chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. A number of months ago, I attended a function to support the troops. I went there because I felt a duty to present information on what I consider a national tragedy - the forced use of the Anthrax vaccine. At the event, I met a fine young man. He was walking with a cane, and although he attempted to be in positive spirits, you could see he was fatigued and racked with pain. During our time there, he had to lie down, paramedics were summoned and oxygen was administered. He is in his 20s and was in good health prior to receiving his required Anthrax vaccine. Before and since the meeting, I have personally talked with dozens of people who have been negatively affected by this vaccine. They are afflicted with a wide range of conditions - burning sensations, fatigue, diminished ability to think clearly, and many other problems. More often than not, they have been dismissed out of hand and sometimes told to see a psychiatrist and then diagnosed with depression. One fine lady, who I was privileged to meet, was discharged from the military after refusing her fifth shot. She greatly feared the problems she would encounter in her fifth shot because of the massive health problems she experienced from her fourth Anthrax shot. (OMIC)
Patient received #2 GARDASIL on 5-12-09 and called 5-15-2009 reporting c/o itching / have several hours after she had GARDASIL 5-12-09. Pt took Benadryl as suggested by pharmacist per Pt. (gel + tab Benadryl Pt received relief injection site itchy on 5-14-09. Also some nausea + throat got dry on 5-12-09 per pt.
On March 9, developed significant palpitations. These recurred every day and on March 15 I went to ED. No MI detected but Holter monitor for next 2 days shower 600 PACs per day. Started Flecainide, which helped. Breast MRI in April showed large pericardial effusion behind left atrium. Took medication until July 1st. Palpitations resolved.
26 y.o. female with a copper IUD who received second dose of Pfizer vaccine. Developed vomiting, myalgia, and fever next day. These symptoms resolved but then developed pink colored hematuria two days post vaccine, and was seen in clinic that day. Urine sample collected with 4-10 RBCs and moderate amount of blood found from lab. Last menses two weeks ago. She did have similar issues years ago, but past lab results were not available. Was referred to urology.
administered Quadracel that expired 08/21/2019 to a patient, no AE; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 years old female patient who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot: C5248AA expiry date: 21-Aug-2019) via intramuscular route in the arm NOS on 12-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was an actual medication error due to expired vaccine used.  At the time of reporting the no adverse event was reported.  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.
aches; fever; chills; This is a spontaneous report from a contactable consumer (Pfizer colleague). A male patient of an unspecified age received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter reported for a patient who had some side effects following receiving the second dose of the COVID vaccine. The patient experienced aches, fever, and chills on an unspecified date. The patient was aware that "the second shot in the series can be kind of bad." The outcome of the events was unknown.   Information about lot/batch number has been requested.
This spontaneous case was reported by a nurse and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (She thinks this triggered an immune response that helped with inflammation she had), UNDERDOSE (She then had the vaccine where she got the half dose booster) and PYREXIA (fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 025B21A and 045B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Fibromyalgia and Cervical spine degeneration. Concomitant products included DULOXETINE, PREGABALIN (LYRICA), AMFETAMINE SULFATE (AMPHETAMINE SALTS), ATENOLOL, FLUTICASONE and CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021 at 10:50 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, the patient experienced UNDERDOSE (She then had the vaccine where she got the half dose booster). On 14-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (She thinks this triggered an immune response that helped with inflammation she had). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (She thinks this triggered an immune response that helped with inflammation she had) and UNDERDOSE (She then had the vaccine where she got the half dose booster) outcome was unknown and PYREXIA (fever) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received half dose booster of Moderna COVID-19 vaccine. She drank a lot of water and the next day she got a fever and she woke up in the middle of the night to take Tylenol. She went back to sleep and she woke up feeling better. Her neck felt better than she had since Sep-2021. She thinks this triggered an immune response that helped with inflammation she had.  Patient had comorbidities that that were diagnosed years prior receiving any Moderna COVID-19 vaccination (about 8 years prior   This case was linked to MOD-2021-418615 (Patient Link).
I started feeling very itchy 12/18 after 11 pm. By 12/20 I went to an urgent care facility because I had a rash everywhere, I was super itchy, my hands and feet were swelling and it hurt to put any pressure on them. They said I had hives and prescribed 8 milligrams of Dexamethasone for 4 days. It lowered the hives substantially, but when I ran out, everything came back. I requested a refill and took it until 12/25. I did not take it on 12/26, and by 12/27 at 3 am I went to the ER because the hives were everywhere and my face and neck were swelling up. They prescribed 20 milligrams of Prednisone for 3 days. It lowered the hives and swelling substantially. I set up an appointment with an allergy specialist 12/29.  At that time, I had taken my last dose of Prednisone and my hives flared up as the allergist examined me and she saw how bad it was even with medicine in my system.  I am now on: 1. 5 mg of Levocetirizine Dihydrochloride a day 2. 10 mg of Montelukast sodium a day 3. 80 mg of Famotidine a day 4. 40 mg of Cetirizine Hydrochloride a day
Fever, myalgias, headache, chills; injection site with splotchy red, warm, indurated skin.
Tingling in left forearm down to palm, onset 1 hr after administration of flu vaccine.  Bruising noted at injection site
This spontaneous report as received from a physician via a company representative refers to an adult male patient of unknown age. Information on patient's pertinent medical history and concurrent condition was not reported.  On an unspecified date in December 2016 (reported as this past week), the patient was vaccinated with properly stored ZOSTAVAX (dose, route and lot number not specified) and later it was discovered that the patient had received a dose of properly stored ZOSTAVAX (lot number and expiration date not reported) approximately sixteen months ago (unspecified date in September 2015). No adverse effect was reported. No additional information was available. Additional information has been requested.
Received vaccine @ 10:12 am - arrived @ 10:37 a.m. redness/tenderness @ injection site. Iced/observed x 10 min. Ice off x 10 min. No change. Called mom. Gave 12.5mg BENADRYL.
Severe muscle aches and fatigue, chills, night sweats, hypersensitivity of skin (prickly sensation0
Redness, swelling, itch, and soreness of left arm from shoulder to elbow starting the evening after receiving the SHINGRIX vaccine.
that look like hives; red pimples and hives like thing; On her stomach; little red lumps over her body or belly/red pimples/On her stomach; It looks like shingles; This is a spontaneous report from a contactable consumer or other non hcp (patient's husband). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6206), via an unspecified route of administration on 15Mar2021 as dose 2, single for covid-19 immunization (vaccinated at 68 years of age). The patient medical history and concomitant medications were not reported. The patient experienced that look like hives; red pimples and hives like thing; on her stomach, little red lumps over her body or belly/red pimples/on her stomach, it looks like shingles on an unspecified date in Mar2021. Reporter's wife got the second dose on 15Mar2021. About 1 week later, she got hives on her stomach. Reporter asked if it was a side effect of the vaccine. Reporter stated, his wife and he, they got the second dose of Pfizer Covid vaccine last week and his wife yesterday started to break out it was not hives but they were little red lumps over her body or belly. She had gone to the doctor but the doctor didn't know, the doctor didn't have experience with Pfizer vaccine and what he want to find was, was that a side effect that had been reported. Reporter stated, it was just basically around the belly, around the thigh. It looks like shingles, but the doctor said it wasn't shingles, but he didn't know what it was. The Pfizer thing was new, and the side effect was new so he don't know. Reporter stated, he doesn't know what her body weight was. Reporter stated, the doctor gave her some cream to put on the red spots, the things have popped up. Therapeutic measures were taken as a result of events which includes cream. The outcome for all events was unknown.   No follow-up attempts are needed, Information on lot/batch number cannot be obtained.
after getting the "first round of M-M-R II vaccine required by his school," she noticed post vaccination that her son developed a "respiratory tract infection"; The patient developed "persistent cough."; This spontaneous report has been received from a consumer, who was the patient's mother, referring to a male patient of unknown age. Information about the patient's pertinent medical history included a pre-existing condition such as sleep apnea. His concomitant medication and previous drug reactions or allergies were not provided by the reporter.  On an unspecified date, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) required by his school for prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not provided by the reporter).  Subsequently, the reporter noticed that the patient developed a respiratory tract infection and a persistent cough.  It was unknown if any treatment was given for the events, if any laboratory diagnostics/studies were performed or if the patient sought medical attention.  At the time of reporting, the outcome of the aforementioned events was not provided.  The causality assessment between therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the reported events was not provided.  Upon internal review, respiratory tract infection was determined to be a medically significant event.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA000655:
no symptoms in office-mom called on 5/3/2023 to report to our office baby was fine and having normal daily bowel movements through April 25, 2023 which is when he received his 2 month vaccines, she states on April 26, 2023 he began with very bad gas and fussiness with this gas, he has had episodes of spitting up, he is fine in between these spells, no reports were made to our clinic until 5/3/2023 and mom feels his symptoms are a reaction from the vaccines, we have explained to mom also that the age 1 month - 3 month could be a time to develop colic as well, offered mom to come in to bring baby to be seen by Dr., she asked for walk in times and was given those, advised mom she could bring him in as a walk in or we could put him on the schedule at a time that may suit her best, no apts. were made before mom hung the phone up
Shot given around 2PM, no rxn until 9PM same evening; Child began to scream & shake turned pale, eyes rolled back looked lifeless, looked almost unconcious several hrs p/this;
pt recv vax 18NOV96 & 4 to 5 hr post vax pt devel an inc in hearing loss & a humming type of sound;in infect reported;9DEC96 audiogram revealed sl downward shift @ 250 cycles per second;pt is a diabetic taking micronase;
Tingling in throat & cough for approximately 2 hours post vaccine. Resolved without medical therapy.
Fever Fatigue Narrative: Stayed home from work on 1/21 due to fever and fatigue. Afebrile overnight and has returned to work.
Reports began as small nodule LUE, grew in size and became indurated and itchy. Spread in size next day. Slight erythema, itching.  Gradual decrease on day 2.
9/10/07 Extreme pain - slight swelling ate site. 9/11/07 Pain, swelling, site very hot. 9/12/07 Pain less but swelling more severe with itchiness. Swollen site about 2 inches.  9/15/07 Itchiness and swelling subsiding.
Parent reports L arm red, swollen, warm to the touch, redness from left shoulder down to patient's bicep. Patient is able to move his arm but complains of pain upon movement. Patient never presented with a fever, parent stated, "his arm was so swollen the bandaid was like embedded in his arm."  Parent reports she did give patient fever reducer for the pain and swelling but did not seem to help, PHN encouraged parent to go to ER or to PCP for follow-up care. Parent said she would go  to PCP with patient later today.
Patient experienced itchy palm and lightheadedness. She was treated with 25mg of Benedryl and observed for 30 minutes during which time symptoms resolved.
Involuntary muscle jerking of her neck; happened repeatedly on the right side.  This occurred on the 22 and 23. By March 24, her reaction was more standard (cranky, less like herself).  No treatment given.  Didn't know quite what to do but watch her.
Information has been received from a emergency medical technician and a patient's mother concerning an 18 year old female with KEFLEX allergy who on 24-SEP-2007 (previously reported as "6 months ago") was vaccinated with the first dose of GARDASIL (lot# 658558/1061U). On 13-FEB-2008, she was vaccinated with a second dose of GARDASIL (lot # 659439/1267U). On 19-AUG-2008 (previously reported as "week of 11-AUG-2008") the patient was vaccinated with a third dose of GARDASIL (lot #660612/0229X), 0.5, I.M. Shortly, after receiving her third dose, on 19-AUG-2008, the patient experienced a 30 mm nodule at the injection site (previously reported as a lump at the injection site, the size of a "half dollar"). The patient sought medical attention calling the practice. The nodule persisted for 7-10 days, then resolved. The nodule returned at the same area in September 2008. At the time of reporting, the patient had not recovered from the nodule at the injection site. Additional information has been requested.
March 5 - Difficulty walking, pain in leg, used a cane. March 6-Right leg and knee pain worse so I wore ACL brace from 1998 all day at home.After taking off the brace I noticed rash on my knee and above my knee on left side.  More splotches appeared March 7 and began to itch. March 8 at 8AM went to urgent care and prescribed Acyclovir for 10 days:1 tablet 800 mg to help with nerve pain in right leg.
Patient reported when we contacted her  today 08/05/2019 about getting her second dose. She stated a few days after receiving the first dose she had numbing in her arm. She says it has continued to present however the symptoms have lessoned over time. She reported this to her primary prescriber. She was told by the primary prescriber to report to FDA but she did not. She also said the prescriber said she could get the second dose if the patient wanted to get it.
She did not get her period she may be PG (she has not tested yet); This is a spontaneous report from a Pfizer sponsored program . A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Mar2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, received first covax on 24Mar. She did not get her period she may be PG (she has not tested yet) and is asking if there is any information on pregnancy . The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Could have begun previous night, we noticed when he woke 2 hours early 9/10/16.  He is experiencing lethargy and "green" look to skin tone.  Biggest issue is that site (leg) appears to be very stiff and sore.  He is limping and seems unable to bend the leg.  More stiff than sore.  Better word for limping probably, because it is that he is keeping the stiff leg completely straight while walking.  Administered ibuprofen. Still experiencing symptoms so appropriate event outcomes can't be checked at this time.
That night, headaches and chills really bad. By that evening, around 6, I couldn't get off the couch by myself. I got up and it felt like my ribs were rubbing against my kidneys. It was hurting that bad. I felt like I did when I had COVID the first time.  I just laid on the couch. I took 2 Ibuprofen that helped more than Tylenol. My lymph nodes were swollen and I couldn't even put my bra on. The swelling was also in my neck. I continued to have chills and a fever. I was sweaty. From Friday to Sunday, it started to dissipate and then I was able to get around better. My lymph nodes were swollen for about 5 days.  I started to feel better, with the exception of my arm which is still bothering me. I experienced sharp pains in my arm last night and it's been itchy.
Per the clinical lead Hepatitis B and HPV vaccine trasported to clinic in Brown portable cooler. A vaccine excursion occurred with the brown portable cooler. The temperature on the brown portable cooler went out of range based on Engerix- B and Gardasil manufacturer recommendations. The portable cooler reconditioned and Hepatitis B and HPV vaccine admistered to patient. Manufacturer conatcted by representative. Per the Health Department they were advised by GlaxoSmithKline and Merck Sharp & D that the Hepatitis B and Gardsil vaccine was not viable and the patient needed to be revaccinated.
Patient moved before receiving the injection (Moderna batch/lot# AS1414B). The needle came out and changed. With mom's help in securing the patient properly, he received the vaccine successfully in the other (right) arm.
1st dose of moderna on1/7/2020. Low fever and muscle aches started 2-3 days after shot, getting worse from 4-5th days. Contact doctor and Dr ordered the covid test on 1/14, and the test is negative. Low fever ( mainly in the afternoon) and muscle ache continue with fatigue until today 1/21/2020.  Ibuprofen 200-400mg or tynenol 500mg given.
A rectangle of reddened area approximately 3.5inces by 2 inches around the vaccination injection site. Does not itch, not painful,
This is a spontaneous report from a physician via Pfizer Sales Representative. A patient of unknown age and gender received PREVNAR 13 in Jul2014 at single dose. Relevant medical history and concomitant medications were unknown. After vaccination, on an unknown date in Jul2014, the patient had immediate redness and swelling at the injection site and developed cellulitis. Relevant laboratory data was unknown. Therapeutic measure taken in response to the reported events was not provided. Clinical outcome of the reported events was unknown at the time of report. Physician mentioned that the adverse events were due to PREVNAR 13.
2.5cm x 3cm erythematous slightly edematous skin nodule of left anterior thigh; tender to touch
Bruising at site, arm soreness, swelling, redness.  Body aches, neck pain/tenderness, fatigue. Also hair follicle tenderness on scalp.
This spontaneous report as received from a licensed vocational nurse refers to unspecified number of patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored ROTATEQ, orally, with either lot number L048854 with expiration date of 31-AUG-2017 or M002254 with expiration date of 15-NOV-2017 or L033693 with expiration date of 31-MAY-2017 (strength and dose were not reported), which was stored at 1.1 celsius degrees for 24 hours. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
No adverse events, was an error in dilution, so the patient received more dose. They administer 0.2ml of the vial, without dilution