chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a certified nurse midwife through a Merck pregnancy registry for varicella virus vaccine live concerning a 16 year old female with a urinary tract infection, no history and no allergies who on 17JUL2003 was vaccinated with varicella virus vaccine live (lot 641991/0323M). Concomitant therapy included nitrofurantoin early in the pregnancy for the UTI and vitamins. It was reported that the patient later found out she was pregnant. Her LMP was 01JUL2003 and her expected date of delivery is 08APR2004. It was reported that there was no indication of problems with the pregnancy, 4 ultrasounds were normal and a urine pregnancy test was done. It was noted that the patient did have an "elevated AFP, alpha fetus protein". Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.  Follow up information from a nurse practitioner indicated that the patient had a history of 1 pregnancy that resulted in full term birth. There was no local reaction, varicella symptoms or herpes zoster symptoms post vaccination. On 3/12/2004, 37 weeks from LMP, the patient delivered a female infant weighing 5lb 12oz. It was reported that the infant was normal. There were no congenital anomalies and there were no complications. It was reported that at 10 days of age the infant was seen by a physician for followup on jaudice. It had resolved and there were no other concerns. The infant was subsquently vaccinated with hepatitis b vaccine (manufacturer unknown) and experienced adverse events (WAES 0601USA00985) Additional information is not expected.
Highest fever on the shot; 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 PYREXIA (Highest fever on the shot) 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 PYREXIA (Highest fever on the shot). At the time of the report, PYREXIA (Highest fever on the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.    Reporter did not allow further contact
Vaccine is from 2017-2018 formula but was administered in 2019. Vaccine expired 11 May 2018/no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of unknown demographics who received an expired dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (UI871AB) (expiry date: 11 May 2018).  It was of actual medication error case due to expired vaccine used. Vaccine is from 2017-2018 formula but was administered in 2019.  It was unknown whether adverse event was noted or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
After 5 or so days I developed my first outbreak of dyshidrotic eczema.  I?ve had the tiny bumps appear before but this time the itchy sensation was more intense and i itched which made a rash on my hands ,  feet and left elbow develop.  I?ve had it for a number of days now.
Dose was given very high on the shoulder I have had pinching pain limited muscle mobility and muscle weakness ever since.
Painful bumps under my skin upper thighs. continue to appear. Very painful when first come out. Pain scale 1-10 daily 3-7
Pain increased in armpit of left arm where Tdap was given. Today is 10/12/2012 and there is a softball size swelling in my armpit of the arm in which the shot was given. I had a flu shot in the right arm on the same day. Outcome: yet to be determined. Plan: rest, fluids and time.
Client states after receiving pneumonia vaccine on 10/15/02 at 2pm she began having chills and R upper arm swelling. States she felt bad all night and RUE continued to swell and was warm to touch. Continued with swelling and redness and was seen by physician on 10/17/02.
The adverse reaction was with my son who is breast fed not with my wife.  On June 28th we took our son  to the doctors for a normal 6 month visit and showed them some of the bruises he had on his arms caused by our daughter grabbing his arms.  They asked normal questions about any bleeding he may have had from circumcision or past shots and we told them none. They said the bruising is okay but to be careful with how our daughter plays with him.   He got his 6 month shots and we went home.  My wife noticed that he was bleeding through the bandaids and his shorts so we went back to the doctors office. They were now concerned and sent us to Hospital. Hospital did extensive blood work and ruled out things like Leukemia and things like lupus for now since his red and white blood cell count was normal. However his Platelet Count is extremely low.   They think he was experiencing ITP or Immune Thrombocytopenic Purpura. His platelet count was 5 and should be between 159-350  His body thinks he has a virus and is attacking his platelets. They treated him with immunoglobulins.    Update on son. A normal platelet count should be between 159-350 was 5.    The infusion of immunoglobulins he got last night worked. He got his results back and they were good news.  He increase to 132 and then 218.   The hope is that he will maintain or increase the platelet count from here on out.  He?s had a few blood tests last week and his count is very high and hopefully will level out.   My concern is this:  My wife had her 2nd Pfizer shot on June 9th. We started noticing the bruising on or around the 12th or 13th.   I?ve asked at least a dozen doctors and nurses if the virus that my son?s immune system was fighting could have been caused by my wife?s 2nd Pfizer vaccine since she breast feeds. No one can give me an answer nor will they do any testing. Not to mention my son is a COVID baby. My wife and I both had COVID while she was pregnant with him.   If anything you would think someone would care enough to at least test him for COVID or the antibodies. But no. Everyone just blows me off.   Maybe what happened to him and his case could save another little babies life. If it wasn?t for the bruising on his arms caused by my daughter who knows what could have happened. Some doctors say he could have had a brain bleed and died.
Patient claims that she got cellulitis from receiving covid shot at pharmacy on 08/31/21. Her arm became red and swollen and three days later she visited Urgent Care where they made cellulitis diagnosis. She was prescribed antibiotics  and rash cleared up but she still has remaining pain all the way down from shoulder through elbow and forearm.   also stating A-fib has worsened from 3-6 and it had previously been under control.
Parent reports that 8 hours post vax the pt developed a 100F temperature. Two days post vax pt was seen my MD with a quarter size lump on left thigh, sleepy and difficult to awaken.
Vasovagal syncope after roughly 13 minutes post-injection. Syncope lasted a few seconds (roughly 10 seconds) according to family that helped me. Head went backwards and eyes rolled back in head and then head/body slowly moved forward/sideways. Treatment or follow-up was not provided by anyone at pharmacy location even though family asked for assistance. I left after the 15 minute mark that I was required to stay for. My head felt very tight for the rest of the day, like a rubber band was squeezing my head around both temples.
Symptoms:  Lightheadedness after 2nd dose of Pfizer. Had no issues with first dose.   Treatment:  Given juice and crackers and observed for 40 minutes. Felt better, VSS, sister drove her home.
Around 10:30am on Saturday 9-15-18 - she developed shakes, flu-symptoms, slight fever. She felt better around 4:00pm. Her arm developed a red welt about the size of her palm at the administration site. She felt the flu- symptoms for a couple days.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. on 3/12/21 she was diagnosed with encephalopathy and NSTEMI. ON 3/29/21 she was diagnoses with catatonia, altered mental status.
hearing loss in her left ear; ear infection; tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, Lot Number/Expiry Date: EW0173, Anatomical Location: unknown), administration date: 14May2021, when the patient was 75-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Single, Lot Number/Expiry Date: EW0167/unknown, Anatomical Location: unknown), administration date: 05Jun2021, when the patient was 75-year-old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Jan2022, outcome "not recovered"; DEAFNESS UNILATERAL (medically significant), outcome "not recovered", described as "hearing loss in her left ear"; EAR INFECTION (non-serious), outcome "not recovered". The events "hearing loss in her left ear", "ear infection" and "tinnitus" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of ear infection.  Additional Information: Caller reported that she had received her first two doses and booster dose of the Pfizer Covid-19 vaccine. Caller reports that she was having a lot of problems after booster dose of the Pfizer Covid-19 vaccine. She was having complaints of an ear infection after the booster dose of the Pfizer Covid-19 vaccine, took a dose of antibiotics, the ear infection did not clear up, took another dose antibiotics, and was then having complaints of tinnitus and hearing loss in her left ear. Caller stated that she did not know what to do about these complaints. After the booster dose, she was diagnosed with an ear infection. She was given an antibiotic, but the infection did not clear up, and was given a second dose of antibiotic. Stated she was given two doses of an antibiotic, and the medication did not help with the infection. Medication: Amoxicillin 500 mg. Vaccination Facility Type was at a pharmacy. Vaccine was not Administered at Facility. Adverse events required a visit to the Emergency Room. Discharged and referred to Ear, Nose, Throat specialist. Physician Office was also required. No prior vaccinations (within 4 weeks). Stated that Doctor looked in her ears and said nothing was wrong with her ears. Because of her hearing loss, she made another appointment for 25Jul2022. Stated she was given two doses of an antibiotic, and the medication did not help with the infection. Product strength and count size dispensed: 500mg/20 pills for 10 days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received vaccine and spot was not bloodied.  When returning home and later taking off the bandage father states there was a lot of blood that required two cotton balls to clean up and they put another bandage on it.  Patient was not treated and is ok.
Service member recieved SP vaccine(3 pricked, anthrax #1 and PPD 02/25/2003). On 02/27/2003 he received 2nd SP vaccine (15 pricks). He had no c/o SOB, chest pain , nausea, vomiting, fever, headache, or rashes. Also no reported swelling art site , increased lymph nodes.
pt recvd vax & 1 wk & 1 day p/vax pt collapsed, clenched teeth & twitched; pt taken to hosp seen by MD; pt stopped breathing, ahd sz activity; fever @ ER 102.9 R:
Sept 1 vaccine, Sept 6-7 sharp shooting pains in inner ear; one ear one day the other the next.  Sept 18th evening resting heart rate in mid 90's (typically 68).    Was taking 4 Motrin which helped a little.   I could not sleep due to heavy heart beat / palpitations, chest heaviness and shortness of breath.  Out of desperation, I took Valtrex (anti-viral) I had on hand and it helped alleviate the heavy heart beat and heart rate went down a little allowing for some relief.
I had three shots and I just got shingles/Suspected vaccination failure; I just got shingles; Very painful still; I had three shots; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and extra dose administered. On an unknown date, the outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 12-June-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient stated that you could still get shingles. The patient had three shingles shots and just got shingles. Not as bad as with out the shots but very painful still. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles not provided.
Vaccine on 6/2/11. On evening of vaccine pt developed fever T-100.1 -> next day T increased to 101 & on 6/4/11 T=102. Local effect of redness & swelling.
5/11/2021 RASH, RUNNY NOSE, NASAL CONGESTION DIARRHEA 5/12/2021 TEMP 103 F, NO APPETITE, NASAL CONGESTION
Severe headaches which has not subsided; severe vomitting, severe diarrhea and stomach cramps, body aches, fever, chills.
In June 2021 the growths began developing. I developed two growths on the ring and pinky fingers of my left hand they were diagnosed as excision lesion cysts mass and are painful with some joint pain involved. I have surgery scheduled to remove them 4/19/22 with the doctor.
Information has been received from a medical assistant via a company representative concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with the first doses of GARDASIL 9 (lot #, expiration date, dose and route were unknown). The patients did not come back on time for their follow up doses of HPV product. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not want to be contacted.
Pt had pain, swelling and redness in left arm that went down her arm that was size of a large apple.  She also had fatigue, nausea, chills, headache, all over body aches with no fever.  She felt like pins and needles were sticking her in the skin around the vaccination site.  She took Tylenol 500mg.  She was very tired so stayed in bed for about 4 days.  Her symptoms lasted a couple of weeks but still to this day she has days that she still gets tired, nauseated, and achy.
Narrative: 72 yo male died on 12/19/2021. Pt has record of one covid vaccine given on 8/21/21. No info since 2008 in medical chart. Pt's problem list from 2008 below: PROBLEM LAST MOD PROVIDER HTN (ICD-9-CM 401.9) 06/15/2007 Dupuytren's Contracture (ICD-9-CM 728.6) 6/15/2007 Prolonged posttraumatic stress disorder 12/28/1995 (ICD-9-CM 309.81), Onset 00/00/1993 Adjustment reaction with brief depressive 12/28/1995 reaction (ICD-9-CM 309.0), Onset 00/00/1993 Deviated nasal septum (ICD-9-CM 470.), Onset 12/28/1995 00/00/1993 Major Depressive Disorder, Single Episode, 12/28/1995 Unspecified (ICD-9-CM 296.20), Onset 00/00/1993 Other and unspecified alcohol dependence, in 12/28/1995 remission (ICD-9-CM 303.93), Onset 00/00/1993 Allergic rhinitis (ICD-9-CM 477.9), Onset 12/28/1995 00/00/1993 Acute upper respiratory infections of 12/28/1995 unspecified site (ICD-9-CM 465.9), Onset 00/00/1993 Depression, Neurotic (ICD-9-CM 300.4), Onset 12/28/1995 00/00/1993 Alcoholic gastritis, without mention of 12/28/1995 hemorrhage (ICD-9-CM 535.30), Onset 00/00/1994 Acidosis (ICD-9-CM 276.2), Onset 00/00/1994 12/28/1995 Not able to assess any information about pt's death and if related to covid vaccine. Pt's home address in another state. Likely pt moved there.
Patient received the first vaccine dose while being pregnant; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Patient received the first vaccine dose while being pregnant) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 05-Jul-2020 and the estimated date of delivery was 12-Apr-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Patient received the first vaccine dose while being pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy. The vaginal delivery occurred on 15-Apr-2021, which was reported as Full-term. For neonate 1, The outcome was reported as Term Birth w/o Complications. Baby was female and baby details was reported as weight 3.8 kg, length 52.07 cm currently patient was breast feeding. At the time of the report, EXPOSURE DURING PREGNANCY (Patient received the first vaccine dose while being pregnant) had resolved.            On 20-Apr-20, the patient has a previous pregnancy that ended in miscarriage. The patient reports prior usage of marijuana once monthly from Mar-2002 to 2018 The patient reports current usage of alcohol 5 drinks per week. Ultrasound test was performed on 27-Aug-2020, 08-Sep-2020 and 19-Nov-2020 and showed the result as normal.   This case was linked to US-MODERNATX, INC.-MOD-2021-101819 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: patient demographics was updated , LMP was updated, fetus infant details were updated, concomitants were updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101819:
This spontaneous report was received from a pharmacist refers to a male patient of unknown age. No pertinent medical history and drug allergies reported. On an unknown date in February 2014 the patient was vaccinated with a dose of ZOSTAVAX, 19400 PFU subcutaneous (dose unspecified). No other concomitant therapies reported. On an unknown date in 2014 the patient developed redness, swelling and bleeding at injection site. The patient sought medical attention. The pharmacist reported that the patient's arm continued to bleed at the injection site until an unspecified date in June 2014, until he was seen at an unspecified dermatologist, where the area was cauterized. The pharmacist inquired if this has ever happened to any patient before and had inquired why this has happened. Lab diagnostic test were unspecified. The pharmacist reported that the patient came back recently and reported that injection site had stopped bleeding after cauterization. The outcome of the events redness, swelling at the injection site was reported as recovering and the outcome of bleeding at injection site was reported as recovered in 2014. Causality was not reported. Additional information has been requested.
Exhaustion/fatigue, headache, body pains/aches including feet - set in the morning following the vaccinations (approximately 12 hours after) - symptomatic treatment  - recommended TYLENOL/ibuprofen for headache/body aches.
On 3/8/21, 13 days after receiving dose #2 of COVID19 series, patient developed erythema nodosum - painful erythematous palpable lesions starting on lower legs, then spreading to upper arms, with significant swelling of ankles that worsened over the next few days and caused difficulty walking due to pain. As of today, continues to worsen.
Four days after receiving the Moderna second dose, I had a pulmonary embolism of my right lung. It was diagnosed only on Feb. 19, as I was totally unfamiliar with the symptoms and had another indication of a problem: tachycardia, so went to the clinic. I am not sure this isn't coincidental, but I have no history of embolisms, and no family history. No one at the time of my diagnosis asked when I gotten vaccine. As I said , this may be entirely coincidental, or it may not.  I am presently on eliquis blood thinners, and have had no further problems.
Right nasal herpes simplex outbreak. Pt previously unexposed/symptom free. Therapy - Famvir.
Pt did not indicate on her consent form of any high risk conditions or receiving any vaccines prior. However, per the COVID registration system. Pt received a dose of Janssen on 4/9/21 and another independent pharmacy.  Pt never disclosed this information to us. Based on the current CDC guidelines, those who received Janssen should not get another vaccine at this time.  Pt never reported any adverse events to pharmacy.
Patient visibly pale upon sitting. Patient reported feeling lightheaded, dizzy and having blurred vision. Patient denies allergies or any medical history. Patient evaluated by NP and EMT. VS taken: BP 122/103, O2 SAT 99 on room air and pulse 69.
I had immediate, sharp, and severe pain at injection site that has not resolved 12 hours later.  I suspect injury to my anterior branch of axillary nerve.