chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. In 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 07-JUL-2015, patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. Patient was prescribed acetaminophen (+) oxycodone hydrochloride (PERCOCET) and lidocaine for management of his painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).
Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves female patient of an unknown age who experienced high fever, diarrhea, lots of coughing and mucus, while she received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious high fever, diarrhea and lots of coughing and mucus within hours following the administration of INFLUENZA VACCINE. (Other relevant tests included no lab data.) Final diagnosis was lots of coughing and mucus, diarrhea and high fever. It was not reported if the patient received a corrective treatment. The outcome of the event was reported as Unknown. Documents held by sender: none.
Rash located on chest, abdomen, R upper extremity and R lower extremity. Inj administered 4/25/16; pt seen in office 4/26/16. Pt was not uncomfortable and breathing well.
coughs with the irritation; his throat burns; he has had a lot of throat infection kind of feeling, like something is pressing on his throat; This is a spontaneous report from a contactable consumer (patient).   A 41-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection Batch/Lot Number: ER8730; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in arm left on 28Apr2021 at noon (age at vaccination 41 years) as dose 1, 0.3 ml single for covid-19 immunisation. There was no patient's Medical History (including any illness at time of vaccination). Family Medical History included his mother has low blood pressure issues. She had open heart surgery 25 years ago and that is it, there is nothing else that he can think of. The patient's concomitant medication were not reported. To get prevention from COVID the patient taking Pfizer COVID vaccine. He doesn't have any medical conditions which are serious. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. There was no prior Vaccinations (within 4 weeks). There was no AE following prior vaccinations. He received the vaccination 28 Apr 2021, that was his first dose. He noticed he has had a lot of throat infection kind of feeling, like something was pressing on his throat. The feeling with his throat from the second day. He did not really pay attention. He clarifies he took it on a Wednesday and he noticed it on Friday but since it has been going on for a week or something he did not know if it was some kind of condition. He had 2 friends that also had the Pfizer vaccination and they just were feeling tired, nothing of such like he was having, they had like flu-like symptoms, no further information provided. His side effect has been more than a week so he was thinking was this something that has to be considered, should he go see a physician. He confirms the feeling in his throat began 30 Apr 2021. It was ongoing. When asked if it has improved persisted or worsened, he says if he drinks hot water it was okay but then after that it becomes worse and a more constant condition and he coughs with the irritation. He says it was a lot of irritation and it causes cough and the his throat burns, it was that kind of situation. He just wanted to know whether he should be concerned or if he should go to his family doctor to report this or take any medicine. The outcome of events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On an unknown date, starting on or after 13-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L050560, expiry date: 14-DEC-2017) (strength, dosing details, anatomical location were unknown). No adverse effects were reported. It was reported that the vaccine was exposed to the temperature 10.67F for 12 hours. There was no previous temperature excursion. No product quality complaint was filed. This is ne of several reports received from the same reporter. Additional information has been requested.
Information has been received from a consumer regarding herself a 78 year old female with an allergy to Aspirin and penicillin, concurrent conditions were not provided. The patient reported her medical history as "none" and she reported that she had never had shingles before. Concomitant medication included vitamins (NOS). On an unspecified date (noted by the patient as "a few years back") the patient was vaccinated with ZOSTAVAX, "2-dose administration of the vaccine," (route and lot# unknown) for prophylaxis.  The patient also received sterile diluent (MERCK), (route and lot# unknown). The patient reported that she was diagnosed in February 2017 (also noted as, "a few years later") with shingles in her left eye and that she had a relapses in August 2017 and November 2017. The patient also wrote in an email "I contacted a very severe attack of Shingles/Herpes Zoster which has affected my left eye vision. Not only did I get the shingles, but had two relapses with a threat of vision loss. Treatment to get my vision back since February 2017 is still on-going with an Ophthalmologist for more than a year now (15 months now)." "I was visiting the doctor once a week and now I visit once a month. I take an (unspecified) antiviral medication and Prednisolone eye drops. At first I had to take the eye drops every 3 hours but then they tested my eye and I could see a little light so they reduced it to 5 times a day." "I have blurry vision in my left eye. I don't know if I'm legally blind. I may have to take medicine for the rest of my life. It's been more than a year and I'm trying to restore my vision in that eye." The patient is requesting that Merck & Co., Inc. provide assistance to pay for SHINGRIX which was recommended for treatment plus the medications and medical expenses since the diagnosis. The patient also mentioned that she has kept receipts for all the medical/Rx expenses. "I was told that I might have to continue the eye drops and anti-viral for the rest of my life." "Blurry vision in my left eye. I don't know if I'm legally blind" was considered disabling. Upon internal review "I have blurry vision in my left eye. I don't know if I'm legally blind" and shingles in her left eye were considered medically significant events. Additional information has been requested.
Syncope with mandible and mastoid fractures - patient is a nursing student, was standing, observing an epidural procedure, felt suddenly hot, passed out, no observed seizure acting or confusion, came to quickly.
Expired FLUMIST was given at 400pm. No reaction. Manufacturer was notified as well as staff from Public Health office.
Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL (lot # L006549 with expired date 06-APR-2017, dose and route were unknown). No concomitant therapy was provided. No adverse effects were reported. Additional information has been requested.
death certificate: Cerebral Anoxia; Pulmonary Congestion; SIDS time of death 6:21 a.m.
Itchy; Delayed rash reaction under her right breast; very slightly painful; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy), RASH (Delayed rash reaction under her right breast) and RASH (very slightly painful) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Partial mastectomy (Right-side partial mastectomy in 2007) in 2007. Concurrent medical conditions included Drug allergy (Allergic to Darvocet), Drug allergy (Narcotics (with Tylenol).), Hypertension, High cholesterol and Sinus infection. Concomitant products included LISINOPRIL, ATORVASTATIN and MONTELUKAST for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Itchy), RASH (Delayed rash reaction under her right breast) and RASH (very slightly painful). The patient was treated with CORTISONE at an unspecified dose and frequency and BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN TOPICAL) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itchy), RASH (Delayed rash reaction under her right breast) and RASH (very slightly painful) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-036167 (Patient Link).
Pt took oral typhoid on 04/01/2005, 04/03/2005, and 04/05/2005- reports on 04/02/2005 felt lightheaded " slumped over at veternarian" abdominal cramps and fever. No headaches or diarrhea. Decreased appetite, stomach continues to feel queasy and fatigue. Instructed to not take last dose of oral typhoid. All symptoms resolved on 04/21/2005.
Back stiff, severe pain in the center of back to the neck, expanded to front and back rib cage and right back should blade area. Continued for 4+ weeks.
Acute left-sided sensorineural hearing loss occurred 7 days after vaccine.  ENT visit, no improvement with prednisone.   Planned follow up 5/11/21 with possible steroid injection.
After 1 hour, developed chills, rising fever up to 104 degrees. Facial swelling, unresponsiveness with eyes rolling & somnolent appearance. Taken to urgent care - emergency room.
The symptoms began 8 days after the vaccine. They are only local: redness, swelling, and slight itchiness.
11 hours preceeding injection,high fever, chills, dry mouth,ache, large muscle cramps in legs weak feeling. low grade fever after.
I was diagnosed with Graves? disease starting in April 2021.  This occurred just 2 months after my last dose of moderna
Initial report was received 02 October 2009 from a consumer. A 30-year-old male patient with no concurrent illness or pre-existing medical conditions, had received a left arm intramuscular injection of H1N1, lot number UP001AA on 30 September 2009 at 11:00 PM, and approximately 8 hours later (also reported as 8.5 hours later), he experienced dizziness, a fever of 101.2 degrees and radiating pain from the vaccination site to the neck area. The events did not require a doctor's visit. The patient had previously received an intramuscular right arm injection of FLUZONE SV (lot number not reported) on 19 September 2009. At the time of the report, the patient reported that all symptoms had resolved. Follow-up information was received from a health care professional on 20 November 2009. The patient recovered within one week, and did not require any treatment for the events. FLUZONE lot number was reported as UP001AA (not a valid FLUZONE lot number). Follow-up information was received from a health care professional on 02 December 2009. The FLUZONE lot number was reported to be U3213AA. No other information was provided. Follow-up information was received from health care professional on 06 August 2010. The patient received FLUZONE on 19 September 2009 and the lot number was corrected to UP001AA with an expiration date of 09 March 2011. The patient reported on 12 October 2009 no fever, dizziness or pain at that time. The treatment received was reported as none. Documents held by sender: None.
Swollen left and nauseous, felt weak. Monday April 30th went to doctor. Patient was given a Kenalog shot, RX's for Bacterium and Ultram. Patient throw-up several times. Tuesday May 1st went to ER C/O nausea, muscle fatigue, and headache. Patient was given another steroid shot, bag of Normal Saline was infused for severe dehydration. ER doctor Discontinued the Bactrium and Ultram. May 2nd Patient still complaining of headache and nausea. Tueday May 1st; went to ER.
This spontaneous report was received from a pharmacist via a company representative referring to six female patients of unknown age. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with a dose of ZOSTAVAX (lot#, dose, route unspecified). Other suspect and concomitant therapies were not reported. On unknown dates, the six patients developed injection site reactions after receiving ZOSTAVAX. The reactions for each patient were the size of an "egg" and the injection sites involved swelling and itching. The outcome of the events was unknown. Additional information has been requested.
Patient received 2nd dose of vaccine at 4:15pm. 15min later had left arm pain and numbness on the left side of body. She seemed very anxious and distressed. did not want labs or imaging, got anxiolytics and Tylenol and symptoms resolved in 30 minutes.----per MD
pt would not arouse or eat well the day p/vax until 8hr IV fluids
After his shot about 2.5 hours he noted significant fatigue, arm felt like "i was slugged by a baseball super sore', allergies flared up, fever on/off then "shortness of breath was terrible".  "Going to the refrigerator was to the point I was getting lightheaded forcing myself to breath."  Primatene mist used for mowing grass. He bought more to use.  Today his lungs are ok (9/20/21). Yesterday he used the primatene within the first hour of waking.  Fatigue today is fine and has worn off as of 3 days ago. Started Flovent on 9/20/21 with albuterol prn, zyrtec daily with follow up in one week to recheck lung function and shortness of breath on exertion.
This spontaneous case received, initially received from the other health professional (nurse) on 07-Nov-2018, concerns a 46-year-old, adult, male patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 252227, expiry date: 31-May-2019, route of administration: intramuscular and anatomical location: left deltoid) which underwent temperature excursion. The patient did not experience any adverse reactions after the vaccination. The reporter assessed this case as non-serious. This case (201805334) was cross-linked to case 201805327 due to same reporter. Follow-up report received from other health profession on 28-Nov-2018: The patient's age (46-year-old) was added. The route of administration (intramuscular) and anatomical location (left deltoid) of suspect vaccine were added in the product tab. The reporter confirmed that, the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
Approximately two months after receiving the 2nd Moderna dose, I experienced lymphedema in my left armpit and side of left breast. Side effects included pain and numbness/weakness in my left arm, down to my left fingers. A milder version of the same lymphedema is also present in the right armpit and side of right breast, which appeared three months after receiving a Moderna booster in the right arm in December 2021. While the lymphedema is still present, the pain and swelling are gradually disappearing. The only occurrence that the swelling/pain has reappeared was during recovery from the Moderna booster. In this instance, though the Moderna injection occurred in the right arm, both arms swelled.
PHN gave Tdap instead of Dtap. see attached MICR and Immz. flow sheet. Dr Notified by phone at 1615. 11/14 TC from Dr's office Re what vaccine given on 11/14/07; 11/15/07 PHN called Dr's office - child seen PA Temp of 101 deg; throwing up for 12 hours (7p to 7Am) on 11/13/07 fussy. getting Oral Tylenlol
has noticed swelling, redness, and itchiness at the vaccination site/my injection site is little puffy and red and itchy; has noticed swelling, redness, and itchiness at the vaccination site/my injection site is little puffy and red and itchy/Little itchy on injection site and it is turning red; has noticed swelling, redness, and itchiness at the vaccination site/my injection site is little puffy and red and itchy/Little itchy on injection site and it is turning red; This is a spontaneous report from a contactable consumer (Patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. Medical history reported as none. There were no concomitant medications. The patient had taken the vaccine last 23Dec2020 and had noticed swelling, redness, and itchiness at the vaccination site today on 26Dec2020. It was a little itchy on injection site and it is turning red and her injection site was little puffy and red and itchy. She was asking if this is normal. No treatment received for the events. The outcome of the events was unknown.
Later that evening developed stridor that was not relieved w/ steam/cool air. Mom took to ER where he received racemic epinephrine & oral DECADRON.
Breakthrough case admission after 3 vaccines  Pfizer 2/3/21 lot# EM9810;  Pfizer 2/23/21 lot# EN6202;  Pfizer 10/22/21 NO LOT #
The pt experienced vasculitis at the left leg around injection site for 2-3 days. Treated with Benadryl.
PSORIASIS FLARE UP/PSORIASIS HAD BEEN VERY BAD AND SHEDDING; FATIGUE; This spontaneous report received from a patient concerned a 40 year old male. 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, intramuscular, batch number was not reported) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced psoriasis flare up/psoriasis had been very bad and shedding, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and had not recovered from psoriasis flare up/psoriasis had been very bad and shedding. This report was non-serious.
Patient reports being Covid + on 10/13/2021. Patient received Pfizer vaccine with 1st dose on 03/05/2021 and 2nd dose on 03/26/2021.  Per ED Note: 62-year-old male presents to the emergency department with shortness of breath, body aches, and headache.  He states that he tested positive for Covid infection on Wednesday.  He also complains of fevers and chills.  He denies any associated chest pain.  He denies any lower extremity pain or swelling.  He denies history of DVT/PE.  He does state that he is a liver and kidney transplant patient.  He does state that he received both Pfizer vaccine doses  62-year-old male presents to the emergency department with fever, shortness of breath, body aches, headache, and COVID-19 infection.  The patient was found to be hypoxic on room air at 86%.  He was placed on 2 L supplemental oxygen which improved his saturation into the upper 90s.  A chest x-ray and laboratory analyses were ordered for further evaluation.   The patient's chest x-ray revealed bilateral infiltrates consistent with Covid pneumonia.  His laboratory analyses revealed a lymphopenia in addition to hypomagnesemia.  His magnesium was replaced with 2 g of IV magnesium sulfate.  His BUN and creatinine were also slightly elevated consistent with dehydration.   The patient will be admitted to the internal medicine service with infectious disease on consultation.
This spontaneous report as received from a license vocational nurse refers to a patient of unknown age and gender. Patient's medical history, concurrent conditions and concomitant therapy were not reported. On 17-AUG-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot number reported as K008821, Expiry date: 19-JUN-2016) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.