chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles outbreak; This case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt date: 25-JAN-2023 Reporter comment: The GSK sales representative called the response center to report that a physician had informed her of an adverse event with Shingrix. The patient received 1st dose of shingrix and later developed Shingles. The reporter consented to follow up.
hives; This is a spontaneous report from a contactable nurse. A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 03Aug2021 (Lot Number: EW0179) as dose 1, single for COVID-19 immunization. The patient's medical and concomitant medications were not reported. The patient broke out in hives on 03Aug2021. The patient took Benadryl which resolved the hives and at the time of report, she was better and not having any symptoms. The pharmacist then asked recommendation for the second vaccine. Outcome of the event was recovered on 04Aug2021.
Pt's mother first noticed on 03/14/2002pm while putting child in tub, swollen, painful and red right deltoid. Next day on 03/15 rash started on neck and across top of shoulder. Seen the physician on 03/15 and diagnosed as skin infection. Keflex po x 14 days. Child denies any pain on 03/15.
Chest pressure/tightness starting approximately 24h after the vaccine. No allergic reaction or sign of anaphylaxis. No shortness of breath or trouble breathing, just general chest tightness. Got a little better the next day, but still a bit of chest tightness. Almost feels like the type of chest pressure you get when you have a bad cold with postnasal drip.
today is the 3rd day with persistent headache, mild nauseas, sore throat, malaise and tiredness. Relieved by Acetaminophen use 1000 mg every 8 hrs
Chills from 2100-2400 5APR Elevated resting heart rate (160bpm) 2300-0700 6APR Joint pain in every joint 2300 5APR-1700 7APR Swelling and pain at injection site 5APR-9APR
This spontaneous report as received from a medical assistant refers to a patient (unknown age and gender), who on August 2011 was vaccinated with a only dose of GARDASIL (dose, route and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that the patient had not received any additional doses of GARDASIL, and there was no adverse effect had been observed or reported. At the time of the report, the patient's outcome for the adverse event was unknown. This is one of two reports from the same reporter. Additional information has been requested.
2:15 AM- body aches, headache, chills 4:30 AM- nausea, fever 101.1, bodyaches, headache   Injection site sore, red, raises until 3/15
had a reaction  the day after the vaccine and continued to feel fatigued in the days to come. Two weeks after the vaccine I started to have massive headaches mostly around midnight.  On about the third day, I woke up with double vision. I saw a neurologist and an eye doctor and at at some point I went to the ER because I was afraid of an aneurism or something like it . I had not slept well due to the pain. I mentioned to all the physicians about the vaccine but I was told there was no data to support my suspicion. The double vision got worse, after a month I saw a neuro ohtalmologist who called it 6th nerve palsey.
Case number PHEH2015US023067, is an initial spontaneous report received from a health care professional on 06 Nov 2015. This report refers to a 39-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was administered expired FLUVIRIN (batch number: 1414101) intramuscularly at a dose of 0.5 ml on 26 Oct 2015. The case was reported as non-serious. No adverse event was reported.
I received the Moderna Bivalent booster on 9/15/2022. On 12/11/2022, I developed a scratchy throat, a slight cough, and post-nasal drip during the afternoon. On 12/12/2022, I still felt like I was developing a mild cold, so I just stayed at home and did not go out. I took ROBITUSSIN DM cough medicine and SUDAFED, which provided a little bit of relief. When I woke up on 12/13/2022, I had a very runny nose. It was then that I decided to take a home antigen test, which yielded a positive result. I then called my doctor, who prescribed me PAXLOVID. On 12/15/2022, I felt really good and like I had recovered, and I wanted to go out and go shopping, but I took another test that yielded another positive result, so the shopping trip was nixed. At the time of this writing, I feel like the symptoms I thought I had beaten are back. I currently have a scratchy throat, a slight cough, and post-nasal drip. During my illness, though, I have never experienced a fever.
CHILLS AT NIGHT; HEADACHE; TEMPERATURE OF 101.1 F; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced chills at night. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced temperature of 101.1 f. Laboratory data included: Body temperature (NR: not provided) 101.1 F, 100.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, chills at night, and temperature of 101.1 f. This report was non-serious.
Patient had received vaccine. While vaccinating mom, daughter said she wasn't feeling well. Vaccinating tech went to go grab water and patient passed out became very stiff and stopped breathing for 30 - 45 seconds. blood pressure was very low. gave patient water. ems came evaluated pt. pt was nauseated when she left otherwise was talking and breathing appropriately.
Immediate dizziness. Malaise within about four hours. Flu-like symptoms within about 8 hours - headache, general muscle ache. (This responded well to Advil.) General malaise, slight depression and tiredness for at least one week following the vaccination. (I'm submitting this report because when I saw a recent list of side effects, depression was not included. But not only did I experience it, but I've heard from others that they have as well.)
***VACCINE ERROR ***  Patient came in with his daughter for a booster dose of Pfizer. All registration had been completed by the patient prior to arrival and the patient was requesting a Pfizer booster dose. Patients daughter and father verbally confirmed that the previous two doses were Pfizer vaccine to the receptionist and pharmacist. Pt did not provide CDC card.  Pt and pt?s daughter dishonestly provided inaccurate information pertaining to the patients vaccine history on multiple occasions to numerous staff members. Upon receiving the Pfizer vaccine pt?s daughter admitted to deceiving staff so that her father would get the Pfizer.  Pt did not have any adverse reactions, he waited 15 minutes and left.   Staff immediately reached out to the CDC to get a response in regards to follow up or adverse effects. CDC advised there was no need for any follow ups and that there are no potential adverse effects of mixing vaccines.
This spontaneous report as received from a nurse refers to an unknown patient of unknown age and gender. On an unspecified date between 16-JUL-2013 and 25-JUl-2013 the patient received an unspecified single dose of improperly stored GARDASIL, injection (lot number 1291AA, exp. date 12-APR-2014, route not reported) at an unspecified off site clinic. The reporter stated that GARDASIL has been exposed to total time out of range a maximum of 60.5 hours of minus 2 Celsius degree. No adverse effects were reported. The outcome of events was unknown. This is one of 4 reports from the same source (MARRS#1308USA002370; 1308USA003562; 1308USA003561; 1308USA003560). Additional information has been requested.
I tested positive for COVID-19 on 1/27/23. I had a sore throat, cough, congestion, and fatigue. I contacted my doctor and was prescribed 5 days' worth of PAXLOVID. I finally tested negative 2/4/23, then I started having symptoms again and tested positive on 2/10/23. I am still dealing with these symptoms at this time.
I had burning and redness on my right upper thigh on the home. I have small fiber neuropathy and it flared that up by I would say day 4-5. With it came some new symptoms. I felt the small finger joints in my hands were being crushed by plyers. Weirdly, I didn't get all my normal chorus of small fiber neuropathy symptoms. The symptoms entirely resolved before the 2nd shot.  After the 2nd shot I had 7 months of neuropathy. I had flooding this time. I am post-menopausal, so that was very strange. My right leg burned so intensely that it felt like I was getting  an active carpet burn. I had a repeat of the new finger symptoms again.  I had the normal burning, vibrating, numbness, stabbing pains, and so forth that I get with the small fiber neuropathy but I didn't experience facial numbness. I normally experience neuropathy primarily in my legs and feet (and part of my face goes numb) but after the vaccinations I have been experiencing neuropathy in my hands and lower arms. This all resolved until 3 days ago. I am now experiencing a flare up in my hands. This time with a new symptom. The top of my right hand hurts to touch. The top of my right forearm is burning has bone pain (as does my hand). The bones in both hands in the small finger joints feel like they are being crushed.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 25-AUG-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 (strength, dose, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. No adverse effects were noted. The outcome of the event was unknown. Additional information has been requested.
Pt reports redness and swelling of entire right arm on 10/15. Pt went to local ED for evaluation and treatment. Pt reports redness "followed the lymph nodes of the right arm up to shoulder and neck area". Pt treated with IV abx and was prescribed oral abx upon discharge of visit.
Headaches, fever, chills, lethargy,  body aches for 10 days and STILL COUNTING.   I also got blisters on the insides of my lips in my mouth. And the sad part is that after ten days I am STILL dealing with these relentless reactions.
Pt stated when right into an auto immune response, was seen in the ER with severe headache, mouth sores and extreme body soreness.  Patient Celiac disease is on multiply medications and under drs care.
Nauseated with body aches, severe headache, and dizziness - duration 48hrs.
11 days after I received the shot - I had swelling on my face in the areas where I got Juverderm injections.   The swelling lasted for about 24 hours - I took benadryl and it seemed to help.    I wasn't sure if it was the vaccine.   Please advise.
HYPERVENTILATING; FEELING LOOPY; DIZZINESS; COULDN'T WALK STRAIGHT; COULDN'T MAINTAIN BALANCE; STATE OF CONFUSION; TROUBLE BREATHING; SLURRING WORDS; BED RIDDEN; This spontaneous report received from a consumer concerned a male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced bed ridden. On 28-MAR-2021, the subject experienced hyperventilating. On 28-MAR-2021, the subject experienced feeling loopy. On 28-MAR-2021, the subject experienced dizziness. On 28-MAR-2021, the subject experienced couldn't walk straight. On 28-MAR-2021, the subject experienced couldn't maintain balance. On 28-MAR-2021, the subject experienced state of confusion. On 28-MAR-2021, the subject experienced trouble breathing. On 28-MAR-2021, the subject experienced slurring words. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bed ridden, feeling loopy, dizziness, couldn't walk straight, couldn't maintain balance, state of confusion, trouble breathing, hyperventilating and slurring words was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard operating procedure as the case assessed as non-serious.
This spontaneous report as received from a medical assistant and refers to 24 unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored LIQUID PEDVAXHIB which had a lot  # M027883 and an expiration date of 15-APR-2019; however, dosage number and route of administration were not reported), for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 5 minutes: 9 grades centigrade. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of several reports received from the same source.  Additional information has been requested.; Sender's Comments: US-009507513-1701USA006026: US-009507513-1701USA014268:
Patient left the facility and went to eat at a neighboring restaurant where she lost ability to communicate, became flush, and EMS was called. When we followed up with the patient that same evening, patient states she was treated for dehydration and released from the hospital after receiving IV fluids.
left kidney infarcted; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 26Aug2021 (Lot Number: FC3184) as dose 2, single for COVID-19 immunization.  Medical history included COVID-19 on an unknown date prior to vaccination. The patient had no known allergies. Concomitant medications included zinc (manufacturer unknown); vitamin c (manufacturer unknown) and vitamin d (manufacturer unknown) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccines in 4 weeks. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) on 02Aug2021 (lot number: FA7485) in the left arm for COVID-19 immunization. The patient was not tested for COVID post vaccination. On 01Sep2021, the patient's left kidney infarcted. The patient spent two days in the hospital from 01Sep2021 to 02Sep2021 and was readmitted on 08Sep2021 to 14Sep2021 as the affected kidney area expanded to damage more of his kidney. The event resulted in an emergency room visit, hospitalization and disability/permanent damage. The patient was hospitalized for a total of 9 days. The patient received heparin, Lovenox and coumadin as treatment for the event. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
This was my first booster shot and was a Pfizer COVID vaccine booster. My original series was Moderna with no reaction. Within 10 minutes, I had extreme vertigo and asked my husband to drive me home. For the next 48 hours I had severe vertigo and vomiting. I remained on the bathroom floor for those 2 days. Once I stopped vomiting, I had random bouts of vertigo for an additional 8 days.  During the first 5 days, I also began urinating dark brown bloody urine but with no other urinary symptoms or pain. After 5 days, this resolved entirely.  Following these 10 days of reaction, no further reaction happened.
Serum sickness syndrome, fever not greater than 101, severe muscle and body aches/pains, nasal congestion, extreme fatigue, cough, nausea, loss of appetite First vaccination in 55 years
Patient received 3 vaccines while sitting on the exam table after 5 minutes patient was walked to the lab waiting area to wait the rest of her time there. While walking patient began to wobble and her color became pale. I held the patient and walked her back to the room, Dr. assisted patient then lost consciousness once we reach the room.   No reaction at the injection site but patient did lose consciousness. Vitals taken, Physicians informed. Elevation, ice pack, ammonia cap done, oxygen given,  Ambulance called and patient transported to  Hospital. Patient did not regain consciousness.
After receiving shot, patient fainted for about one minute and then vomited. Paramedics came and cleared him, patient left on his own, walked out.
Seriousness criteria other medically significant (OMIC). Initial report received on 10/17/06 from a health care professional. A 34 year old female pt, with a history of latex allergy, had received an IM injection of Fluzone SV 2006-2007, lot number U2165CA, on 10/17/06. Ten minutes post vaccination, the pt experienced lightheadedness and shortness of breath. She was treated with IV Benadryl and transported to the ER. At the time of this report, the pt had not recovered.
Developed hives beginning at 3pm on 9/3/03 JE booster given 9:20 am on 9/20/03 started on palms of hands and spread quickly to arm then neck and face then trunk and lower legs. Took 50mg Benadryl and within 1 hr symptoms began subsiding. Pt advised for any worsening of sx's-to go directly to ER. If develops shortness of breath-throat scratchy, severe rhinitis-worsening hives to go to ER immediately.
Starting around 11 am the next day (4/10) after receiving the vaccine, pt. states noticed left upper arm pain, redness, bruising and warm to touch.  Pt. states also started 'feeling bad' and complained of nausea, body aches, fever, chills and headache. Pt. called to report symptoms to nurse on 4/13 - states was feeling better but that her arm was still red and warm to touch.
Patient experienced tingling in lips and end of fingertips, bad taste in mouth, no appetite except bread
low grade fever; Pain at injection site; Flu vaccine received at same time in opposing arm Comirnaty Bivalent formulation received.; Flu vaccine received at same time in opposing arm Comirnaty Bivalent formulation received.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown), in arm. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 , MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 3, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "low grade fever"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain at injection site"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "Flu vaccine received at same time in opposing arm Comirnaty Bivalent formulation received.". Therapeutic measures were taken as a result of pyrexia.  Additional information: Flu vaccine received at same time in opposing arm Bivalent formulation received. It was the 4th dose, approximately 1 year after the 3rd dose. Fever managed by Tylenol. Event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
4 month old patient was given HPV quadrivalent vaccine.  No adverse reaction noted.  Contacted CDC and advised by MD that there is no expectation to see more than a normal local reaction to injection.
Six days after the vaccination,  site developed a large red circle. Very  itchy. Seventh day still red, itchy.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 18:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Overweight (BMI around 28)" (unspecified if ongoing); "BMI around 28" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: first time testing since originally testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: product was COVID 19 Treatment, brand=Paxlovid, treatment start date at 29Jan2023, treatment stop date at 02Feb2023. other medication in 2 weeks: Yes. Known allergies: No.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pfizer 12+ vaccine given on 5/25/22 and patient was only 11 years old on date of vaccination.  No report of any symptoms or concerns as of 6/21/22.
After I got the booster, 11/23/2021- I got a rash all over my chest, that evening. It got worse when I got symptomatic with COVID-19 and it just cleared up in the last week. I got a rash after my 1st Moderna vaccine on my back. On 11/27/2021-I thought I pulled a muscle in my back, I was having back pain. I had fever, headache, no taste and smell. It all stayed in my head though, it did not go into my chest. On 11/29/2021-At the Hospital -I tested positive for COVID-19 and I received the monoclonal antibodies on that same day. They also gave me a dexamethasone injection and a Zofran. And I had some prescription cough medicine. I am recovered. I still have some of my fatigue and my taste isn't right. Note: I did receive the flu vaccine sometime in October, but I don't remember when.