chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure/I have a mild case now. I've had both shingles vaccines; mild case. It is NOT fun; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 6-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient have had both shingles vaccine and had a mild case now. The patient stated that Valtrex was clearing them up. The patient stated that it was not fun, even in a mild case, get the shots. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Information has been received from a consumer concerning her 20 year old white daughter with a non remarkable past medical history and no allegies who in 1981 and 1997 was vaccinated with a first and second dose of MMRII, respectively. There was no concomitant medication.  The physician reported that the patient was seen in the office early in her pregnancy for obstetrical care and as part of the "standard of care" provided of all their pregnat patients, an early screening to determine the patient's Rubella Immunity Status was performed. On 03/14/01, laboratory results for rubella antibodies, IgG revealed a level of <5 (normal range 5 ->10), which indicated that the patient was non-immune to rubella. The patient did not receive the MMRII while she was pregnant. The physician noted that the plan was to give the patient a rubella vaccination. postpartum to restore her immunity. Additional information is not expected.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium
Sore arm for first two days, 100 degree fever for one day.   On day 8 after vaccine itchy and burning at injection site. Day 9 had to see my doctor.  Itching burning swelling.  Swollen to about the size of an apple.  Extreme pain and discomfort.
This spontaneous report was received from a health care professional refers to a patient of unknown age and gender. On 05-MAY-2015 the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # K008868; expiry: 19-DEC-2015) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. There was no product quality complaint involved. The outcome of incorrect product storage was unknown. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
left breast mastitis, prescribed cephalexin 500mg bid x 10 days. Started rx on 1/26/2021
My father begain feeling chills, anxiety on the evening of March 30th, 2021 following administration of the  Moderna vaccine earlier that day. The following day and throughout the week his symptoms continued to worsen including episodes of shortness of breath, anxiety, chills. My mother treated him with tylenol, cool wash cloth. His appetite was decreased but be was able to eat warm soup/broth.  My mother contacted his physician approximately 2 days after the episodes began  for an appointment but he could not be seen until the following week. On day 6 after the vaccine, April 5, 2021 he complained of significant shortness of breath and anxiety, The following day, April 6, 2021 my mother took him to a local free standing emergency facility  where they diagnosed  a possible MI. He was then transferred to the local hospital. There he was  admitted and diagnosed with heart failure and given fluids/medications. He remains hospitalized as of this submission.
Tingling and numbness in left hand and leg. Numbness mostly in my fingers and feet, but tingling in my knee, fingers, and feet. Occurs intermittently, usually when sitting, driving, or walking. Occasionally when walking or jogging.  Extremely painful headaches/throbbing in head, either in the middle of the night (causing me to wake up) or upon waking in the morning.. One headache happened during the day, but most were upon waking. The headaches started about 2 weeks after vaccination, were happening daily for about a week, and have sense become more intermittent, happening only once or twice a week.
Tested positive for covid; Tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6200), on 23Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 01Dec2021 as dose 3 (boster), single (Lot number: FA6780) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "not recovered" and all described as "Tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Positive, notes: tested positive for Covid.  Clinical course: Caller states that he tested positive for covid, he went to [Place withheld] on the 14th and came back Monday he started feeling itchy in his throat and Wednesday he took a test, the [Name withheld] laboratory covid at home test and it was positive. His wife and him fully vaccinated, both tested positive. His wife tested positive yesterday. Caller inadvertently remotely disconnected the phone line. Outbound Call was made. His Wife was vaccinated and tested positive, she got her vaccines on all the same dates. Wifes covid vaccines were also all from Pfizer.  No follow-up attempts are possible. No further information is expected.
Patient did not report any problems at the time of administration.  45 minutes after administration the patient notified us that she experienced pain at the injection site which started 5-10 minutes after the vaccine was administered.  The patient stated started as numbness and tingling in arm which traveled from the administration site down to the tips of fingers.  Stated 5-10 minutes after adminsitration and worsened over the 45 minutes.  Observed the patient for 15 additional minutes and symptoms had not changed.  She also stated that she was feeling hot and diaphoretic.  Advised to take ibuprofen.  Patient took 400mg ibuprofen. 1 hour later (2 hours after administration) patient stated localized numbness resolved but still with pain in elbow and tingling fingertips.  Also stating pain in shoulder blade area.
24 hours after vaccine woke up with significant body aches. Then rash started on left forearm and  wrist. Following day it spread to right arm and back.
redness and warmth at injection site after shots given on 05/05/2008. Seen in ER and treated with antibiotics for cellutitis per parent by phone call 05/08/2008 1:30 pm.
11/22/2021: Pt was admitted to the hospital due to acute respiratory failure with hypoxia due to covid. Pt has had a cough since last week and getting worse. Self reported a fever of 101F over the weekend. PO intake has decreased. Chest x-ray shows multifocal pneumonia. Wean off of O2 as tolerated. Decadron 6 mg for 10 days. Start zinc, vitamin D, and melatonin. Start albuterol, pulmicort, and incentive spirometer. Started on rocephin  11/23: Procalcitonin was negative, discontinue rocephin.  11/24-25: continue therapy. 11/26: Pt was discharged. continue steroid for a total of 10 days and symptomatic treatments
A report has been received from a Health Professional concerning a 17 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT (INTRANASAL) started on 21-Jan-2014. Office manager reported that on 21-Jan-2014, they inadvertently gave expired FLUMIST QUADRIVALENT to two patients. Not reporting any symptoms. The outcome of the event of INADVERTENTLY ADMINISTERED EXPIRED FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by reporter.
Numbness tingling started in left forearm then left foot progressed into left leg and eventually into right arm and legs and both feet. Prickly sensations, blurred vision, dizziness.
Information has been received from a Nurse Practitioner concerning a male patient who on 03-SEP-2010 was inadvertently vaccinated SQ with a single dose of ZOSTAVAX (Merck) (Lot# unknown). The nurse reported that the patient was intended to receive VARIVAX (Merck). No adverse symptoms were reported. No further information is available.
body aches after 4 hrs, fever of 102 the evening after the shot that lasted about 14 hrs, Now he has nausea, headache, vomiting, body aches. He was COVID-19 positive back in October.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 20-AUG-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress: manufacturercity: manufacturerstate: manufacturercountry:; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Pt was given Covid-19 Monovalent for 12yrs and up and not the Covid-19 Bivalent for 12yrs and up. Pt was monitored for 15 minutes after vaccine and no reaction noted.
just a little swelling and tenderness at the injection site; tenderness at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Jul2021 10:30 (Lot number: SA6780) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (ongoing), notes: had for many years. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset Jul2021, outcome "recovered" (Jul2021), described as "just a little swelling and tenderness at the injection site"; VACCINATION SITE PAIN (non-serious) with onset Jul2021, outcome "recovered" (Jul2021), described as "tenderness at the injection site". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site pain.  Additional information: History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Patient did not require a visit to emergency room and physician office. No prior vaccinations (within 4 weeks). AE(s) following prior vaccinations was none. No relevant tests. No other Products. Patient's Medical History (including any illness at time of vaccination) was hypertension. Additional information for other conditions included had for many years. No investigation assessment. After the first dose she had no problem, just a little swelling and tenderness at the injection site that lasted about day and a half. She has done no treatments. A just a little swelling and tenderness at the injection site additional Vaccines Administered on Same Date of the Pfizer Suspect was none.  No follow-up attempts are possible. No further information is expected.
Patient signed up online to receive the Moderna vaccine. She completed her DOB on the form, however the assessor AND the administrator did not notice that her 18th birthday was not until June 13th. The vaccine was given, even though it is supposed to be only for 18 years and older.  Today, April 27th, I received a call from public health and was informed of the administration error. I reached out to patients mother to inform her of the administration error. The mother reported that the patient had no complications, and still plans to send her to receive her second dose at the designated time.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID19 INFECTION; This spontaneous report received from a patient concerned a 61 year old female of unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid issues and was taking thyroid medications, occasional alcohol user, and occasional smoker. The patient had drug allergy to Codeine, Cepacol, Flagyl. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 23-AUG-2021) dose was not reported, 1 total administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-DEC-2021 the patient had symptoms from morning. The symptoms were not severe. The patient had headache, chills, low grade fever and fatigue (suspected covid-19 infection, suspected clinical vaccination failure) (Dose number in series 1). The patient still had fatigue at the time of reporting but other symptoms had resolved (dose number in series 1). The patient had rapid Covid-19 antigen test and results came back positive on 26-DEC-2021. The patient had self treated herself at home. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with a product quality complaint, and reference number requested.; Sender's Comments: V0- 20211266733-Covid-19 vaccine ad26.CoV-2.s- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
I completed my series of the GARADASIL vaccines last month. I have no idea if I am having a side effect from the vaccine but over the last 3 weeks I have been having the occasional dizzy spells. I have never had an actual syncopal episode, just the near syncopal episodes. I am an ER nurse and am familiar with the fact that many people try to relate medical problems to sides effects of their medications. I know that many people have reported unusual symptoms after receiving GARDASIL so I thought I would mention my near syncopal episodes although they may not be related. I have never had any serious medical or health problems though. I did have a thorough lab work up back in January after I turned 30, and my lab work was perfect. I have not had any labs tests done since then.
Fever (102.8), elevated resting heart rate (97-108 while lying down), aching joints, weakness, confusion, sleepiness, mild headache, nausea, loss of appetite.
For several days I had racing heart beat and my head felt like it was being reconstructed--not pain, but could feel the reconstruction, but it wasn't until about 3 days later I noticed my tongue was foamy. I didn't realize how disoriented I was until someone mentioned that 5 days later.  I did attempt to sleep a lot to let the crazy pass over me.  I'm now a week later, with only noticing slight head adjustments going on in there, but I was able to work through most of this, although the racing heart beat was the most scary and the head thing was distrubing.
H1N1 vaccine administered by nurse at school.  Within several minutes of receiving shot student c/o of vomiting.  Temperature 98.4, Pulse 82, Blood pressure 120/78.  School nurse monitored child in office for 30 minutes.  Notified parent and child returned to class with no complaints.  About 11:30 am  Blood pressure 118/78, Pulse 82, Temperature 98.2 and respirations 16.  No complaints from student.
After the administration she felt tightness in her fingers in the same arm as the injection. It left a few minutes after the injection.
Information has been received from a registered nurse concerning a 21 year old female with syncope, anxiety and no known allergies reported. On 9/11/06, the pt was vaccinated IM with the first dose of HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653650/0702F). Concomitant therapy included Lexapro, Wellbutrin, Klonopin, Nicomide, and Zithromax. On 9/12/06 when the pt woke up, she complained of her pupils being dilated, a headache, light headed and reported that she feels like something in not quite right. It was reported that it was unknown if the pt had eaten that day. The pt sought unspecified medical attention. At the time of this report, the pt had not recovered from the events. Additional information has been requested.
After about three hours I began to feel a little down ... like I was going to have the flu. At the six hour point I began to feel like I had a fever, slight shivering. By the 12 hour point I was shivering quite a bit. At the 15 hour point I was shivering uncontrollably, as if I had a serious fever.  It lasted until about the  21 hour point ... then I began to recover. AT the 24 hour point I was 90 percent recoveredd, and 100% at the 28 hour point. Also had a pretty sore arm at the shot site.
2/6/17 pm: patient felt sore at injection site and tired 2/7/17 all day: progressively sore, patient had chills and fatigue. He could not move his arm. He iced the inflamed injection site, took ZYRTEC 10mg and Naproxen at bedtime. 2/8/17 am: called nurse. His entire arm down to his elbow, shoulder, pecteralis and auxilla area red and swollen. Took more Naproxen. 2/9/17 redness better, more movement still sore 2/10/17 no redness, no soreness. On Monday, February 6th, 2017 patient received PNEUMOVAX 23 in the left deltoid administered by RPh. The patient called his daughter who is a Pharmacist. He was complaining that last night his arm was getting progressively more sore and painful. He took a ZYRTEC 10 mg that evening and Naproxen EC 500mg at home. When he woke up on the morning of Wednesday, February 8th, 2017 his injection sight, his arm down to his elbow, shoulder, and pectoralis area was red and inflamed. I asked if he was having itching, difficulty breathing, or chest pain. He replied that he didn't have any of these symptoms. I told him to switch to BENADRYL for an antihistamine and take 1 capsule up to 3 times per day. Also, I told him to ice the area and take his Naproxen EC 500 mg with breakfast. I encouraged him to show Dr. his arm at his regular office visit the exact same day. Dr. did a physical evaluation and thought he didn't need any further antihistamines and thought the reaction was localized. Patient didn't take any BENADRYL that day but he did ice the area during the morning. His aches and pains went away and he didn't have any more chills. By the evening, he was progressively better. Today, Thursday February 9th, 2017, patient woke up and the area is not as red or swollen. His axillary region is sensitive to touch and tender. He has increased range of motion in his left arm. He continues to improve and will take a Naproxen EC 500 mg tablet with breakfast. We will continue to monitor the patient by calling him each day. If at any time he needs to be seen by a physician, we will consult you for an appointment or send him to the ER if needed.
The patient was administered the Moderna vaccine before the age of 18, which is off-label use according to the. She was told to vaccinate by her PCP due to multiple chronic conditions and had a doctor's note, but it should not have been administered at age 17.   The patient and her parent reported no adverse reactions to the actual vaccination. The VAERS report is being filed because it was an administration error for dose #1.
RSV vaccine made my husband very sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: RSV vaccine made my husband very sick).  The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to RSV vaccine.     It was unknown if the company considered the sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 27-AUG-2023 This case was reported by a consumer via interactive digital media. RSV vaccine made my husband very sick. Follow-up would not possible as no contact details were available.