chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she contracted eye herpes; shingles; This is a spontaneous report from a contactable consumer or other non hcp (parent). A 14-year-old female patient received first dose of BNT162B2 (BNT162B2, Solution for injection) via an unspecified route of administered in left arm on an unspecified date (Batch/Lot number was not reported) on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD) and Raynaud's phenomenon. The family history included autoimmune disorder (autoimmune runs in our family). The concomitant medication included methylphenidate (DAYTRANA) patch, paroxetine and methylphenidate hydrochloride (RITALIN); all were received started on unspecified date and indication. On an unspecified date, she contracted eye herpes, treated it like it was pink eye and then it got worse and shingles. The reporter stated, "they thought it was a bacterial pink eye and we went to instant care and it didn't get any better and so we went to ophthalmologist who diagnosed her with herpes eye and that is like shingles, it is like chickenpox shingles within same family". So, they said, it was herpes eye and I read on the internet that there are mostly women who get this but there were couple of cases of women who have autoimmune that get shingles or herpes or some adverse effect like my daughter got that and ran in to the eye. Reporter further stated, "because I am concerned because that is what happened to my daughter. I don't know if I should get the shingle shots, I mean she is 14, you wouldn't take the shingles shot but now it is too late, she already has it, so that is why I am little bit concerned. But I just wanted to report this because children may not be formally diagnosed with autoimmune. I know she had some symptoms, I don't know if it is related, I don't, I have no idea but it is just weird that she got the herpes eye. Therapeutic measures were taken as a result of the event with vala like clover 500 mg for herpes for 2 months. The outcome of the events was reported as not recovered.  Information about lot/batch number is requested.
About 6 hours after my daughter was born she stopped breathing as we were going to bed (miraculously as our nurse was holding her and checking on her one last time otherwise she could have died and we wouldn't have known until morning). She was rushed to the nursery where the nurses had to provide heavy stimulation to get her to breathe again. She was then assessed and eventually transferred to the NICU for testing for the next 7 days. Her doctors initially thought she may have an infection so they put her on broad spectrum antibiotics for 48 hours and ran some blood tests, which all came back normal. After a couple days of further testing, her doctors discovered that her continued apneic episodes (about 1-2 per night) were caused by seizures. They put her on phenobarbital immediately which stopped the seizures and then worked on getting her healthy enough to send her home with us on oxygen. After months of research, I truly believe my daughter suffered a vaccine injury/reaction to the Hepatitis B vaccine. Seizures and apnea are listed on the manufacturer package insert as possible adverse events and her doctors and neurologist (who we saw as an outpatient after the NICU) could not find any other possible cause. None of her doctors have suggested her symptoms could have been a vaccine reaction and those who I have discussed my findings with have disagreed with me, saying that all vaccines are proven "safe and effective," and it's not possible that they caused her seizures, but the information on the possible side effects that seem to perfectly describe what happened with my daughter is right there on the website which they continue to refer me to.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypotension-Severe, Additional Details: After about 5 minutes after getting the vaccine (@around 7:20pm), pt said she did not feel well and needed some water. Pt looked very pale. I gave her water and measure her temperature @7:20pm 94.4F, @7:25pm 94.7F, @7:30pm 95.4F, @7:45pm 96.7F. Blood pressure: @7:27pm 98/62/55, @ 7:35pm 84/61/low, and @7:42pm 114/72/66. At around 7:45pm, pt said she felt fine and was ok to leave,
Patient reported that she was fine right after the shot; then on 1/21/2021 at 3:00am she work up with chills and body aches. Hour later she was nauseated and vomited. She reports that she had joint pain of all the joints of it being 6-7 took Tylenol 1000mg for this. She developed a low grade fever of 100 being the highest. Continued to have pain and chills thorough out the day-
Received influenza vaccine at 10:30 AM on 10-06-2010, reports that around 4 hours after receiving vaccine, she became very ill having vomiting starting approximately at 2:30 PM followed by chills and diarrhea.  Reports she went to bed and slept for 15 hours straight. The next day felt very weak.  States she did not really feel good until 10-13-2010.  Reports that she did not ever take her temperature but felt like she had a fever.  Did not see a physician.
Intial lesions appeared to be blisters, then progressed to a more dissiminated rash, urgent care doctor diagnosed as erythema, later diagnosed as shingles.
Pt was given the SHINGRIX vaccine Subcutaneously 9/21/2018 when it should have been given Intramuscularly. Over the course of a few days, they reported redness and swelling at the incorrect injection site. He did not seek medical treatment as they did not deem in necessary. Symptoms have resolved by 09/26/2018.
Right arm with large erythematous area 8cm. Decreased with 2 puncture sites, non-tender-slightly warm and firm.
Rash along neck to top of collar bone (about 6 pm on 9/11/22);  Achy legs, particularly hip joints (upon waking on 9/11/22)
Brain fog; Soreness at injection site; Soreness at shoulder; Headache; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 07Apr2021 at 12:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD) and penicillin allergy. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), ethinylestradiol; norgestrel (CRYSELLE) and cetirizine hydrochloride (ZYRTEC). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, the patient experienced brain fog, soreness at injection site and shoulder, headache and tiredness. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of reported events. The clinical outcome of the events brain fog, soreness at injection site and shoulder, headache and tiredness was resolved on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Left arm with swelling, redness and itching around edges but painful in center. Area is approx size of hand.
the reporter stated that several pt devel inj site rxn characterized by redness, itching & swelling w/in 3hr of vax;
Pt reported dizziness, blurry vision 15 min after injection.  Pt laying down X 15 min. Pt stated "feeling better".
Patient developed a large bruise (size of baseball) in site of injection that has lasted >10 days.
HEADACHE; This spontaneous report received from a patient concerned an adult female. 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: Unknown) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. 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 30-SEP-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Adult onset Still's disease; symptoms started with fever; This is a spontaneous report from a contactable physician (patient). A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 20Jan2021 at 08:00 AM, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 30Dec2020 at 08:00 AM at the age of 36 years for COVID-19 immunization (left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccines were administered in four weeks. The vaccine was administered in a hospital facility. On 25Feb2021 at 05:00 PM (17:00), the patient developed adult onset Still's disease. That day, the patient's symptoms started with fever of unknown origin for 10 days. The event resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Treatment for the event included prednisone. The patient underwent COVID-19 nasal swab (PCR) test post vaccination that was negative both on 26Feb2021 and 28Feb2021. The patient was recovering from the event.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on a temporal association, a causal relationship between the event Still's disease adult onset and BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient started experiencing dizziness and fatigue with some visual disturbances. Patient stated had only eaten a power bar for breakfast and immunization given around 1 pm. Patient conditions worsen called 911 and responded the ambulance did not take the patient to the hospital the husband did later and stop by the pharmacy to inform us of her diagnosis vagus nerve reaction.
After about an hour my palpitations started and they continued for about two weeks.  My dr increased the medication I take, and they did slow the episodes down.
This spontaneous report was received from a Medical Assistant concerning to multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history or concurrent conditions were not provided. On an unknown dates the patients were vaccinated with an unspecified doses of improperly stored of GARDASIL, lot # k009202, expiration date: 17-DEC-2016 (routes, anatomical locations and doses were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had my vaccination on 10/07/2022. On 10/09/2022 I started to experience fatigue. I tested COVID-19 Positive on 10/10/2022. I fever shortness of breath and an overall sick feeling. I did start Paxlovid on 10/10/2022.
See attached documents for details. Rubella-like rash with lymphadenopathy of post auricular and posterior cervical nodes only. Some malaise and possible joint pain.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients. On an unknown dates, the patients were vaccinated with doses of LIQUID PEDVAXHIB lot # K008680, expiration date 11-MAR-2017 (dose, route and site of administration were not reported). The vaccine was improperly stored in temperature 68.2F for 2 hours. No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
After the second dose, I was sick the whole next day and I miscarried the following week.
Patient returned 20 minutes after receiving Hep A vaccine c/o hives on both arms. He was given IM BENADRYL 50 mg to txt hives F-up next day - he reported bothered by rash. Rec - he go to area clinic for treatment of rash.
Severe pain on her body; she did not complete the vaccination series; hair, joints and body were painful; inflammatory reaction to the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Severe pain on her body) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Cephalosporins Allergy), Drug allergy (Relphen Allergy), Drug allergy (Celebrex Allergy) and Autoimmune disorder (5 autoimmune disorders; no additional information provided). Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), DOXEPIN, LEVOTHYROXINE SODIUM (LEVOXYL), INSULIN GLARGINE (LANTUS), IRON, RAMIPRIL, VITAMIN D [VITAMIN D NOS], ATORVASTATIN, KRILL OIL, ACETYLSALICYLIC ACID (BABY ASPIRIN), LIDOCAINE, IBUPROFEN, CYANOCOBALAMIN (B 12), INSULIN ASPART (NOVOLOG), CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) and ARIPIPRAZOLE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN (Severe pain on her body) (seriousness criterion hospitalization) and INFLAMMATION (inflammatory reaction to the vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (she did not complete the vaccination series) and ARTHRALGIA (hair, joints and body were painful). At the time of the report, PAIN (Severe pain on her body), INFLAMMATION (inflammatory reaction to the vaccine), PRODUCT DOSE OMISSION ISSUE (she did not complete the vaccination series) and ARTHRALGIA (hair, joints and body were painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drugs reported includes Ibuprofen every 6 hours.  She was hospitalized for one day, she does not remember the date but she thinks it was 28Feb2021. At the ER the doctor gave her an injection of a narcotic pain medicine. She was discharged from hospital to take Ibuprofen. She is taking Ibuprofen every 6 hours now.  Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.   QUALITY-SAFETY EVALUATION OF PTC: BID; Sender's Comments: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.
Started with pacing and repeating a strange phrase and drooling.  Then headache and chest ache.  Followed by fever of 103 degrees.
The medication expired on 04/07/2017. Pt. has not reported any reaction.
Both hands & fingers  swollen  &  VERY PAINFUL  on   03-05-2021 -- cracked open more on fingers, than hands-  but all fingers & both hands feel like SAND PAPER--Had to use Cera/Ve Crm  and wear cotton gloves to keep "moisture in"- and I have to wear   gloves to wash anything  by hand--Have made appt. with dermatologist for 03-11-2021  to check this condition .
When reviewing forms with patient the patient disclosed a shellfish allergy. He described the symptoms of his skin turning red, shaking, and swelling in his throat as swelling in the past. He indicated that he had needed to use an epi pen in the past for his allergy.  He still wanted the vaccination and knew we had an epi pen handy.  He was given the vaccination in his left arm and was set up next to the staff development employee who was timing and monitoring patient's for symptoms. An epi pen was given to the monitor so it would be handy.  The patient's right hand started shaking within a minute and it was hard to tell if it was from being anxious.  Patient continued to communicate verbally and stated he wanted to use the epi pen.  911 was called by the staff and the staff member with the epi pen took it and the patient out of the main area. Paramedics transported him to the hospital with slight tachycardia and never did administer epi pen while in facility. Patient was always conscious and able to verbally communicate.
Rash that began on neck and spread to legs, arms, back and chest beginning 48 hours after Typhoid VI injection. Treatment, Benadryl, Zyrtec
Complained of feeling dizzy and hot approximately 5 minutes after receiving the vaccine. As he was sitting down his head threw back, he stiffened, his eyes moved left to right, and he was not responding.  The nurse and I immediately tried to lower him to the floor.  While we were doing this he partly regained consciousness as another staff member called EMS.  He was talking and answering questions when EMS arrived.  They transported him to the hospital.
This spontaneous report as received from a pharmacist refers to a patient of unkonwn age and gender. The patient's current conditions or medical history were not reported. On 03-SEP-2014, the patient was mistakenly vaccinated with an expired dose of PNEUMOVAX 23 injection (dose number and route not reported) lot number J004080, expiration date 22-AUG-2014. No adverse effects required. Additional information is not expected as the reporter did not wanted follow up contact.
I had no problem with the first shot in October.  In January, I had extreme pain, swelling, and redness for 3 days. The redness made bands across my arm from the injection site and down. By the third day, the symptoms lessened.  I considered contacting my doctor but per the information that came with the shot, I decided to wait.
after taking a flu shot twice got the flu both times; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a consumer(patient) via social media.  This case involves a patient (unknown demographics) who had flu both times (Influenza), while he received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received first and second dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had flu both times (Influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
Pt. running a temp after recent pneumococcal vaccination. CBC done and neutrophils and Eosinophils elevated. 2/23 she developed soreness, redness, and pain in her right arm at the site of the shot. She also developed a fever with highs of 103's.
Patient received Moderna booster 0.25ml which is not approved for his age 17.  No adverse effects are noted at this time.  Patient's father was notified as well as his primary care provider.
A report had been received from a pharmacist concerning a male patient. No relevant history and concomitant drug of the patient were reported. The patient had been receiving FLUMIST (intranasal) started on an unknown date. It was reported that only half the first half of dose went into first nostril and then the second half of dose went fully into second nostril which was considered as wrongful administration. Action taken with FLUMIST was not applicable. The outcome of the event wrongful administration was unknown. The report was considered to be non-serious by company physician. The reporter considered that there was no causal relationship between wrongful administration and FLUMIST.
Tetanus received one week of Moderna COVID-19 vaccine; A spontaneous report, was received from a consumer, concerning himself, a  male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Tetanus received one week of Moderna COVID-19 vaccine  The patient's medical history ,concomitant history , lab data was not provided by the reporter .  On 11 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 038A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   one week before the patient received the tetanus vaccine prior to covid 19 vaccine .   The action taken with the first dose of mRNA-1273 in response to the event was not reported.   The outcome of the event  was not reported.
Rash following BIOTHRAX vaccine.  Symptoms: Rash, pruritic, Nodule, subcutaneous.  This 19 year old PFC received her first BIOTHRAX on 04 April 2008.  Within 48 hours she experienced subjective low grade fevers, headaches (diffuse), site swelling/nodule formation "the size of an egg".  By day 4-5 symptoms had resolved but now with dry skin with red bumps to her left antecubital area, non-pruritic.  She treated with typical hydrocortisone with minimal decrease in redness or significant change in rash characteristics.  This rash lasted about 2 weeks leaving rough dry skin to areas that were red.  Anthrax #2 was given 04 May 2008 with similar symptoms developing 48 hours later.  She noted "very red, swollen bumps" to her antecubital spaces that lasted for 2 weeks resolving again to flat circles.  (Pictures were taken but have not been forwarded as of 7/10/08.)  She was evaluated by dermatology and given a non-specific diagnosis.  She advised provider though "it may be from AVA vaccine" and referred to the Vaccine Healthcare Center.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an 85 years old (also reported as 86 years old when administered vaccine) female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In January 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for prophylaxis. As a result of her receipt of zoster vaccine live (ZOSTAVAX), in March 2014, the patient suffered shingles, including any and all of its sequelae and had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions the patient requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. The patient is informed and believes and further alleges that patient will in the future be required to obtain further medical and/or hospital care, attention, and services. The outcome of the event was considered not recovered/not resolved. The event was considered related to zoster vaccine live (ZOSTAVAX).   The lawyer considered the event to be medically significant and disability.