chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received on 16-JAN-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  Medical history, concurrent conditions, and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX on or about 13-OCT-2006, administered (by an unspecified person) at a physician's office, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-MAY-2010, the patient was treated by a physician/MD at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 15-JUN-2010, the female was treated again at the same medical center for ongoing and worsening pain at which time the diagnosis of herpes zoster was re-affirmed.  On or about 23-JUL-2010, the female patient was treated at a medical center for shingles with interference to the nervous system.  On or about 03-FEB-2014, the patient sought treatment from a nurse practitioner at a medical center for new outbreaks of herpes zoster. On or about 16-DEC-2016 (date as reported), the patient was treated for recurrent herpes zoster that manifested in persistent cluster outbreaks. On or about 15-DEC-2016 (date as reported), the patient was treated at the physician's office (same office where she received the vaccination on or about 13-OCT-2006) for uncontrolled pain accompanying her herpes zoster, as which time she was diagnosed with neuropathy caused by herpes zoster infections.  The female patient has been prescribed acyclovir, hydrocodone bitartrate (NORCO), prednisone, gabapentin (NEURONTIN), and amitriptyline for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX.   Upon internal review, the event of treated for Shingles with interference to the nervous system was determined to be medically significant. Additional information has been requested.
shingles; Missed 2nd shingles dose; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself/himself. The age at vaccination was not reported for 1st dose and it was not applicable for 2nd dose. The patient missed the 2nd dose, which led to incomplete course of vaccination. At the time of reporting, the patient had shingles. The patient asked if he/she needed to start over again with the 1st dose. Follow-up would not be possible as no contact details available.
Currently pregnant.  11/3: Started with just itching on day of vaccine.  11/4: Day two was more intense itching and tiredness.  11/5: Woke up with rash on arm/hands. Turned into hives and spread onto face and other arm. By time I had my OB appointment it had spread to be stomach, back and face.  My OB started me on a steroid with direction to go to ER if throat/tongue began to swell.  Benadryl did not work for itching on days leading up to rash.
ErythemaMultiform Sowllen lymph node rt gorin Narrative:  Recxomended Benedryl and Ice
throwing up; sore arm/arm is sore; head is itching; pain/soreness; stomach hurts; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent (patient's mother).  A male patient received bnt162b2 (BNT162B2), administration date 29Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "throwing up"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm/arm is sore"; PRURITUS (non-serious), outcome "unknown", described as "head is itching"; PAIN (non-serious), outcome "unknown", described as "pain/soreness"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach hurts".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a licensed vocational nurse referring to a female patient of unknown age who on 22-AUG-2013, was vaccinated with an expired dose of PNEUMOVAX23 (lot # 672370/1851AA, expiration date, 05-AUG-2013) 0.5 ml, intramuscular. No adverse event reported. Additional information has been requested.
ACHES/PAIN; FEVER; NAUSEA; This spontaneous report received from a consumer concerned a male of unspecified age. 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 not reported, batch number: Unknown) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination .The batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAR-2021, the subject experienced aches/pain.  On 28-MAR-2021, the subject experienced fever. On 28-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea and aches/pain was not reported. This report was non-serious.
Patient developed golf ball sized knot with redness surrounding the injection site.  Patient complained site was painful and hot that evening.  Ice applied to site the next day per doctor.
has experienced chest tightness; has experienced chest pain; inability to take deep breaths since receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  A 20 year-old female patient received bnt162b2 (BNT162B2) (Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious), outcome "unknown", described as "has experienced chest tightness"; CHEST PAIN (non-serious), outcome "unknown", described as "has experienced chest pain"; DYSPNOEA (non-serious), outcome "unknown", described as "inability to take deep breaths since receiving the vaccine". The events "has experienced chest tightness", "has experienced chest pain" and "inability to take deep breaths since receiving the vaccine" were evaluated at the physician office visit.  Additional information: She had been evaluated by multiple physicians who have not been able to identify reasons for these symptoms. After reviewing VAERS, and other creditable sources this seems to be a potential trend after receiving the vaccine and requesting a review of this information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
injured; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJURY (non-serious), outcome "unknown", described as "injured".  Additional information: The reporter asked if we did have a third-party insurance that may cover injury from the Pfizer covid-19 vaccine. The reporter said that they did have one member who told them that he was injured by Pfizer covid-19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Emergency nurse said erratic heart beat, in ER for about 2 1/2 hrs. Vaccine given and immediately had palpitations.
Patient reported getting a headache and rash in addition to restlessness at night and fatigue.
Shot given 7/1/08.  Arm was sore as normal.  Then 2-3 days later redness and induration continued to grow in size & became more painful & tender & swollen.  Treatment-ibuprofen, cold compresses & KEFLEX 500mg QID x7 days.
Vaccine administered 10:15am.  Got a headache and mild nausea 12:15pm (2 hours later).  5:15pm (7 hours later) started to shake violently.  Couldn't walk was shaking so much.  Speaking was difficult.  Breath was labored.  It was so scary my husband called the doctor.  Shook violently with teeth chattering for 45 minutes then would break for a few minutes before shaking again.  The shaking was probably 60 minutes total.  Then fever set in.  Fever hit 102.4 at 6:15pm.  102.9 at 6:40pm.  103.8 at 8:15pm.  Fever ranged between 102.3 and 103.8 for 8 hours after starting then finally broke 1:45am (8 1/2 hours after the shaking started).  Was able to get out of bed 8:00am today.  Massive headache for the morning but no fever today.  26 1/2 hours post vaccine new and I just feel very tired and drained.
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 76-year-old male patient received BNT162b2 (BNT162B2), on 11Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (Apr2022) positive, notes: I kept testing positive until 21Apr; (21Apr2022) positive, notes: I kept testing positive until 21Apr. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had received any other medication in 2weeks. The patient had received Paxlovid on 06Apr2022 for treatment of Covid -19 and stop on 11Apr2022. Other medication in 2weeks product was Breo, lot number=TP3U. 5 days after finishing Paxlovid he began having symptoms he had when he tested positive. They were less severe. By day 9 he felt fine. He kept testing positive until 21Apr.  No follow-up attempts are possible. No further information is expected.
No adverse event; 1st dose - 10Feb2021; 2nd dose - 11Jul2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 10Feb2021; 2nd dose - 11Jul2021) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy (Have been on chemotherapy prior to getting their 1st dose of the Moderna Covid-19 vaccine). Concurrent medical conditions included Immunocompromised.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 10Feb2021; 2nd dose - 11Jul2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 10Feb2021; 2nd dose - 11Jul2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication details were not reported by the reporter.  They have been on chemotherapy prior to getting their 1st dose of the Moderna Covid-19 vaccine and the condition for which they are receiving chemotherapy had been present since then. They also state that the condition remained they same since they got the vaccine.  On 28-Aug-2021, patient received 3rd dose of Moderna COVID-19 Vaccine, Batch number 043B21A. On 04-May-2022, patient received 4th dose of Pfizer COVID-19 Vaccine, Batch number  FK9894. On 05-Oct-2022, patient received bivalent booster dose of Moderna COVID-19  Vaccine, batch number 027E22A.  Treatment details was not reported by the reporter.
Wrong injection site/got the 1st shot in the triceps and not in the deltoid muscle; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Wrong injection site/got the 1st shot in the triceps and not in the deltoid muscle) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Wrong injection site/got the 1st shot in the triceps and not in the deltoid muscle). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Wrong injection site/got the 1st shot in the triceps and not in the deltoid muscle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.; Sender's Comments: This report refers to a case of vaccine administered at inappropriate site for mRNA-1273, lot # unknown  with no associated AEs
Client states she received the flu vaccine on 11/19/02 and on Fri 11/22/02 she noted a rash on the top of her thigh close to the hip joint. She bathed it with water as it itched. On Sat 11/23/02 the rash had gotten and she applied on antifungal cream x 2 that day. Had no fever Fri or Sat. On Sun 11/24/02 she still had the rash and applied on antifungal cream x 2 that day. No fever. On Mon 11/25/02 the rash had increased to the size of a quarter and see had no fever but the increased warmth to area and it continued to itch and she applied Bacitracin cream to it. States the rash really concerns her as well as the itching. Client states she was treated for a urinary tract infection on Sat. 11/16/02 at the health center. States the doctor prescribed an antibiotic named Septra one tablet po BID #14 and she took the last tablet on Fri 11/22/02. States she was also given a prescription for Pyridium one tablet po QID for bladder pain and discomfort and she stopped taking it on Thurs. 11/21/02 and she has nine pills left. States she was treated for bronchitis with an antibiotic on last year but she can not remember the name but she had no problems with it. Client states after she received the flu vaccine on 11/19/02 in her right arm she noted that the area was red for a couple of days but it went away. Client states she has no primary care physician. RN discussed signs and symptoms of local and possible systemic reactions to influenza vaccine and advised use of Tylenol tablets (if she can take it) for pain and discomfort and may apply a cool wet cloth or ice pack to rash fifteen minutes at a time only and then she needs to seek MD evaluation of the rash as it could be a possible allergic reaction to the Septra tablets on the Pyridium tablets that she had taken. Client verbalized understanding and stated she would seek MD evaluation.
A red area appeared at injection site on 01/23/21 at 8 A.M.  The reddened area was an inch in diameter.  Now the reddened area is 2 1/2 inches in diameter.  It has darkened center and is very itchy, especially at night.
On Monday, 3/26/01, 3 pts showed up at out clinic stating they had had very sore arms secondary to their pneumovax shot on Saturday, 3/24/01. This pt was one unusual occurrence sent to you. Pt stated left deltoid area "red and very sore" until 3/25/01 PM, at which time symptoms rapidly improved. No symptoms on 3/26/01.
no adverse effect; one dose of improperly stored MMR II was inadvertently administered; This spontaneous report was received from a medical assistant referring to a 7 year-old patient of unknown gender. The patient's pertinent medical history, concurrent condition and drug reactions/allergies were not reported. Concomitant therapy included diluent. On 07-OCT-2019, the patient was inadvertently vaccinated with one dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (data logger) (lot # R028003 with expiry date of 01-OCT-2020) (strength, anatomical location and route were not reported) constituted with properly stored diluent for prophylaxis. No adverse effects were reported. It was reported that the vaccine was exposed to a temperature above 47 degree fahrenheit for a time frame of 10 hours. There was no previous temperature excursion reported. No product quality complaint (PQC) was associated with this report.
COVID arm rash  on the third day, and other rashes with itchy feelings on the leg, back, belly. Had dizziness on the first and second day. Allergic dermatitis  Allergic reaction to COVID vaccine  Eczema
I had the shot and then had a light case/ suspected vaccination failure; I had the shot and then had a light case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult 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 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 Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient had the shot and then had a light case, he/she stated it was not fun. This case was considered as suspected vaccination failure as details regarding vaccination schedule and time to onset for target disease were unknown at the time of reporting.
Note: this was exactly 2 wks after my 2nd Pfizer shot; night chills, dizziness, nausea, headache
It was found that a box of 10 MENVEO vaccines were not reconstituted correctly so the patient only received half of the dose. Once discovered office was contacted, the manufacturer, and the patient was offered re-vaccination of the vaccine to provide complete immunity. The vaccine is Meningococcal conjugate MENVEO MCV40, manufactured by GlaxoSmithKline (GSK
I had a sore throat, tired/fatigue, heavy cough but no fever. I took an at-home COVID-19 on 12/31/2022 which came back positive. I contacted my physician and informed him of my positive test, so he prescribed me PAXLOVID. Due to the holiday weekend, I wasn't able to retrieve my prescription until 01/02/2023. I began it the same day, and as of now, a majority of my symptoms have subsided. I feel as if I've recovered, but I'm still testing positive at the moment.
I woke up with a red rash about 3 inches long and 1 inch across below the injection site. The injection site was blood red. The rash has been itching for the last three days. It is hot to the touch. I have been putting Benadryl cream on the site.
08/26/21 04:30pm Vaccination 09/10/2021 Very nauseated 09/13/2021 Went to Doctor and had labs drawn.  09/15/2021 Kidney function at 32%, A1C was 12.8, BP 77/74, eyes were blurred.  Eyes were blurry for 6 weeks.  10/03/2021 L side ankle, knee, foot weakness. MRI. ultra sound, Scan. Neg for clots. Had to wear a boot, crutches, and walking cane.  11/2021 Increased Calcium in blood. Chest x-ray; decalcification of lungs.  *constant pain / weakness in L leg, side.  *glasses has been fitted to my new current eye sight.  *No BP medications since it dropped Podiatrist 1x year Diabetes II newly diagnosed and monitored with medications.  Kidney function being monitored.  5 mg of Tradjenta 650mg sodium bicarbe x2 daily, 80mg Febuxostat 1 daily, c-baclo/q/gaba/lido 5% cream (for knee and foot)
Information has been received from a nurse practitioner concerning a 5 year old female who on 01/07/97 was vaccinated in the left arm with a first dose of  Varivax. The patient was seen in the physician's office on 12/26/01. "A few days prior to the office visit" (also reported as 12/26/01) the child developed numerous head to toe varicella lesions. She had no fever. Unspecified medical attention was sought. Follow up information indicated that on 12/26/01, the patient had a vesicular rash with various stages from papular to vesicular to 'crusty". It was noted that it was over the entire body. Additional information has been requested.
At 4:45 PM patient stated she had pain at injection site, headache, and slight dizziness. No discolored or swelling skin seen at injection site.  T=97.7