chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchiness in area; 4-5 Bumps lighter red in left arm; Redish area below injection site/bumps which are a lighter red; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2022, the patient received Shingrix. On 8th August 2022, 3 days after receiving Shingrix, the patient experienced pruritus, papular rash and erythema. On an unknown date, the outcome of the pruritus, papular rash and erythema were not recovered/not resolved.   It was unknown if the reporter considered the pruritus, papular rash and erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comment: The case was reported by the patient. The patient received a Shingrix vaccine on Friday.  On the day of reporting, he noticed that his left arm had a reddish area of 3 inches by 2 inches below the injections site and within this area, there were 4 to 5 bumps which were a lighter red.  The reporter also stated that he had itchiness in this area.  The reporter consented to follow up. Patient gave consent to follow up with health care professional.
This spontaneous report as received from a pharmacist via a company representative refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 and an unspecified meningococcal vaccine for prophylaxis. On an unknown date, the patient experienced cellulitis at the injection site, the area was hot and painful, a fever, body aches and headaches. The patient visited an unspecified pediatric physician on an unspecified date and the physician did not prescribe any treatment for these problems. The outcome of events was not reported. Causality assessment was not provided.
Fever as high as 103.5 joints are extremely stiff and really red and hot in color
Within a couple of hours after receiving the vaccine, I developed a right facial tingling across my cheekbones my forehead and around my eye.  By the next day my entire right side of my face felt numb and I was drooling slightly.  You can see a slight droop on the right side of my mouth. Within a couple days I developed shooting pains across my face and into my eye causing tearing of my eye.  This lasted for 2 days straight and then it stopped.  A couple weeks later those same symptoms shooting pains across my face into my eyes started happening on the left side of my face and lasted for 1 day.  This has happened at least 6 times over the past year since getting the vaccine.  I have seen a neurologist and my primary care doctor who have now diagnosed me with Bell's palsy of the right side of my face and trigeminal neuralgia.  I am still waiting to have a new MRI.
Within 5 minutes of injection I began to feel lightheaded and dizzy. I had to sit in my vehicle for around 10 minutes before I felt safe driving home from work. I also experienced a metallic taste in my mouth. After sleeping from 9AM until 4:30 PM, I woke up with a reddened and swollen knot the size of a ping pong ball on my left bicep (where the injection was administered). The area is swollen and painful. I did not seek any treatment.
Case number PHEH2014US012470 is an initial spontaneous report received from a nurse on 18 Jun 2014. This report refers to a 14 year old female patient. Her past medical history and concomitant medications were not reported. The patient received only Men A lyophilized conjugate component of MENVEO (batch number: A14022), reconstituted with sterile diluent instead of Men-CYW 135 liquid component, intramuscularly on 16 Jun 2014. No adverse events were reported following this medication error (wrong solution used in drug reconstitution).
Patient reported itching/swelling of eyes and swelling of throat approx 5 minutes from administration of COVID 1st dose.  Rph called STAT.  Patient was alert, oriented; had no difficulty breathing/wheezing or SOB.  Blood pressure was taken and patient was normotensive.  Patient's symptoms did not worsen and she did not progress to anaphylaxis.  EMS arrived and assessed patient.  No epinephrine or further intervention was required.
Client had an itching sensation 10 to 15 after receiving the vaccine. Later that night a red raised rash appeared on her chest and back that lasted 24 hours.
Dose 1 in 2019, has not received dose 2; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  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 Twinrix, which led to incomplete vaccination schedule. No reactions were reported. The reporter asked how to proceed. The reporter did not consent to follow-up.
In January 2023 I had increasing congestion and my ears were getting clogged. I then developed a pounding headache. The morning of the 17th when I woke up, I thought my head was going to explode. I called my doctor. I took a home COVID-19 test, and it was positive. I took Paxlovid and I began to feel better after a few days later.
Information has been received from a physician concerning a 73 year old male with type 2 diabetes mellitus and hypertension who on 20-MAR-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot #658210/1079U). Concomitant therapy included sitagliptin phosphate (MSD), insulin, PRECOSE, BYSTOLIC, PRAVACHOL, ezetimibe (MSD), SYNTHROID and DETROL LA. Subsequently the patient experienced vaccine failure. The patient had no prior history of shingles when he received ZOSTAVAX (Oka/Merck). On 16-SEP-2008, after receiving ZOSTAVAX (Oka/Merck), he had an outbreak of shingles. The physician's notes state that he had LT to L2 distribution of shingles. The shingles began in the middle of the back and went around on the left side to the buttocks and down the buttocks to the left groin area. Then from the left groin area they went down the left leg to just above the knee. The patient had severe itching and experienced a slightly elevated temperature. On 18-SEP-2008, two days after the shingles first appeared, the patient had weakness in his legs and collapsed. He had to be admitted to the hospital for four days. The patient was recovering from the shingles and had some residual marks and scarring and sometimes experiences itching. Additional information has been requested.
Patient became ill 3 hours after dinner. Started to feel nauseous and then began vomiting shortly after. Symptoms lasted "about an hour." Patient felt fine the next morning.
"cut herself' on a broken syringe of GARDASIL 9/Finger flange broke, and a piece of glass got stuck inside the nurses finger; Broken syringe of Gardasil 9; "cut herself' on a broken syringe of GARDASIL 9/Finger flange broke, and a piece of glass got stuck inside the nurses finger; This spontaneous report as received from an office manager via a company representative, refers to a female patient of unknown age who was a nurse. The patient's medical history, concurrent conditions or concomitant medication were not reported.  On 03-JUN-2019, while the nurse was injecting the vaccine hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R023606, expiration date 06-MAY-2021, for prophylaxis (route, strength, and dosage information were not informed), the finger flange broke (half of the circle of finger), and a piece of glass got stuck in side the nurses finger and she "cut herself'. It was unknown if treatment was given or if laboratory diagnostics or studies were performed. It was also reported that the needle was able to be attached securely to the syringe and it tip cap attached properly prior to use.   The outcome of limb injury was reported as recovered on an unknown date in June 2019. The outcome of product quality issue was unknown. The causality assessment between limb injury and product quality issue and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Large induration, redness, tenderness, tingling, low grade fever, flu-like symptoms for x 2 days. Took 1 TYLENOL before shot.
Patient reported feeling nauseated and lightheaded a few minutes after administration, then became extremely pale and head went backwards. Moments later patient's face became red and body convulsed once.  Blood pressure and HR taken three times by nurse in the clinic.   2:15 pm 75/58 HR 94 2:20 pm 68/50 HR 88 2:40 pm  80/58 HR 88  Patient felt better and left 3:00 pm
After the vaccine I had body aches, fever, chills, no appetite, and extreme fatigue. I had these side effects for several days.
Left armpit swelling; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0151) via an unspecified route of administration in the left arm on 11Apr2021 at 12:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not have any allergies to medications, food or other products. Concomitant medication included etonogestrel (NEXPLANON) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 21Mar2021 at 12:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021, the patient experienced left armpit swelling that started 48 hours after vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event left armpit swelling was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Case number PHHY2013US109526 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT anti-rabies vaccine from 1997 to 2005. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with RABAVERT (batch number: not reported) intradermally on an unknown date. On an unspecified date the patient experienced injection site reaction (unspecified) following the erroneous intradermal administration. The event was reported as medically important. The outcome of the event was not reported. The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
VACCINE ADMINISTRATION ERROR. CLIENT WAS TO RECEIVE AN MMR AND A VARICELLA. NURSE INADVERENTLY ADMINISTERED A VARICELLA IN THE RIGHT ARM AND A PROQUAD (IWHEN IT SHOULD HAVE BEEN A MMR) IN THE LEFT ARM. THUS THE CLIENT HAS HAD TWO DOSES OF VARICELLA TODAY.  NO KNOWN ADVERSE AFFECT AT THIS TIME.
Patient was in recommended observation and was on the phone with her father and told him she began to feel nauseous. Shortly after she leaned forward from the chair and fell to the ground passed out. Her blood pressure was checked immediately and found to be 121/81. She was immediately responsive and said she still felt nauseous and light headed. EMT was called and they arrived within 10 minutes. Her father also arrived on scene. EMT determined that no serious medical treatment was required and patient left with her father to drive her home.
Patient received vaccine at 06:30. Patient relayed to Paramedic that she started to feel nauseous. Paramedic walked the Pt to the bed. The patient relayed to Paramedic that she believes the mask was causing the problem. The patient lowered her mask and informed Paramedic that she started to feel better. Paramedic obtained three sets of vitals. Paramedic contacted Dr. with no orders. The patient relayed that she no longer had any symptoms. Paramedic monitored the patient for an extra 10 minutes. The patient was informed to contact 911 if any problems occur after she leaves. Nausea. Obtained the patients vitals. Patient relayed she no longer had symptoms BP 108/76 HR 76 O2sat98% / BP 110/80 HR 78 O2sat 99% RR 16 / BP 112/82 HR 78 O2sat 99% RR 98% 16 2/12/2021 Reviewed by Dr.
Child was vaccinated within 1-2 minutes collapsed was lowered to ground by mom and nurse, had stiffening of right arm, clenching teeth, held breath, unresponsive lasted about 20-30 seconds, recover completely within 90 minutes.
pt recvd vax; pt exp'd hot feeling, chills,& diffuse itching;
patient received 2nd covid vaccine and passed away 24 hours later. He was on hospice because he chose not to treat his pneumonia. We are reporting this event as the death was so close to the administration of the vaccine
Patient stated that he has rash spreading on his body, stated that he took benadryl day after vaccine but rash hasn't gotten any better.
Age 17/ Given Moderna Covid vaccine/ Won't be 18 until 8/25/21/  No adverse reaction
11/20 - had pain down right side, then across chest and was coughing.  Called first nurse and was instructed to go to ER
Woke up with sore throat and head cold.  I had a lot of drainage which in two days turned into an upper respiratory infection.
This spontaneous report was received from a registered nurse concerning a female patient of unknown age. On 13-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, prior to the vaccination, the patient had seen the physician due to rash. The physician felt that it could be shingles. The patient was prescribed with acyclovir. The patient was told by the physician to check into the availability and price of ZOSTAVAX for the future but not suppose to get vaccinated. The patient misunderstood and went to a pharmacy who was offering ZOSTAVAX and was vaccinated before she started taking acyclovir. Reporter stated that the patient took acyclovir after the vaccination. Outcome of shingles was better since taking the acyclovir. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; No further AE; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 13-AUG-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R021636 was confirmed to be valid with expiration date 12-MAY-2021(exact dose, route of administration, anatomical location were not reported) for prophylaxis.  The temperature excursion was below 2 Celsius degrees (C) (1.1 C) for 27 hours and 45 minutes and above 9 C for 1 hour and 15 minutes (29 hours cumulative). The digital data logger was involved. No adverse effects were reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
The pt felt nauseated and chilled the day following the vaccines. The pt had 3 small red patches below the area where the vaccines were given and the arm was tender and sore and slightly swollen and itching. Symptoms resolved the next day.
had received one varicella vaccine as a child; This literature marketed information has been received from the authors in a published article title as stated below and refers to a 25-year-old female patient. The patient's concurrent conditions included systemic lupus erythematous (SLE). Concomitant medications were not reported. The patient denied history of chicken pox.   On an unspecified date, as a child, the patient received just on dose of varicella virus vaccine live (manufacturer unknown) (Lot #, expiration date, dose, frequency, anatomical location of vaccine, route of administration) for prophylaxis (Routine immunization schedule incomplete).      A copy of the published article is attached as further documentation of the patient's experience.
There were no signs or symptoms I compared his vaccine reports and they are missing info and extra vaccine was given.  Please call me regarding this matter.
Very sore arm 10 days post vaccination accompanied by sensitive teeth on left side of mouth and a stye on left eye. Recovery took 2-3 weeks
Approximately, 3:00 pm, 1/14/00, developed swelling & itching in hands, puffy face, tonge swollen, rash on abdomen & sick to stomach. Lasted approximately, 1 hr.
ACUTE ONSET OF MULTIPLE SEIZURES; This spontaneous report received from a consumer via a company representative concerned a 31 year old male of an unspecified race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2023 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAR-2023 (six weeks earlier), the patient experienced acute onset of multiple seizures that required intubation and ICU (Intensive Care Unit) admission, and was hospitalized (date unspecified). The patient was hospitalized six weeks earlier from that of reporting. The number of days of hospitalization was not reported and it was unsure if the patient was discharged from the hospital. The latency for acute onset of multiple seizures was reported as 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of acute onset of multiple seizures was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0-20230456890-Acute onset of multiple seizures- The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
nausea; flushing; This is a spontaneous report from a non-contactable Pharmacist.  A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 03Jun2021 (Batch/Lot Number: ew0151) age at vaccination of 22-years-old, as single dose (dose number unknown), for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient was not pregnant and was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea on 03Jun2021 and flushing on 03Jun2021. Therapeutic measure was taken as a result of the events and included administration of Zofran. IT was unknown if patient had Covid prior vaccination nor if she was Covid tested post vaccination. The patient recovered from the event on an unspecified date.  No follow-up attempts are possible. No further information is expected.
On day three after vaccine administration patient expired.  quite an active man, no signs led up to his death until maybe a half hour prior to the event.
After  having 3 of the moderna covid vaccines, I now have adverse health of   1.  elevated platelets   2.  heart murmur.   3.   abnormal CBC  4.  Heart palpitations  5.  Abnormal urinalysis
This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (Case number # 00658249). A contactable Female consumer reported that: Description: The primary reporter is the patient (Name) at (Phone number) (Full demographics not provided). The patient mentioned that she is experiencing headaches and her "muscles are tight" after receiving PREVNAR 13. The patient mentioned that the tightness transitions throughout the body. The patient stated she had two shots administered; the first shot on 21Sep2016 and a second shot on 28Oct2017. No PQC involved. No additional AE information provided. Product: Product: Prevnar Product Circular # Not Applicable Lot Number: Unknown by Reporter Expiration Date: Unknown by Reporter Dose/Frequency: Unknown by Reporter/See AE description Manufacturer (if available). The information listed above is all data we have received. Please do not contact Merck & Co., Inc. for additional information. Any follow-up information received by Merck & Co., Inc. regarding this case will be forwarded to you upon receipt. Please note that this information has not been reported to the FDA. Information regarding batch number has been requested.
at 11:37 patient mentioned thickening of her tongue, I  reseated the patient noted that she seemed clammy took bp 61/31 90 then administered 25mg liquid diphenhydramine .  otherwise seemed normal no dizziness , talking , texting her husband  11:43 bp 146/114 60 patient stated last feb her bp was 140/96 and that she was better. 11:45 bp was 152/114 60 still better,  12:01 bp was 133/100 56 she remained improved we monitored her until 12:09pm and advised she see her doctor, er or urgent care and that she discuss with md whether the 2nd dose would be prudent and if so have  the doctor or allergist administer
Right shoulder and upper back became bright red and hot to touch 15 minutes after injection of influenza vaccine.
Patient was given an expired Pfizer Covid 19  dose (expired 6/23 9:30pm).  Patient was informed and given another dose.