chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initially had arm pain in the left deltoid area with mild induration, chills and some bodyaches. Generalized fatigue. Two days ago(1/2/21) a large left supraclavicular lymph node came up, it is a little sore. No redness. Moveable. No coughing or SOB. No difficulty swallowing. No rash to that area. No sore throat or other known cause at this time for the adenopathy
Tenderness; Blotches around the injection site; tired; under the weather; Achy; This case was reported by a consumer via call center representative and described the occurrence of pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (10 years ago).   On 31st May 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 1st June 2019, 1 days after receiving Shingrix, the patient experienced pain, tiredness and feeling unwell. On 2nd June 2019, the patient experienced skin blotches. On an unknown date, the patient experienced tenderness. On an unknown date, the outcome of the pain, tenderness, tiredness and feeling unwell were recovered/resolved and the outcome of the skin blotches was not recovered/not resolved.   It was unknown if the reporter considered the pain, tenderness, skin blotches, tiredness and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix on Friday, before reporting date. On Saturday morning, the patient experienced feeling achy, described as feeling under the weather and tired. These events were resolved. Less than a week after receiving the Shingrix, the patient was feeling very tender to the touch almost like when she had shingles, to the area where the patient was having shingles approximately 10 year ago. The tenderness was getting better and the patient reported that she almost forgot about it until noticing blotches around the injection site last night of the reporting, that was not resolved. The reporter consented to follow up.
This case was reported by a nurse and described the occurrence of hives in a 44-year-old female patient who received FLUARIX QUADRIVALANET (batch number LY2F5, expiry date 30th June 2015). On 7th October 2014, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, unknown after receiving FLUARIZ QUADRIVALENT, the patient experienced hives and itching. The patient was treated with BENADRYL. On an unknown date, the outcome of the hives and itching were unknown. It was unknown if the reporter considered the hives and itching to be related to FLUARIX QUADRIVALENT.
Why is my arm still puffy and red at injection spot; my arm still has a big red area; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (my arm still has a big red area) and VACCINATION SITE SWELLING (Why is my arm still puffy and red at injection spot) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (my arm still has a big red area) and VACCINATION SITE SWELLING (Why is my arm still puffy and red at injection spot). At the time of the report, VACCINATION SITE ERYTHEMA (my arm still has a big red area) and VACCINATION SITE SWELLING (Why is my arm still puffy and red at injection spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  No treatment information provided.
Initial unsolicited report received from a healthcare professional via other company (Merck) on 02 January 2015. A male patient (age at the time of event not reported), whose medical history and concomitant medications were not reported had received an intramuscular dose of POLIO VACCINE (batch number, dose number and anatomical site of administration and not reported) vaccine on an unspecified date in February 2014. On an unspecified date after vaccination within minutes patient became flushed and developed a fever. Corrective treatment were not reported. Laboratory investigations: Allergy and skin test on an unspecified date revealed that the adverse reactions of flushing and fever were due to components formaldehyde and polymixin B in the polio vaccine. At the time of this report, patient outcome was unknown. List of documents held by sender: none.
CDC reports: 7 mo infant developed a fever of 105; had rash other than at inject site - "diaper rash" & hypotonic, hyporesponsive episode 2 days following immunization, duration of illness - 3 days.
First trouble sleeping, fever & itching at injection site night of vaccines(June 4, 2012). Then starting in the early afternoon of June 6, 2012 she broke out in hives on her upper left thigh. Last hives outbreak was September 2013.
sore muscles; feeling tired; Arm hurts; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2020, the patient received Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced myalgia, tiredness and pain in arm. On an unknown date, the outcome of the myalgia, tiredness and pain in arm were unknown.   It was unknown if the reporter considered the myalgia, tiredness and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but was selected as per the vaccine indication. On 1sy June 2020, the patient received shingles vaccine and experienced feeling tired, sore muscles, arm hurts. The patient asked was this normal.
Initial and follow-up information has been received from a physician concerning a 69 year old male consumer with no known allergies and a history of childhood chickenpox who on 22-FEB-2007 was vaccinated in the left upper arm with a single dose of zoster vaccine live (Oka/Merck) (lot # 656413/1477F). Concomitant therapy included allopurinol, simvastatin (MSD), HYTRIN, NORVASC, TOPROL XL TABLETS) and furosemide. Subsequently, on 28-FEB-2008 the patient developed a "severe case of zoster" and experienced pain. Unspecified medical attention was sought. At the time of the report the patient was no recovered. There was no product quality complaint involved. New information from the physician indicated he would be collecting a specimen for VZVIP on 10-Mar-2008. At the time of the report update, the patient's status was reported as uncomfortable and the patient was started on on FAMVIR at the time he was diagnosed with shingles. Follow-up information from the physician indicated that there was no rash at the site of injection or elsewhere within 42 days of vaccination. The patient's pain was reported as 8 on a scale of 0 to 10 and the patient's maximum temperature was reported as 100 degrees F. There was no recent exposure to chickenpox or herpes zoster. The patient developed 8 clusters of vesicular lesions up to 3.5 cm in diameter on the right T12 location. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. The sample of the lesion was collected on 10-MAR-2008 and sent to the laboratory on 10-MAR-2008. The sample was taken from a crusted lesion. The PCR results for the specimen from a crusted lesion identified the presence of WT VZV. Follow-up information from the physician indicated that the patient recovered on an unspecified date. Additional information is not expected.
missed the 2-6 month window for their second dose of Shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: missed the 2-6 month window for their second dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 09-JUN-2023 Sales representative submitted the following for a physician. The physician asked what to do if a patient missed the 2-6 month window for their 2nd dose of Shingrix. He asked if the patient should restart the 2nd dose series. They did not spoke with the health care provider. Till the day of reporting the patient did not received the second dose, which lead to incomplete course of vaccination. The reporter asked to follow up the Sales representative for more information.
Sores, Pain, Rash like condition on inner thighs. Diagnosed by physician as chicken pox, reaction from vaccine.
Patient has had persistent aching pain in her right lateral deltoid since vaccine administration 6 months ago.  I have referred her to physical therapy to regain range of motion.
devel Bell's Palsy p/vax;required w/u including MRI & course of pred;
Information has been received from a registered nurse concerning a 13 month old healthy female with no allergies who on 09/12/2001 at 2:30pm was vaccinated with a dose of varicella vaccine SC in the left thigh. On that day at the same time, she was also vaccinated with inactivated polio vaccine SC in the right thigh. Within five mins the child developed a shingle hive. The hive was the size of a dime, it was white with a red erythematous border and appeared 1/4 inch below the injection site. There was no shortness of breath, rash or other hives. The pt was given Benadryl and the hive began to disappear within 20 mins. She recovered within two hours. According to the nurse, there was no reaction at the site of the polio injection. It was also noted that the pt's twin sister also had the same reaction.
Significant joint inflammation (knuckles, knees, ankles); inflamed achilles tendons (both); lower back pain; extreme malaise. I basically had to stay in bed for 36 hours. Injection site swelled to make a one inch bump.
Symptoms of difficulty breathing, feeling tingly and numb in his arms and upper body. Passing out weakness in his arms, happened on the same day of vaccination. Office notes 9/25-9/26/06: Complains heart seems to beat faster, breathing fast and feels lightheaded. Episode on Friday when he was at track, doing sprints heart beating faster, hard to breathe, fell to ground and passed out then was okay. Occurred again next day while sitting in chair. Tired over weekend, and that is how he acts after that happens. No headaches, no vision changes, feels lightheaded prior to passing out. Hard time sleeping at night, starts thinking about his breathing and then it is harder to sleep. If he gets nervous he will notice that his hands shake. Otherwise he has noticed no tremors. If he is not nervous the hand shaking does not seem to be there. No other jerking movements. PE: WNL. Observed in office and he became anxious and started breathing faster. Heart rate 100 hands seemed shaky, no syncopal episode associated with this.  Discussion that it could be anxiety related.  8/26/06-office visit:observed in ER 2 syncopal episodes. Mom indicated he drinks a lot of sports drinks with high caffeine and Mountain Dew. Recommend avoiding these drinks, referred to neurologists for hand tremors.  ER DOS 9/25/06: DC DX: Syncope and palpitations. Seen in ER for C/O syncope and palpitations. previously seen in ER on 8/10/06 with C/O: Drunk. While at a bonfire patient suddenly started being real tingly and passed out. Hard time breathing. Hyperventilating. States he could not more his arms or feel them, however, he adamantly denies drinking alcohol or taking any medications. Stated had Hep B vaccine on 8/10/06. Fainted while sitting in chair by bonfire. EMS arrived, VS normal, awake except for mild tachycardia and was hyperventilating. Temp 100.0. PE: WNL. Neuro: normal cranial nerves, DTRs equal and symmetrical bilaterally. Normal sensation.  Final impression: syncope and fever most likely secondary to hepatitis B vaccine.
Administered Pfizer primary series vaccine instead of intended bivalent dose; no ill effects reported, patient aware and is eligible for bivalent in 2 mos
Sore throat, ear discomfort, runny nose, chills. Subsequent headache added to symptoms. 4th day now with all symptoms.
Myocarditis, chronic urticaria/dermatographia, difficulty breathing, blueish/purple/yellow/cold hands and feet
Vaccine breakthrough. Had varicella vaccine 9/3/97. Developed rash 6/5/05. No fever. Diagnosed with varicella in our office 6/6/05. Less than 50 red, papular lesions on face, trunk, arms; some crusted. Diagnosed by PNP.
This spontaneous report as received from a nurse refers to a 15 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 22-APR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 3, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2012, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2014, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
This spontaneous report was received from a healthcare worker and concerns an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (having lot # as L019297 and expiration date as 18-AUG-2017) (dose number, dosage and route of administration were not reported). No concomitant therapies were reported. No previous excursions had occurred. This temperature excursion occurred at 50 F for a time frame of one hour. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Mild fatigue and body aches began about 10 hours after the vaccination and lasted about 36 hours.  Tinnitus began 5 days after the vaccination, and persists.
SPOT ON ARM WAS LITTLE SENSITIVE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. 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 experienced spot on arm was little sensitive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spot on arm was little sensitive. This report was non-serious.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patient's concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (dose and route were unknown, lot # K016966 with expiration date 10-MAY-2017, lot # K010214 with expiration date 05-MAY-2017, and lot # K011562 with expiration date 08-APR-2017). The vaccines were exposed to temperature excursion of 57.0 degrees Fahrenheit (F) for 1 hour and 50.8 degrees Fahrenheit (F) for 1 hour. No previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sore arm at injection site, fever, chills, headache, muscle aches, lethargy July 31- August 2. The headache lasted from July 31 through August 5. Since then the headache is in the morning. Now there is a tingling sensation on the top of my head.
Feeling hot w/o a real fever; feel achy, dizziness; loss of coordination; severe headaches, fatigue when performing normal activities (walking from one room to another in my home, taking care of personal hygiene); loss of appetite.
just admitted to the hospital with chest pain; This is a spontaneous report from a contactable consumer (patient's relative).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19, Batch/Lot number and expiration was not reported via an unspecified route of administration on an unspecified date as second dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got received the Pfizer COVID vaccine second dose recently and he was just admitted to the hospital with chest pain on an unspecified date in May2021. They did a heart catheterization and found that they didn't feel that the patient had any blockage, and they were keeping him in hospital for monitoring and that for the reporter had information of the heart, but didn't have much details. The patient just had been kept in hospital for administration through the weekend. Currently, the patient was still in hospital. The outcome of the event chest pain was unknown.  Information related to batch/Lot no. was requested.
The day after vaccination patient developed a rash on her vaccination arm.  She described that it lasted several days and then went away.  The rash returned a few days later and this time she described it as being "bumpy" and included some swelling in the lymph nodes under her arms (both sides).  After a few more days the rash and swelling went away.
Right sided facial rash and itching  and bilateral eye swelling developed 1 hour vaccine administration. Treated with Benadryl, Naproxen and Claritin. Itching resolved on 1/11/2021 and eye swelling and rash resolved on 1/12/2021
Blood clots and bruising lasting over 4 months now.So far only affected both arms.
Mother noted 11/20/08, at approx. 3:00 p.m, Rt arm of child appeared bright red with "bumpy type rash, approx. 2" width x 4" length in area below injection site. Child stated it was itchy all day at school.
Client stated he did not like needles and did almost pass out last time he got a vaccine. Client was given moderna vaccine in left deltoid and was asked to stay seated, but the client said he felt fine, that it was a small needle so he was allowed to walk to the waiting area and went to get a snack also. About 5 min after this I was called to the client as he was being lowered to the ground by his sister and MA with department. The client was unresponsive for about a min. We raised his legs and he regained consciousness soon after, and was able to open his eyes and  talk. About 3 min later client sat up on the ground, no other injuries per the client. A few minutes later he got himself up and sat on the bench. Still a little pale and diaphoretic. About 30 min after receiving vaccine he felt much better and said he was ok to leave and go back to work.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2021 at 17:30 as dose 4 (orange cap; booster), single (Lot number: FK5127) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MONTELUKAST, start date: 01Jun2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 21Jun2023 to 25Jun2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300238451 Same patient and product, Different dose and events;US-PFIZER INC-202300237631 Same patient, Different product and events;
Upon immediate administration of vaccine, patient felt dizzy, sustained altered mental status and started to lose consciousness.  Patient was placed supine on an exam table where he appeared to start convulsing and frothing at the mouth.  Patient regained consciousness after a few seconds and could start to answer questions regarding his location and name.
Started with chills and shakes, then full body aching and bad headache. Lasted for 24 hours. Significant swelling and sensitivity at injection site started in the evening and is still present.
Between 9/20-9/21 - patient developed unilateral rash on right back radiating/spread to armpit and chest. He has decreased vision in R eye. He has pain, swelling, redness at rash. He is following up with family doctor today 9/23/13.
Vaccine did shed and gave shingles to wife and son.  Son, has had a kidney transplant, and heart surgery, now battling shingles after exposure from his father on August 5, 2019, wife also broke out in shingles when the itching began on August 5, 2019.  It is stated that Shingrix does not "shed"...however we are living proof in fact that Shingrix does and did shed and infect 2 family members with shingles. We currently are battling the aftermath of a filthy infectious vaccine.  Both son and myself are covered in shingles sores, still, as of Aug 16th.