chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; Has an outbreak of shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included ZOSTERVAX (received about 6 years before reporting).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this case, he was member of public. The age at vaccination was not reported. The patient reported that he received both doses of Shingrix within the recommended 6 months' time frame, 6 years before reporting and wanted to know if he needed a booster dose. The patient was unable to provide the specific dates of the vaccines. The patient went to see his doctor last week from the day of reporting for other problems and when the doctor looked at his back, he stated that he was getting shingles/ outbreak of shingles. The reporter declined to provide healthcare professional information, he said he would provide the details if safety contact him.  The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years 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: "History of Thyroid cancer" (unspecified if ongoing), notes: Other medical history: History of Thyroid cancer. Concomitant medication(s) included: LEVOTHYROXINE, start date: 27Feb2015; ESCITALOPRAM, start date: 15Jun2017. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline", notes: Known allergies: Doxycycline & Erythromycin; Erythromycin, reaction(s): "Known allergies: Doxycycline & Erythromycin", notes: Known allergies: Doxycycline & Erythromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid from 06Feb2023 to 11Feb2023.  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.
Redness at injection site which persisted for 4 days; flu like symptoms on day after; diarrhea
Left arm pain on top of area where MMR was given subcutaneously on 08/13/04.  Egg sized knot felt.  Increased pain with palpation, entire arm aches and entire left side of body aches
pt recvd vax 3DEC92 10-1030AM about 7PM mom noticed a convuls jerking for about 5 mins; took another convuls about 1/2 hrs later; mom using APAP; some fever didn't check temp;
03/26/2019 PT RECEIVED THE PREVNAR 13 AT ABOUT 7:30PM. SHE STARTED TO FEEL PAIN WHEN SHE WAKE UP IN THE MIDDLE OF THE NIGHT AND THE PAIN CONTINUE UNTIL NOW. SHE STATED THAT SHE COULD NOT MOVE HER NECK WHEN SHE WAS WORKING ON 03/27/19 AND CALLED THE PHARMACY TO REPORT ON 03/28/19. PHARMACIST RECOMMENDED HER TO TAKE IBUPROFEN FOR PAIN AND MONITOR HER NECK AND PAIN. HER PAIN LEVEL IS GOING DOWN SLOWLY AND CONTINUE TO MONITOR.
The patient was previously well then shortly after the first COVID vaccine she began experiencing fatigue slowing to her swim times ( she is an high level swimmer) and felt "Off". She presented to my office on May 6, 2021 three days after her second COVID vaccine  I examined her and heard a slight hint of a wheeze and in addition to labs did a CXR which was Abnormal with evidence of a LLL consolidation and a pleural effusion.  We then did a CT scan with contrast and started her on antibiotics  and I called Pulmonology to get her in quickly since swimming trials were approaching and we had to do our best to get her in shape to compete.  We also did a rapid COVID test which was negative at my office on May 7, 2021-- The pediatric pulmonologist repeated the CXR 5 days later and there was more fluid and she was now having more sx of cough and feeling  worse so she was Admitted to the Hospital on May 11th and had a Chest tube placed and drained 950 cc of serous fluid .  Pulmonology, oncology and rheumatology consulted to rule out various other causes of the pleural fluid in an otherwise healthy girl.  Surgery  did the procedure and followed up outpt.   She was in the hospital for approximately 4 days.  Proximity of sx onset to doses  and other sources being essentially ruled out lead to concern for vaccine complication.
This is a pregnancy case. This 33-year-old female subject was enrolled in a study. The subject received Flu seasonal TIV (intramuscular) .5 ml on 22nd October 2014. On an unknown date, an unknown time after receiving Flu seasonal TIV the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown.
Patient described a very swollen hand on the same arm as injection.  Reported redness and a honeycomb like pattern.  The event slowly faded and no medical treatment was needed.
Rash consistent with chickenpox. Vesicles on  red base. Chest, upper extremities, lower extremities, on face. Evolved over 3 days.
Felt cold, and chilled after going to bed,  and feverish. took temperature and it was 101.8. couldn't sleep tossed and turned most of the night until I took Tylenol PM
Patient received a vaccine on 08-Apr-2022 which had got expired on 07-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 08-Apr-2022 which had got expired on 07-Apr-2022) in a 70-year-old male 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 (Patient received a vaccine on 08-Apr-2022 which had got expired on 07-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 08-Apr-2022 which had got expired on 07-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that total of 173 doses were administered having Lot number has 070H21A.  The dates of administration were 08-Apr-2022, 12-Apr-2022 and 13-Apr-2022 .  No information was reported on date of the storage of vaccine in refrigerator.  Vaccine was expired on 07-APR-2022.  The vial did not undergo any temperature excursions.  Treatment information was not reported.  HCP administer expired vaccine to patients, after the manufacture date of expiration and wanted an assessments on the case.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non-significant information-Additional Patient identifier were added.
This spontaneous report was received from a health care professional from state immunization official regarding an unspecified number of patients of an unknown ages and genders. The patients medical history or concurrent conditions were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose, route, lot number and expiration dates were not provided). Concomitant medication was not provided. No symptoms reported. This is one of two reports from the same source (MARRS #1504USA009652). Additional information has been requested.
Rt arm erythema with induration 5 x 6 cm. Pt has no fever. C/o tenderness in Rt arm.
About 1 hour after immunizatiion, pt states she felt her heart moving and her throat felt "scratchy"; by the end of the day she felt worse and noted her L upper arm to be swollen and warm with myalgia. No fever. Did not seek care until 11-3-14. Symptoms are better.
first dose/8 months ago.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 8 months ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with case US2021168360, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168360:Same reporter
Information has been received from an allergist physician concerning a child patient (also reported as "I believe it was a boy"), who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (Lot # not reported). The physician reported that the patient broke out in a rash after taking VARIVAX (Merck). The patient had been seen in touch with medical services. The physician thought it could be that the patient was allergic to one or some of the preservatives in the vaccine. The child got the vaccine at a pediatrician's office. The physician was not sure if they tested the patient for this, but the patient could be allergic to these preservatives gelatin and neomycin. The physician did not think the child had had another shot because of the reaction. No further information is available.
very painful arm starting in evening and into next day (12-24-21) after injection.  I took tylenol and salt bath which lessened the pain.  Left arm deltoid muscle slightly larger than the right arm deltoid. (I'm right-handed).  My left arm was very hard too much because of the pain  starting evening 12-23 through mid day 12-24.  Noticed redness in a triangle shape - point starting at injection site - when I showered 12-25-21.  Pain still present but not as severe as day before.  I put neosporin on site and will continue to monitor as this is Christmas day and not needing immediate emergent medical attention.
"I had an uncomfortable night and bad dreams,  left arm soreness more painful than flu soreness. 1/4/21 5am fever 100.5, and took Tylenol at 5am."  Reported feeling better now at 10:30 am
Headache, Arthralgia, ErythemaMultiform, UrticariaPruritus, L arm pain, fatigue, brain fog, knot under the skin, back pain Narrative:   Other Relevant History:
Temperature of 103.0 within 24 hours of Hep A came to office for evaluation 10/18/2006. Exam neg pt a febrile.
He started to he is like his eyes roll back and then he is like started to seizure a little it was minor like he kind of combo fainted; He started to he is like his eyes roll back and then he is like started to seizure a little it was minor like he kind of combo fainted; his BP was fluctuating and he was profusely sweating; his BP was fluctuating and he was profusely sweating; he started to get a little pale as soon as he got pale, he started sweating a lot; lost his consciousness; This is a spontaneous report from a contactable consumer. A 35-year-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Right on 05Jul2021 (around 17:35 ot 17:40) (Batch/Lot Number: EW0198) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient experienced his BP was fluctuating and he was profusely sweating. The pharmacy called an ambulance, they ran a few tests and he was hospitalized. After 5-10 minutes after getting vaccine he started to get a little pale as soon as he got pale he started sweating a lot. Patient started to have his eyes roll back and then he is like started to seizure a little it was minor like he kind of combo fainted. Patient was just moving a lot. Patient had a combo fainted  or seizure.Patient was aggressively moving he was just like moving his arm like back and forth and it was 30 or not even 10.Patient he was combo fainting a little after that he was profusely sweaty and it was like he lost his consciousness and another second he was like faint. He also his blood pressure was also fluctuating it was going up and it was going down. Patient was hospitalized on 05Jul2021. The hospital did a whole bunch of lab test and they all came back normal. Patient was discharged from hospital on 05Jul2021. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
The pt's mother reported that the pt experienced discomfort. There has been pain since the day of vaccination. It is not excruciating, however, it is constant and it started that day. It is very uncomfortable. The pt described it as localized to her shoulder. It hurts upon rotation. Unspecified medical attention was sought. It was reported that the pt is going to see an orthopedist.  Follow up information from a physician reported that the pain and aching in the right shoulder began on 5/18/99 and that the pt had "traveled to Guatemala one week after vaccination."  Additional information has been requested.
Headache, Myalgia, Fever,  Had swollen lympnodes, left axillary region, had chills and fatigue Narrative:
side effects after second dose/ How long do side effects last after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects after second dose/ How long do side effects last after second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects after second dose/ How long do side effects last after second dose). At the time of the report, VACCINATION COMPLICATION (side effects after second dose/ How long do side effects last after second dose) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Pt recv vax on 11/5/98; on 11/10/98 pt exp macular, itchy rash of shoulders, face & extremeties; fever; achey joints; hands & feet swollen; tx=Prednisone & Zyrtec
A few minutes after vaccination the pt had what appeared to be a seizure with momentary loss of consciousness.  Profuse sweating, tunnel vision and syncope also present. EMS was called and patient was transported to hospital directly from the pharmacy.
Administered by MA, Patient  tolerated okay, she complained of lightheadedness and feeling nauseated. Patient was given apple juice and then patient was laid down. RN came in to room and gave pt a cold compress evaluated her. Patient was diaphoretic and pale. Symptoms improved quickly. Patient drank more apple juice waited about 5 min and then color started to come back. Patient was able to sit up and stand for a few minutes. Denied being dizzy or lightheaded. Patient grandma took patient home.
RN administered vaccine, client stated she felt "wetness" on fingertips from holding up shirt.  Administering nurse unable to verify how much vaccine given.  Followed up with client on 3/2/2021, client states she is not having any arm pain or other expected side effects.  Client returned to  site 3/2/2021 so dose could be re-administered.
Starting around 4am, I was woken from sleep with severe pain in my left axillary lymph nodes. Separately, I took Aleve, used a heating pad, massaged the lymph nodes, and took a warm epsom salt bath.  None of these helped. At the time of my report the pain has not subsided, and I would still classify it as moderate to severe, sharp pain.  If pain persists I will visit the ER for pain relief.
Vomiting, diarrhea, loss of appetite, difficulty breathing. Admitted to Hospital Sept. 13 close to death. Doctors induced coma on ventilator, dialysis, pericardium drainage, right lung collapsed. Septic shock due to Metformin toxicity. Released Sept. 30 Back to hospital Dec. 9, 2019 with lungs filled with with fluid. Sent to Cancer Center with NSCLC with Alk mutation Stage 4 released Jan. 19, 2020. Never been sick before. Off Metformin and not getting second shingle dose
The pt developed fever of 101.8 deg. F.  and rose up to 105.8 deg. F. even on Tylenol. Went to ER and doctor stated it must have been a virus. Diagnosed with kidney infection. Bactrim ordered and given.
exposed to COVID19-positive daughter; This is a spontaneous report from a Pfizer-sponsored program. A contactable Nurse (patient) reported that a male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration in 31Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was scheduled to receive the second dose on 22Jan2021 but on 17Jan2021 his daughter had symptoms and tested positive for COVID-19. The patient was asking if he can take the second dose of vaccine after exposure to a positive person. The outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Redness and pain at site beginning evening after vaccine given and spreading to encompass anterior aspect of upper arm.
This spontaneous report has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # M009764/expiration date 23-FEB-2018, lot # M033212/expiration date 13-JUL-2018, dose and route were not reported) for prophylaxis, which was reconstituted with sterile diluent (lot # and expiration date were unknown). The vaccine was exposed to temperature excursion between 6 degrees Fahrenheit for 2.5 hours and 6.2 degrees Fahrenheit for 1 hour. There was no previous temperature excursion and the data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA003262: US-009507513-1708USA012210: US-009507513-1708USA012211: US-009507513-1708USA012212: US-009507513-1708USA012213.
First she started itching her arm were she got the shot the nurses there said she was fine then we started walking to my car she complained of a headache then she got dizzy then she lost control of her speech and all muscles in her neck some then she went pale as a ghost. 12/4/2009 MR for 11/7/2009 patient with c/o's headaches, neck pain, leg pain and dizziness.  Pediatric neuro consult ordered
Patient came to the pharmacy 2 days after receiving the vaccine, her arm was red, hot to the touch, and swollen. She did not have a fever, however states "she never gets a fever with infection."
Lymph nodes are swollen on the left side  It sore and tender on the left side
Menstrual period has consistently come earlier each month and duration is longer than before vaccine (used to be 3-4 days and now is consistently 5-6 days).
Chills; Fever; soreness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (soreness at the site of injection) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (soreness at the site of injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (soreness at the site of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Muscle Soreness in the arm the vaccine was given, has lasted from a few days after 2nd dose and continues today
Patient got very dizzy and disoriented and fell into bathtub.  Could not get out without assistance because he could not think straight.  This resolved after a few hours.  He felt very weak and ill for a week.
pt has very large local rxn; 8 inches in diameter;c/o itching @ site;DPH PRN;
Left deltoid was sore and painful then redden and swollen on 12/09/2010 in the morning. Patient applied cold compress at that time.
5 Patients administered expired doses > 12 hours post puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Patients administered expired doses > 12 hours post puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Patients administered expired doses > 12 hours post puncture). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (5 Patients administered expired doses > 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 16-Nov-2021, the vial was initially stored in the refrigerator. On 17-Nov-2021 at 8 AM, vial was first punctured and was stored In RT post puncture and did not undergo any temperature excursions.Total amount of time the vial was exposed to room temperature range 8° to 25°C, 46° to 77°F was 24 hours. No concomitant medications were reported. No treatment medications were reported.