chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from non- healthcare professional on 13 May 2016. This case involves a six-month-old female patient who was vaccinated with a third dose of PENTACEL (batch number C5137AA), third dose of PREVNAR 13 and a third dose of ROTATEQ (batch number, expiration date, and route of administration were not reported), in the left thigh on 10 May 2016. The patient illness at the time of vaccination was reported as yeast rash in diaper and also had received previously two doses of above mentioned vaccines (details not provided). Patient was allergic to amoxicillin and Ceftin. Concomitant medications were not reported. On 11 May 2016, one day (during the night) following the vaccination, the patient experienced seizure with generalized jerking of extremities, "the eye rolled back in her head". It was also reported that patient went limp and unresponsive for approximately 15 minutes. Patient required ER visit. Lab data included White blood cells test, Complete Blood Count test and Urine Analysis test. The patient corrective treatment was not reported. The outcomes of the events were reported as unknown. List of documents held by sender: none. Sender's Comments: This case refers to 7 months old female patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE, simultaneously with two other vaccines PNEUMOCOCCAL POLYSACCHARIDE VACCINE and ROTAVIRUS VACCINE. Next day (within less than 48 hours) patient experienced seizures with generalized jerking of extremities, eye rolled back in her head and she went limp and unresponsive for approximately 15 minutes. Patient had no history of seizures in the past, however patient had yeast diaper rash at the time of vaccination. In the absence of any alternative explanation and considering the positive temporal relationship, and although three vaccines were administered simultaneously the contributory role of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE cannot be ruled out.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified amount of patients of unknown age and gender. On an unknown dates the patients were vaccinated with doses of LIQUID PEDVAXHIB that underwent temperature excursions. On an unknown dates, unspecified amount of patients developed "localized reactions" at the injection site after receiving LIQUID PEDVAXHIB. The patients did not seek medical attention. No treatment was given for the events. The outcome of "localized reactions at the injection site was unknown. Relatedness between "localized reactions" at the injection site and LIQUID PEDVAXHIB was not reported. Thi sis one of several reports from the same source. Additional information has been requested.
October 2021 I received a blood transfusion due to low iron levels. Then in July 2022 I got my most recent transfusion.  Extremely low iron level which was extremely shocking since I had a transfusion just a few months ago. I went to my physician with the lab results and my doctor reran the iron numbers and my doctor had similar findings as to those from the lab. My iron serum levels were at a 26. I did have swollen lymph nodes occur after the vaccine itself. I had body aches and chills as well. The swelling in my lymph nodes as improved however has not gone away completely.
suspected vaccination failure; shingles; 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 details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Fatigue- lasted approximately 32 hours Headache- lasted approximately 24 hours  Arm pain- lasted approximately 36 hours  Nausea/ vomiting- one instance  Fever/ chills- ongoing as of 7:45pm 1/23/21, rotating ibuprofen and acetaminophen
Patient began to develop progressive weakness on the night he received his first vaccine dose.  This continued to progress over the course of two days  and included left sided numbness and left sided deficit, including facial droop. Patient presented to the emergency department and was admitted for an acute ischemic CVA.
started to hallucinate very badly; fell down the stairs; is not making any sense at all when she tries to talk; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (started to hallucinate very badly) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced HALLUCINATION (started to hallucinate very badly) (seriousness criterion medically significant), FALL (fell down the stairs) and DISORGANISED SPEECH (is not making any sense at all when she tries to talk). At the time of the report, HALLUCINATION (started to hallucinate very badly), FALL (fell down the stairs) and DISORGANISED SPEECH (is not making any sense at all when she tries to talk) outcome was unknown.            No concomitant medication provided. No treatment information provided. Action taken with mRNA-1273 in response to the drug was not applicable.  Company Comment: 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I woke up after a restless night after vaccination with chills, headache, joint and bone ache, muscles pain. Takin Advil and moving around helped a bit.
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a non-Healthcare Professional. This case involves a 20 months old male patient who was vaccinated with a 0.5 ml dose of IPOL (lot N020620 and Exp. Date 30-JAN-2019) via intramuscular route in the right thigh on 17-Sep-2018 that proper stability was not maintained. The patients medical history and concomitant medications were not reported. It was an actual medication error due product storage error and poor quality drug administered. It was reported that, IPOL (opened) with out of range from May to Aug 2018 with lowest temp of 8.06 C to 8.89 C for total time of 2 hours and 30 min. Then from April to Sept 2018 they had a low temp of 1.65 C for a total of 8 hours and 30 min. No information reported whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
The patient developed a macular rash on the face predominating around the cranium. The rash onset was within one minute after administration. The rash was erythematous at onset, it turned purple in color with time, and it decreased in intensity prior to the patient being discharged. The patient did not show any signs of anaphylaxis. There was no difficulty breathing. The rash did not spread to any other body part. The patient did not develop lethargy. The patient mantained stable vital signs.
10:45 vaccines given. 11am-3pm child fussy. 3:30-4pm child laid down for a nap. 4pm awoke in a pool of sweat and had an axillary temp of 104.6 = to 105.5 oral. Child was given 80 mg of children's Tylenol. Fever reduced to 101.6. Fever continued to range from a low of 101.2 to a high of 105.4, with the treatment of Tylenol 80mg q4 hrs, for a total of three days. The child's pediatrician was notified.
Pt has measles as small child, pt had MMR #1 in 1986, Pt required MMR #2 for college, given 11:15AM 9/2/04. Oral reaction (red, swollen, pain) at injection site immediately.
The patient reported on 11/11/21 they received Pneumovax 23 on 11/5/21 and on 11/6/21 experienced painful, red & hot to touch, swollen, itching left arm for 2 days
Pt was admitted on 7/30/21 for SARS-CoV-2 and remained hospitalized until 8/16/2021 when he expired.
Pt received flu shot approximately 1 pm 10/24/16 - seemed healthy. No adverse response reported. Pt found deceased in bed 10/25/16 am.
Information has been received from a physician and pharmacist concerning a female who on 28-DEC-2007 was vaccinated with a single dose of Zostavax (Oka/Merck).  Subsequently "the patient developed a shingles-like reaction."  The pharmacist stated that the patient had a tingling uncomfortable feeling in her upper back and also tiny red blotches in that area.  The pharmacist stated that the patient sought medical attention through a physician who stated that the patient "could have developed a mild case of shingles."  The outcome was unknown.  There was no product quality complaint.  Additional information has been requested.
Patient came to ED with complaints of worsening shortness of breath, nonproductive cough, sweats, and intermittent fevers and chills.  Patient was admitted to the hospital with Covid.
pt recv vax;exp itch,pain,swelling & inflammation at inject site;inflamed area as large as a silver dollar coin;this is one of 11 patients who exp the above rxn p/vax
Ischemic stroke. Presented to ER with confusion and altered mental status at Hospital. Transferred to another hospital for possible CVA
Systemic: High Blood pressue 168/135-Severe, Systemic: Hypertension-Severe
fly headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (fly headache) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (fly headache). At the time of the report, HEADACHE (fly headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-375497, MOD-2021-375498 (Patient Link).
Injected into left deltoid. contents of syringe sprayed onto her arm as I injected it. Likely a faulty syringe. Recommended by CDC to administer dose again.
General symptoms: fever, headaches, fatigue, nausea, vomiting, diarrhea, rash Narrative:
Swelling worsened. Patient has erythema in the right shoulder. Patient experience headaches, rash and arm is warm at the touch. Also noticeable readiness on the shoulder site when vaccine was given
I had fatigue, sore throat, chills and fever. I went to healthcare facility and got a positive Covid-19.  I did not take any medications.
Information has been received from a physician concerning a 15 year old female who was vaccinated with GARDASIL, 0.5 ml, intramuscular route. The physician reported that the patient developed painful menses after a vaccination with GARDASIL. The patient sought medical attention at physician's office. At the time of the report the patient had not recovered. Follow-up information has been received from the physician who reported that the patient with no drug allergies who in September 2007 received the first dose of GARDISIL. In September 2007, the patient developed right lower quardrant pain and heavy mense and had since started on oral contracptive pills with continued mild right lower quadrant pain. Laboratories test were performed. In December 2007, a whole blood hematocrit was 39.7, in April 2008 was 23.6 and was Willebrand factor antigen test was negative, and in June 2008 whole blood hematocrit was 39.3. At the time of reporting, the patient had not recovered. Additional information has been requested.
12/12/2022   I woke up during the middle of the night and was having a very real dream, I felt strange and began having a runny nose. I was a little incoherent and went back to sleep. The next morning when I woke up, I realized I had been dreaming or hallucinating.  I began having cold symptoms. I also had a fever. 12/13/22 I went to the doctor?s office and tested negative for Flu and COVID. I was given Tamiflu. My symptoms got worse. I was very tired for a few days. On 12/16/22  I took an at home COVID test which was positive.  I called the doctor and was prescribed Paxlovid.  I took the Paxlovid. I was never really sick, just a runny nose, a little bit of cough, fatigued and had a dream or was hallucinating. I was over it fairly soon. Then on  12/26/22, I woke up feeling bad and tested positive again for COVID.  I had a runny nose and a little bit of a temperature.  It took only a few days to get over it.
Administration of Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired vaccine) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products and treatment information were reported. It was reported that the vaccines were stored in freezer and one to two vials were taken out and placed in fridge each day as needed.
Allergic reaction six days after receiving vaccine...red blotch at vaccine site, itchy...this is second day and still the same. Have photo if needed.
I began with chills around 7 pm which I believe is normal. It wasn?t till 11 or 12 at night I woke up with a terrible migraine and I had heart palpitations / heart was racing which almost led me to the hospital.  Nothing helped the migraine and my heart started beating normal a couple minutes after the onset of symptoms.
Allergic Anaphylaxis . Epinephrine , Benadryl used to treat. Evaluation in ER and released in good condition 2 hours later
Left upper thigh swollen and red.  C/o itching after 48 hours of receiving shot.  Patient was put on Keflex 250mg.
PATIENT'S BLOOD SUGAR SKYROCKETED TO > 300, THEN PLUMMETED TO 23 ON FIRST VACCINE AND BELOW 20 ON SECOND VACCINE AND REQUIRED HOSPITALIZATION.
Pt had HPV vaccine 4pm yesterday. G-mom reports at dinner (6ish) pt c/o nausea and did not eat. Pt went to bed at midnight could not sleep started having headaches, dizziness and seeing flashes. Gmom set with pt until she fell asleep. Woke up today states she feels better "no nausea or dizziness just a small headache".
Information has been received from a Registered Nurse concerning a "20 some" year old female who was vaccinated with a first and second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on unspecified dates. After the second dose the patient did not seroconvert to mumps. The patient was not experiencing any symptoms. The patient subsequently was vaccinated with a third dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). No more information was available. There was no product quality complaint involved. Additional information has been requested.
My head has been spinning, I have been foggy, a little short of breath, heart ponding, etc for 6 days now. They have been consistent and are not getting better. I want to sleep and feel tired. Many people have noticed a difference in me.
Expired - 5 doses had been given at that point; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired - 5 doses had been given at that point) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022 at 7:40 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 21-Jan-2022 at 7:40 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired - 5 doses had been given at that point). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired - 5 doses had been given at that point) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 16-Dec-2021 Moderna vaccine was pulled from freezer. Beyond use date (BUD) of 15-Jan-2022 was printed in red and taped to the top of the boxes. The patient was notified of the error and patient denied adverse effects.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow up received. IRD changed (25-feb-2022 to 24-Feb-2022).
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (04Nov2022) Negative; (06Nov2022) Positive; (09Nov2022) Positive. Therapeutic measures were taken as a result of covid-19.  Additional information: The patient felt better and tested negative 2 days after ending Paxlovid treatment. Started having fever 4 days after ending treatment and tested positive on the 4th day. He was at the 7th day after treatment now, He had a 102-degree fever, headache, extreme nasal congestion, aches. It felt like he had the flu and testing positive for covid again.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
administered with liquid Adjuvant portion only; administered with liquid  Adjuvant portion only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number CL335, expiry date 23rd May 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The practice manager believed a patient might have been administered with liquid AS01B Adjuvant portion only of Shingrix as the practice now has an extra vial of lyophilized portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient details unknown at this time, however health care professional would be researching to track down the patient. She stated the event would have happened within the past couple of weeks, but exact date was unknown. The reporter consented to follow up. This case was linked with case US2021174385, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021174385:Same reporter
no adverse effect reported; a dose of GARDASIL 9 was inadvertently administered, that was expired; This spontaneous report was received from the office manager, referring to a patient of unknown age and gender. The patient's medical history, concurrent condition, previous drug allergies or reactions, and concomitant medication were not reported.  On 05-NOV-2019, the patient was inadvertently administered with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (route of administration, anatomical location and dose number were not reported, and lot number R024264 has been verified to be a valid lot number, expiration date reported and validated as 29-OCT-2019) as prophylaxis, that was expired (expired product administered). No adverse effect reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 08-AUG-2013 the patient was vaccinated with an expired dose of GARDASIL lot # 1511Z exp. date 26-APR-2013. Route was unspecified. No adverse effect reported. Additional information has been requested.
pt recv vax as a child;In 1989 following 1st pregnancy pt exp lack of response for rubella;in 1991 following 2nd pregnancy tested positive for rubella;1995 p/3rd pregnancy repeat eval was neg x 2, ELISA test confirmed no antibodies;
Left deltoid area became reddened with a lump to greater than a quarter size. The pt did not seek medical care even though possible side effects and available resources were reviewed with her at the time of injection.
Breast engorgement, heavy and  tender to the touch. Both breast. Feeling better today than this past week, but still sore.