chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician and refers to a 17-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date approximately in January 2016 (reported as "a year ago") and on 13-JAN-2017, the patient was vaccinated respectively with the first and second dose of GARDASIL injection (lot # of second dose of vaccine M014929 with expiry date of 27-MAY-2016, dose and route of administration were not reported). There were no adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Vaccine given at 33 days after refrigerated. Use by date 9/25/21
This spontaneous report as received from a registered nurse refers to a 61 year old patient of unknown gender. On 12-NOV-2014 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (dose, route were not reported, lot # K003597, expiration date 12-MAR-2015). No adverse effects were noted. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient Statement:  No symptoms until the following morning at about 7:30am when I noticed mild discomfort and subsequently measured my heart rate via iWatch.  The results indicated tachycarida, with rates raning from about 54 to 173 BPM,  The rate would rise slowly to different peaks, remaining at that level for 1 to 3 mins, then return slowly to normal, the periods of change being in the 1 to 3 minute range.  When running a ECG via my iWatch the Sinus Rhythm appeared abnormal only in period, showing changing rates mirroring what my BPM showed.  The distress was more psychological than physiological, feeling about the same as when our grade school PE teacher would make us run every day.  I hated running, as the breathing burned my lungs and gave me discomfort, but I'm sure it was the same for all of us.  I have no allergies, have never had Influenza, was never absent a single day from school for sickness from Kindergarten all the way through 4 years of college.  I had a cardio work-up a few years ago that showed nothing abnormal, and a health screening about 2 years ago for deep vein and extremity circulation without nominal results.  I've been nearly vegan for several years, and have lost around 30 lbs within the last year, approaching a BMI withing normal range.  I do have a slightly elevated BP, but that is reducing with weight loss.  I have had kidney stones since about 1996, but they tend to pass withing a few hours.  Nothing else to report.
Vaccine administered beyond Expiration date. However, per Moderna- all vaccines met viability requirements.  Completing VAERS as directed.
allergic to the newer vaccine for bacterial pneumonia; This is a spontaneous report from a contactable consumer (patient). A currently 66-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (manufacturer unknown), via an unspecified route of administration on an unspecified date at single dose for bacterial pneumonia, immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergic to the newer vaccine for bacterial pneumonia on an unspecified date with outcome of unknown.    Pfizer is a marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
given after manufacturer expiration date of 09/30, but manufacturer stability data supports stability of product through 10/19/22
received 3 doses on 25-MAY-2022; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 51-year-old female patient who received HBV (Engerix B adult) (batch number tb3kn, expiry date 3rd December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B adult) (batch number tb3kn, expiry date unknown) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B adult) (batch number tb3kn, expiry date 3rd December 2023) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th May 2022, the patient received Engerix B adult (intramuscular) .5 ml, Engerix B Pre-Filled Syringe Device, Engerix B adult (intramuscular) .5 ml, Engerix B Pre-Filled Syringe Device, Engerix B adult (intramuscular) .5 ml and Engerix B Pre-Filled Syringe Device. On 25th May 2022, unknown after receiving Engerix B adult, Engerix B Pre-Filled Syringe Device, Engerix B adult, Engerix B Pre-Filled Syringe Device, Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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 Information: GSK receipt date: 27 May 2022 Reporter's comment: The reporter was an administrator for a clinic who reported that a patient received 3 doses of Engerix B on same day. The  reporter consented to follow up. Additional Supportive Information: The patient received 3 doses of Engerix B on same day which led to overdose.
Information has been received from a nurse practitioner concerning a 20 year old female who was vaccinated with a dose of Gardasil.  Subsequently, the patient developed a fever of 102-103 that was unable to be broken.  The patient also had a stuffy nose.  The fever lasted 3-5 days.  At the time of the report the patient's outcome of stuffy nose was unknown.  Additional information has been requested.
Mother called 3-22-10 @ 11:35AM to report she took child to ER on 3-21-10. Mother reports child woke 3-21-10 with increase redness and pain to L arm. Area of redness "the size of a golf ball." Patient was Rx antibiotic for "skin infection". Denies fever.
POCT Covid 19 Antigen test  positive; POCT Covid 19 Antigen test positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Jan2021 12:00 (Lot number: EN5318) at the age of 49 years as dose 2, single and administered in arm left, administration date 11Jan2021 12:00 (Lot number: EL3246) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies:Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jan2022, outcome "unknown" and all described as "POCT Covid 19 Antigen test  positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive, notes: Nasal Swab; vitamin b12 decreased: (Jul2021) low.  Clinical course:No other vaccine in four weeks  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and suspect drug BNT162B2 cannot be excluded.
high fever screaming fits staring into space; a few moments happened on 7JUN93; tmp on 11JUn93 t100.3 (ears) rash @7-11 days; neurologic nl;
PATIENT NOTICED SWELLING AT THE INJECTION SITE ABOUT 8 HOURS AFTER ADMINISTRATION. SWELLING INCREASED NEXT MORNING. PATIENT SEEN IN ER, TREATED FOR CELLULITIS NO FEVER NOTED.
Nearly 25 days after receiving my 1st Moderna vaccine I woke up on Easter morning with a very stiff Right wrist.  By 1pm that day I was experiencing a lot of swelling and found it difficult to prepare food for a picnic we were going to. By 4pm that day I had to wrap my hand in ice, thinking it would provide some relief and took 2 Tylenol. By about 6:30 my husband and son were taking me to ER and on the way my Left hand began to swell and experience similar pain. By the time we arrived at the ER I was in excruciating pain in my entire hand up to my elbow and it felt like fire was burning through a vein up my arm. I had no use of my fingers which had stiffened and appeared maimed.  After blood work, assessment, pain medication and steroid injection I was released with no real answers. other than to see my physician for follow-up.  I was given a 12 RX for steroids which helped after the 4th day.  I saw Dr. today, as she had been on vacation all last week.  We discussed the possibility of an adverse reaction to the Moderna vaccine, and she recommended that I submit my information to you.  4/15/2021
First time looking at my arm since the two vaccine shots and noticed regular bruising at the injection site, but a large red patch below the injection site on my bicep. It looks like a sunburn. It is a bit sensitive to touch (feels like touching a bruise). The red area is about the size of a  softball.
injection site soreness; if he squeezed something it would hurt in his wrist; This is a spontaneous report from a contactable pharmacist.  A 73-years-old male patient started to receive bnt162b2 (Pfizer-BIONTECH Covid-19 Vaccine,), intramuscular on 23Jan2021 (at the age of 73) as a single dose for COVID-19 vaccination. Medical history was not reported.  There were no concomitant medications.  The patient previously took TYLENOL.  On 26Jan2021, the patient reported that he experienced  mild side effects included injection site soreness that lasted for one day and in one of his joints, it wasn't any soreness, but in his wrist, if he squeezed something it would hurt. Both of these symptoms lasted one day. The pain was mild.. He clarifies the soreness lasted for 2 days, Sunday and Monday, and was gone by yesterday. The clinical outcome of the events was recovered, the outcome of the event of took TYLENOL was unknown.  Information about batch lot number has been requested  Amendment: This follow-up is being submitted to amend previously reported information: event was deleted.
See accompanying form with course of events following Pneumovax injection.  In addition, patient reports 12/17/07 a spot on her back, not painful, looked like an insect bite, difficulty sleeping.  Later that day, c/o extreme pain under R shoulder blade which later spread to under R breast.  She had MRI scheduled with physician appointment.  On 12/18/07, seen by Dr. who diagnosed shingles, prescribed Valtrex.  Valtrex helped to improve sx.  She says that she has since recovered to about 90% with those sx.  She reports having a mild-moderate case of chickenpox as a child, approximately 8-9 yrs. of age.  She says that 4 other family members had chickenpox at same time.  She denies ever having shingles before.
Started menstrual cycle day after Vaccination when it wasn't due.  Same thing happened on the first dose of Moderna. Menstruation has not resumed to this date.
On 02/08/01, this patient had a reaction 20-30 cm edematous and erythematous, warm area right upper arm. Prescribed warm compresses and steroids.
Information has been received from an office manager concerning a 16 year old female who on 04 Dec 2006 was vaccinated IM, into the left deltoid, with 0.5 ml second dose of Gardasil (lot #653736/0868F). On 05 Dec 2006 the patient developed an itchy rash on her arm. The patient was treated with Benadryl and the rash was gone the on the night of 05 Dec 2006. On 06 Dec 2006, the patient recovered. The office manger reported that there was no adverse reaction after the patient's first dose of Gardasil. Additional information has been requested.
post 8 hours - sore arm, post 9 hours - sore back, hard to take a deep breath, foggy head feeling,  post 10 hours - sore legs and overall body aches
Chills,  body ache, nausea,  mild fever, joint pain,  fatigue, and migraine like headache.
sore arm/ hurts; Not feeling good; large red area/ still very red; difficult time sleeping; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Influenza vaccine (received on an unknown date).   On 23rd September 2021, the patient received the 1st dose of Shingles vaccine. In September 2021, less than a day after receiving Shingles vaccine, the patient experienced pain in arm, feeling bad, localized erythema and difficulty sleeping. On an unknown date, the outcome of the pain in arm, localized erythema and difficulty sleeping were not recovered/not resolved and the outcome of the feeling bad was recovering/resolving.   It was unknown if the reporter considered the pain in arm, feeling bad, localized erythema and difficulty sleeping to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported the case. The age at vaccination was not reported. The patient got shingles vaccine in right arm , the day before reporting date. The patient had gotten the flu shot on that side also and stated that never was given chance to get the shingles vaccine on right arm. The patient's arm hurt really bad and there was a large red area, hope the redness and pain go away. The patient reported some side effects like not feeling good and very sore arm and was better in the morning of reporting date. The patient had a difficult time sleeping because he/she sleep 90 percent of the time on left side The patient agreed that the vaccine hurts after several days and had still very red than getting shingles. The follow-up would not possible as contact information was not available. The patient would go back in a few months for second one.
Narrative:  COVID infection following COVID vaccine series 01/05, Pfizer, dose #1 02/09, Pfizer, dose #2 05/26 CXR impression: Streaky peribronchial opacities emanating from both hila may 07/29 pt cc: chills, cough, fatigue, fever, headache, loss of taste, nausea, rhinorrhea, dyspnea, sore throat exposure: +COVID clinically resolved 08/06 COVID swab, result: detected 08/12 SARS-COV-2 LINEAGE result: B.1.617.2 08/12 SARS-COV-2 clade result: 21A Delta
[Pfizer Biotech vaccine] use for COVID-19 under Emergency Use Authorization (EUA): Developed Zoster 5 months after receiving the vaccine.
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. There was no information on patients pertinent medical history and drug reactions or allergies. The healthcare worker reported that an unspecified number of patients received unspecified doses of improperly stored RECOMBIVAX HB, product lot# K006262, expiry date: 17-DEC-2015. No adverse effects were reported. There was no product quality complaint involved. The outcome of the events were unknown. This is one of the several reports from the same source. Additional information has been requested.
Lingering redness side effect.; This case was reported by a consumer via interactive digital media and described the occurrence of erythema 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 erythema. On an unknown date, the outcome of the erythema was unknown.   It was unknown if the reporter considered the erythema to be related to Shingles vaccine.     Additional Information: GSK receipt date: 18-OCT-2022 Reporters comment: This case was reported via interactive digital media. The patient had lingering redness as side effect. Additional Supportive Information: The follow up would not possible as no contact details were available.
Fever started about 24 hours from vaccination time.  Was around 104 F.  Cough started around 48 hours after.  Loss of appetite and extreme fatigue.    Illness progressed until 5/28.  On 5/28 she expirenced very labored breathing and was taken to the ER.  Oxygen level was only 86% and she was admitted to the hospital.  She could not keep her oxygen levels up and was oxygen for 4 days.  She now has to take breathing treatments twice day for "asthma".
Patient called the pharmacy on 3/29/23 stating she has a rash on her right flank area that is red and itchy that she can't explain otherwise. She wanted to make sure the Shingrix did not contain live vaccine as she just had her Shingrix dose 2 days ago on 3/27/23.  She said she started using Hydrocortisone cream OTC which helps a little. I also advised her to use Benadryl orally.
DIED; This spontaneous report received from a consumer via social media concerned a female of unspecified age, race and ethnicity. 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, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died. It was reported as "my wife died from the vaccine" On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221155633- Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Left arm red, rash, swollen, itchy, painful. The redness has spread over the past 3 days, still hot to the touch, raised red rash, itchy.
Client is 12 years old and was given a pediatric dose of the Pfizer Covid-19 vaccine. It does not need to be repeated and client will receive age appropriate dose for dose #2.
Developed shingles approx 10 days after first dose of Moderna vaccine.  Visit with dr, given prescription for prolonged prednisone taper, acyclovir, and Tylenol 3. Rash cleared up around 8/21/2021
This spontaneous report was initially received on 29-SEP-2015. The case report was received from a(n) Health Professional and concerns a(n) patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medications and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 29-SEP-2015 - unknown stop date, batch no: not provided. Route of administration: not provided. Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 29-SEP-2015, after starting / treatment with AFLURIA the patient experienced Received AFLURIA via breastfeeding (non serious, outcome: Recovered / Resolved). Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. The relevant test results see appropriate report section, please add other relevant test results manually as appropriated. Reporter's assessment: None
Sinus problems, no taste or smell. Tested positive for covid after receiving vaccination. Severe headaches, pain in the upper abdominal area, back of the legs and to the kidneys. Was provided muscle relaxers by healthcare provider.
Since the vaccine my left arm is very weak, due to numbness, my joints is very stiff since 10/16/2014. The pain started after the vaccine was administered.
Itching all over, while being evaluated by EMS, patient began seizing-transported to nearest ER.
About five minutes after vaccination she began to feel very weak and dizzy.  No shortness of breath or wheezing.  No hypotension.
ACUTE RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Initial information received on 22-Jan-2019 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a seven months old female patient who received a 0.5 ml expired dose of ACT-HIB batch number: UI860AAA, expiration date: 09-Jan-2019 via unknown route in the left thigh on 22-Jan-2019. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was PREVNAR 13, FLULAVAL and PEDIARIX. It was an actual medication error due to expired vaccine used. A 7 month old received expired ACT-HIB vaccine. It was unknown whether patient experienced any adverse event following vaccination. 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.
Approximately 24 hours after the Moderna injection I developed low grade fever, chills and fatigue. However, the adverse reaction was severe heart pain. First episode lasted about 3-4 minutes. then, a second episode of heart pain lasting 2-3 minutes. As I said, the pain was severe and felt like the entire heart muscle was involved. I live alone and one the heart pain subsided, I took tylenol and went to bed.
Shingles, pain, swollen axial lymph nodes on side of the shingles rash.
Lymph node in right arm pit extremely swollen and painful for 2 full days. Still slightly swollen at day 3.
Hives - on arms in circular pattern - rear elbow & forearm - odd shaped flat-raised areas  - come & go - dime sized - started 24 hrs after 2nd DTaP at 10 mo age - (sib with autism).
Fever,headache,cold/hot    sweats,bad muscle aches,no appetite,dizzy ,stiff neck ,stinky major sweat , uncomfortable no sleep   felt like i had the Corona virus...
The patient, was was 16 years old on the date of the adverse event, was vaccinated with the Moderna Booster Vaccine when the patient should have been given Pfizer. Patient experienced no symptoms or any adverse reaction to the vaccine.
This spontaneous report was received from a physician regarding a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot# and expiry not reported). On an unknown date the patient experienced induration, erythema, itching, warmth and "two small clear blisters" at the injection site following administration of ZOSTAVAX. The physician stated he felt that the blisters were "not vesicles" and he did not feel the blisters were indicative of a varicella or varicella-like rash. The outcome of the events were unknown. Causality was not reported. Additional information has been requested.
Left breast began leaking blood. It was a good bit. Had mammogram and ultrasound done 6-1 and no signs of any lumps.
Violent vomiting for two days followed by two seizures on 05/04/1998.
induration and erythema developed surrounding injection site (left deltoid), area of 17cm vertically by 11cm horizontally.  Some pruritis.  Injection was yesterday, came for evaluation today, course of treatment still in development due to need for further observation.    Pt. had initial Hep B series in late 1990, did not realize had prior series when this one was started; was discovered poring over prior records.