1801USA001572: US-009507513-1801USA001565: US-009507513-1801USA001566: US-009507513-1801USA001567: US-009507513-1801USA001568: US-009507513-1801USA001569: US-009507513-1712USA003377.
Information has been received from a consumer concerning her 25 year old female friend with no pertinent medical history, drug reaction or allergies who on 08-FEB-2010 was vaccinated with GARDASIL (dose, route, and lot number not reported). Concomitant therapy included hormonal contraceptives (unspecified). On 09-FEB-2010, consumer reported that his girlfriend received 1 dose of GARDASIL and developed swelling of one finger on her right hand. He said that GARDASIL was not administered in her right arm, instead it was administered on the right side of her back. No diagnostic laboratories were performed. The patient had not recovered from swelling of one finger on her hand. The patient called the physician office. Additional information has been received.
The  Vaccination Site is a drive thru site.  People roll down the car window and are vaccinated. I am very short. The person who was injecting the vaccine was very tall. My shoulder is below the window so he injected me in the shoulder, not in the muscle of my arm. As that is what was more exposed. He should have had me stand up or he should have opened the door to inject me in the shoulder.  It really hurt, and took quite a lot longer for him to inject than my first vaccination. He had to push hard to inject it.  The stinging snd pain was very different than the quick first shot I received three weeks earlier and the stinging lasted an hour.  I was concerned the vaccine was injected in my shoulder and sent a picture to my doctor. He confirmed it was injected in the rotator cuff. This may cause problems as reported on the CDC website as a warning to vaccinators. What do I do???
A patient (sex and age unknown) received Tice BCG therapy with interferon and presented with enlarged tongue, sore back and low-grade fever.
pt recv vax; tongue went numb for approx 30 mins then returned to nl;3rd dose adm w/o incident;anti HBs neg;
Dose was given on day 31 of the vial being removed from the freezer to the fridge instead of day 30 or sooner. Per Moderna, the dose maintained the activity necessary to protect against COVID-19.
Inadvertently gave PEDIARIX at same visit as PENTACEL. Infant's mother aware - informed of possible increase local reaction per CPC, and to report any signs or symptoms. F/U msgs left on voice mail with no returned call.
11/19/22  I had blood in my urine and pain in my lower back. I went to the Emergency Room. They did a CT scan with contrast and found a mass on my kidney. On  11/23/22 I saw a Urologist. He felt it was more likely an unresolved infection from a previous incident I had in September. I was started on Nitrofurantoin.  I took the medication until I saw him again in December. He had me continue on the antibiotic and scheduled a CT.  I had a CT scan on 2/15/23 and it showed the infection was not gone. On 2/28/23 I was referred to the cancer center.  In March of this year, I went to the facility and saw a doctor who ordered biopsies of my left kidney and the lymph node that was swollen from the previous CT.  I had two biopsies on 4/14/23. The biopsies showed renal cell carcinoma in the lymph nodes. The kidney biopsy was clear. I am waiting to hear from the doctor.
Patient received 4 doses of the Moderna vaccine. Dates of administration include 2/8/21, 2/16, 2/25 and 3/9. She experienced a headache on 3/10 that resolved by her follow up visit 3/16/21 and was managed with tylenol only.
Case number PHEH2011US01456 is an initial spontaneous report received from a health care professional (medical assistant) on 11 Aug 2011. This report refers to a 19 year old male patient. He was vaccinated with MENVEO (batch number: A10047) intramuscularly on an unspecified date. He experienced a seizure after vaccination on 05 Aug 2011. The outcome was not reported.
Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 11:00 (Lot number: EN6205) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Muscle ache" (unspecified if ongoing); "Prostate" (unspecified if ongoing); "heart protection" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure abnormal (ongoing); SIMVASTATIN taken for blood cholesterol abnormal (ongoing); TAMSULOSIN taken for prostatitis (ongoing); FISH OIL taken for cardiac disorder (ongoing); GLUCOSAMINE HYDROCHLORIDE taken for myalgia (ongoing); AMLODIPINE. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "not recovered", described as "Headache". Therapeutic measures were taken as a result of headache. No follow-up attempts are possible. No further information is expected.  Additional information: Patient wanted to know if headache was normal. He was due to have the second shot on Tuesday which was in 4 days and he needed to find out if he needs to get it or not. He has taken 2 Aspirin every other night before he goes to sleep. He tries to take as little medication as possible. He has not had any testing as he has only had a headache for a week. The event did not require a visit to Emergency Roomor Physician Office. Patient had no prior vaccinations (within 4 weeks) and no AE(s) following prior vaccinations. He had no Family medical history relevant to the event.
Induration "welt" type reactions on both arms one from each pneumococcal 23 and influenza vaccines.
Redness, swelling, pain at injection site. High fever, elevated blood glucose, dehydration, nausea, fatigue. Saw MD, given IM and Oral antibiotics due to infection at injection site. Symptoms still present 7 days later.
Patient presented to outside ER c/o arm being swollen, red, painful after Pneumovax injection on 01/07/13. Area of swelling is 6cm. Patient also febrile to 102.9F evening of 01/08/13 and with slight fever on 01/09/13. Blood cultures drawn in ER, followed by administration of 2 IV antibiotics. Pt discharged to home on oral antibiotics.
Pt given DTaP in left deltoid on 6/18/03 24 hrs (6/19/03) pt returned with left upper arm rash measuring 17cm (length) x 10cm (width). Rash was erythematous, warm to touch. No evidence ? Treatment of Ibuprofen and compresses.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: The patient also received Other medication in 2weeks and patient had no known allergies. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills and body pain started evening of 30th with fever up to 102.5 and headaches. Body pain went away afterctwo days and only chills down to 89 (min.) deg. F and fevers up to 104 (max.)  for next 17 days. Average low temp 95 DEG. F, average high 103 deg. F. Minor fevers and chills followed for 5 more days.  Fevers always had headache. Dr. prescribed steroids and ZPak on 15th of April. Took Tylenol and ibuprofen alternate with naproxin.
DEMAND ISCHEMIA 11/8/2022 HYPOTENSION UNSPECIFIED  HYPOTENSION 11/1/2022 HYPOTENSION UNSPECIFIED  DEMAND ISCHEMIA 11/8/2022 TRAUMATIC HEMOPNEUMOTHORAX INITIAL ENCOUNTER  HYPOTENSION 11/1/2022 TRAUMATIC HEMOPNEUMOTHORAX INITIAL ENCOUNTER
Patient presented in employee bivalent COVID clinic. Pt may have received a dose of monovalent COVID vaccine during clinic. Unable to determine if patient received monovalent or bivalent vaccine.
Patient has head to toe itching, her right arm is swollen and red, restless sleep. Started overnight on 9/4/21 and has continued today 9/5/21
Patient had a flu shot on Nov 12, 2016. He stated that he has been having pain from the injection and is getting treatment for it. We filled his medications and counseled him on their proper use. He needed more information about the flu shot he got and we provided it for him also.
"Moderna COVID-19 Vaccine EUA" I felt extremely nauseous, had a migraine, heart pounding and tachycardic, fever, extreme body aches, dizziness, extreme tiredness, by 12:00 am through the next day.  At 3:00 pm on the second day I noticed I had a rash over my body. The rash itched, but my skin also felt sore to the touch.  The rash is raised, pink, and pinpoint.  I medicated with tylenol and ibuprofen.  The symptoms have decreased, but the rash is still there at 6:40 pm.
Lethargy, arthralgia (knees, shoulders)  Onset 22 hours post-dose, resolved by 36 hours post-dose
Red spot (L) arm x 1 day after vaccines administered. Dx w/cellulitis. Treatment cephalexin 500 mg cap. twice a day x 7 days.
covid vaccine breakthrough  dose 1 Moderna 2/25/21  025A21A dose 2 Moderna 3/25/21  0238A21A
Dose administered too soon. Second dose from different manufacture  Narrative: Second dose in COVID-19Vaccination series administered too soon. Patient did not have reaction as a result. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated. Sedond dose from a different manufacture and therefore the effectiveness is unclear/not been studied.
Fever, chills, sweating, muscle pain, fatigue, headache from 11pm on day of dose, 4/12/21, until morning of 4/14/21. Fever dissipated after roughly 12 hours, additional symptoms continued. By 4/14/21, feeling much better, though generally tired/light fatigue.
Incorrect age group--17 y.o. given Moderna.  Patient received second dose Moderna on 4/9/21.   No AE.
6 x 6 cm area of erythema and swelling around injection site that appeared the day after administrations.  There was a central  2x2cm area of vesicular rash.
8/8/21: Patient states he decided to go get tested for COVID19 due to being exposed to a co-worker that was feeling poorly.  He reports he had a positive COVID test on 07/30/2021 and states he was not really having symptoms at that time but eventually started having persistent diarrhea, occasional nausea and decreased appetite as well as having a nonproductive cough, that was exacerbated with deep breathing.  He reports he came to the ED due to not feeling any better.  Repeat COVID testing on 8/8/21 in ED was positive again and patient was admitted for further eval. He reports being fully vaccinated with Johnson & Johnson vaccine in May 2021.  8/9/21: Patient discharged home  He states he has been using over-the-counter Robitussin at home but has not been on any other prescription medications.  In the ED, patient had O2 saturations 91% on room air and was placed on 2 L nasal cannula.  Repeat COVID testing positive again.  He received a normal saline bolus, Decadron, and Zofran in the ED and reports feeling better.
MENQUADFI reached 1C and was then administered with no reported adverse event; Initial information was received on 24-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who reported that meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] reached 1c and was then administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect meningococcal a-c-y-w135 (t conj) vaccine (Solution for injection) (strength not reported, lot U7596AB, Expiry date : 14-Mar-2025) via unknown route in unknown administration site for Prophylactic vaccination (Immunization) and menquadfi reached 1c and was then administered with no reported adverse event (poor quality product administered) (latency: same day) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  Reportedly "Inquiry placed in proxy for final handling. Medical assistant requesting stability information regarding temperature excursion. Products: ACTHIB, PENTACEL, MENQUADFI and IPOL (all unopened). Reason: Occurred during recalibration of new thermometer. Max/low temperature reached: 33.8F minimum and 43.7F maximum. Duration out of labelled range: 47 minutes Human error? NO Does extended stability data cover the excursion? NO If negative advice, was the product administered to a patient? YES verified email address with caller. See associated case 01817531. Attempted to warm transfer caller, but none were available. Caller did not have patient information available at time of call. "  Action taken with meningococcal vaccine (Menquadfi) was not applicable.  At time of reporting, the outcome was Unknown for the event menquadfi reached 1c and was then administered with no reported adverse event.  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.