chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Back pain 11/16 - 11/19. Shingles appeared 11/20. Valtrex presc by Dr. 11/23/09. Just had blood work all ok, not under stress, not sick.  Is there any connect or other reports of persons getting shingles from the H1N1 Flu "Injection". I understand anyone can get them that has had pocks but I find this a little suspicious with the timing of my outbreak.  Thank you.
First it was flu symptoms, I got a stomach virus and after was a sinus infection. In August I started having seizures and I had never experienced that. I have had 3 since August. The last one I had I couldn't breathe, my respiratory went low and I was given CPR. Again, all of this is new, and everything started after I got the second vaccination. I was monitored for 24 hours, at the hospital I had an EEG, but everything came back normal, My PCP referred me to a neurologist which I don't have an appointment until April unless they call me sooner on a cancellation. I have not been cleared until I see the neurologist. I hope I get some more deeper testing to find what is going on. I don't know if it's my immune system, I get sick easily now. I was healthy before all of this.
Red, raised, swollen pain at injection site starting from 24 hours post injection and still remaining 7 days post injection.
Diffuse skin rash/urticaria - given antihistamines - BENADRYL or ZYRTEC - loss of school days - about 5.
Woke up on morning of 10/6/2021 at 0645 with redness and swelling of neck, primarily left sided. Itchy and painful feeling like blistering sunburn. No new products were used, no new exposures, no history of allergic reactions. Temperature 97.3, neck warm to touch.
I received Gardisil, DTAP and a flu shot on 8/13/20. Beginning 8/14/20 I have had nausea, headache, chills, diarrhea
Within a few hours after immunizations were given, patient developed redness of upper left leg. The redness continued to spread over the next 24 hours. Then remained stable until evaluated in our office on 8/27/07. When evaluated, a 7x7 inch reaction with redness decrease raised area with a central 2" diameter knot. Tender to the touch. No inguinal adenopathy or other sxs of reaction noted.
Patient received varicella vaccine 11/20/98 and was diagnosed with chicken pox on 6/15/01.
Left arm (deltoid area) red and warm.  Prescribed Benadryl and topical antibiotical cream.  On Augmentin for Otitis Media prescribtion.  05/05/2003.
The Leur lock on the needle was not tightened and the needle detached from the syringe during administration and part of the dose was lost.
After the patient received TDAP and MENACTRA, he passed out. It took a while for him to come around. He received O2 til recovered. The patient went home 1 1/2 - 2 hrs after episode.
Chills, soreness, headache, dizziness feeling passing out on day 3. Both arms rashes and warm to touch from elbow down. Left arm more rashes than right arm.
pt recvd vax; devel inject site rxn characterized by redness & hardness;
Had small rash first appear on top of left foot  which became itchy and then approximately six hours later I developed  hives on the top of my right foot which seemed air filled.that also became itchy. I took a single Claritin and had relief within a few hours. The next day the itchiness returned and I took another single Claritin pill.  The hives went down and there was redness but the itchiness subsided.  I took a Claritin on the third day and had no other issues.  The rash and hives stayed localized only to the tops of my feet.  Important to note I did not use any different soap or detergent or have my feet exposed to any plants or vegetation.  I continued wearing cotton socks and slides as I had been doing all along.  I reported it to my doctor?s office who suggested I report it to the facility I received the shot from.  They referred me to report it here.
Patient was vaccinated with a High Dose Flu Vaccine at 1245pm . At 6pm patient had the following symptoms:Chills, Tremors, Fever, Couldn't Talk.  Patient almost had to go to the hospital. Patient felt better next day.
I have been breaking out in hives; raised red bumps; raised red bumps; Burning skin in my hands waist, groin, butt and legs; Itchy skin in my hands waist, groin, butt and  legs; sore at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2022, the patient received the 2nd dose of Shingrix. On 6th September 2022, 5 days after receiving Shingrix, the patient experienced burning sensation and pruritus. On 13th September 2022, the patient experienced hives, raised rash and red rash. In September 2022, the patient experienced injection site pain. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the hives, burning sensation, pruritus, raised rash and red rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, hives, burning sensation, pruritus, raised rash and red rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-OCT-2022 and 04-OCT-2022 Reporter's Comment: The case was reported by the patient and reported that, he received his Shingrix vaccine in the left arm.  The patient was reporting a side effect from the Shingrix vaccine.  The patient had been breaking out in hives, burning itchy skin in hands, waist, groin, butt and legs for one month almost every day since second vaccine dose. The patient wanted to be contacted by someone from GlaxoSmithKline regarding this. The reporter reported that, his left arm was sore at the injection site for about 3 days.  The patient reported that, on 6th September 2022, his hands felt extremely itchy on the tops of his hands and between his fingers.  The reporter noted that, there were no bumps or redness on his hands.  The reporter reported that, warm water seemed to resolve the itching, but that it kept coming back for a month now.  About 13th September 2022, the patient reported he had hives (raised red bumps) on the back of his legs, waist, groin and butt.  The reporter reported that, he rides his bicycle about 15 to 20 miles a day but had had to cut back due to the discomfort from the hives.  The reporter reported that, he had not gone to the doctor but had an appointment on 19th October 2022.  The patient reported that, he took 1 Benadryl capsule last night for the first time since this started in September.  The reporter would like to know if this was related to the Shingrix vaccine.
Administered dosage listed on the vial of 0.5 ml. This was a booster dose that was supposed to be 0.25ml. No adverse reaction or treatment needed.
Fatigue, body aches, fever of 103, intermittent dizziness starting 5/6 am, all of which are significantly improved today, 5/7.  By the evening of 5/6 he began having gross hematuria, which is still present.  Mild bilateral CVA tenderness on exam.
At 5:00 a.m., about 20 hours after receiving my vaccines, I was awakened from sleep by a strong hot flash and a very fast supraventricular tachycardia.  Note that I am prone to SVT due to mitral valve prolapse, but I do not normally have hot flashes in general, and do not nor do I normally have hot flashes when I have SVT.  The SVT was also faster than what I normally have.  For about 15 minutes I attempted vagal maneuvers (coughing), slow breathing and relaxation, and splashing cold water on my face, to no avail.  At that point I took 50 mg Atenolol and returned to slow breathing and relaxation, and within about another 15 minutes the SVT had stopped and the hot flash had lessened significantly (but did not completely go away).  Today I feel fine other than being tired (from interrupted sleep) and still having slight hot flash.  I took my temperature and it is very slightly elevated (98.8 F) from my normal (around 98.2 F).  I have not previously had any side effects from a seasonal flu vaccine, which I have been receiving for many years.  I did not previously have any side effects from either of my two doses of Covid19 vaccine.  While an unpleasant episode, even if I had known beforehand that it would happen, it would not have stopped me from getting my vaccines.  Thank you.
The pt experienced four episodes of shaking spells followed by two to three minute episodes where the pt appeared dazed but did not lose consciousness.
I had my shot at 1:00 pm, I went back to work and felt a little disoriented and my arm ached.By 5:00 pm that same day, I got a  heavy,wheezing feeling in my chest and coughed and coughed, my body was aching,my eyes got very red and irratated, aprox 3:00 am i woke up and my eyes were swollen and almost matted shut.went to the Drs the following day at 10:30 am. And she said she does not beleive it was from the shot she belives I just"happened to get a virus on the same day. I do not believe this is the case. normally if I get sick my neck glands start hurting a couple days before I come down with something, and I was completly fine before the shot. The Dr. told me to take tylenol cold medicine,benadryl, and rest. Today I stayed home from work again, as for I am aching bad and very weak feeling, however my low grade fever has not come back yet today.
temperature excursion which was administered to multiple patients.; No additional AE's reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's historical drugs or reactions,pertinent medical history and concomitant medications.  On 06-APR-2021 the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA)(PROQUAD)  with dose reported as 1 administered subcutaneously (lot number T031602 and expiration date 15-MAR-2022) for prophylaxis (vaccination scheme frequency and anatomical location were not reported). It was stated that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of minus 11.5 degree Celsius. This excursion had a time frame reported of 25 minutes. No previous excursions were reported and information was provided via data logger. No additional adverse event was reported and patient was asymptomatic.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA002751:
H1N1 vaccination at school. Initially complained of SOB, cold flashes, chest tightness;10 minutes later c/o staying cold, nausea with 2 bouts of vomiting; pain between scapula in back; occasional cough. At 9:50 a.m. BP 150/82, P 72, R 45; Epinephrine .3cc SQ L arm administered at 9:54 A.M. Reported slight improvement in breathing effort at 10:10 AM. Transported by EMS to Hospital at 10:16 a.m. Follow up with parent on today states that at the hospital they told her the child had allergic reaction to vaccination.  States they sent him home and he is fine now.
herpes blister right in front of mouth on lower lip; sore arm; little swelling; little headache; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (herpes blister right in front of mouth on lower lip), PAIN IN EXTREMITY (sore arm), SWELLING (little swelling), HEADACHE (little headache) and FATIGUE (tiredness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     .  Concurrent medical conditions included Blood pressure and Allergy.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ORAL HERPES (herpes blister right in front of mouth on lower lip), PAIN IN EXTREMITY (sore arm), SWELLING (little swelling), HEADACHE (little headache) and FATIGUE (tiredness). At the time of the report, ORAL HERPES (herpes blister right in front of mouth on lower lip), PAIN IN EXTREMITY (sore arm), SWELLING (little swelling), HEADACHE (little headache) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure pills and allergy pills (unspecified).  Treatment information was not provided.
pt recvd vax & had fever & myalgia; had chills x 2 wks after vax; hepatitis puncture; hepatitis core igG AB + ve;
I received the vaccination from a pharmacist and she used a sterile needed and also used gloves and sterilized the area with alcohol. My symptoms are; Red, Swollen, hot, burning, hard lump under the skin and painful area at injection site and the whole top of the arm. Symptoms continued for days and days and got progressively worse. Pain and redness spreading from the injection site to the whole top of arm and under arm pit. I couldn't take the pain anymore so I went to see a doctor. The doctor informed me that the injection site was infected with a bacterial infection. I was prescribed antibiotic today 11/26/2014 as of today it has still not cleared up. I still have a painful, swollen arm.
VACCINATED AT CORRECT AGE OF 12 YEARS,  REPORTED BY MISTAKE.
first dose of the vaccine on 23Feb2021/ tested positive on 08Mar2021; tested positive; This is a spontaneous report received from a non-contactable consumer (patient's housewife). This consumer reported similar events for two patients. This is the second of two reports. A male patient (reporter's husband) of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), on 23Feb2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The caller stated that they received the first dose of the vaccine on 23Feb2021 and her husband was tested positive on 08Mar2021 and their second dose is scheduled on 16Mar2021. She stated she understood they need to be isolating and she assumed they shouldn't go back for the second dose if it was within the 10-day quarantine period they need to reschedule the appointment. The case was reported as non-serious. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot not be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021257947 same reporter/product/events, different patient.
Frequent vomiting for 48 hours, followed by severe diarrhea for the next 72 hours. Vomiting/diarrhea for five days total.
My left arm where I record the shot was sore, but not terrible. My left ankle started aching and later my lower left left and ankle  were sore and stiff.  That was same day. The next day I really wanted to just lay around and sleep. This morning, on day two, it seems to be almost gone. At almost 24 hours after the shot I noticed I have a swelling under my left arm.  It may have started yesterday but I didn?t notice until I showered today. It is a little sore,  so having never had a swelling there concerned me but I see it is normal for the arm that got the shot. My other armpit feels like the same old 61 year old arm pit.
Patient is fully vaccinated. Presented to ED 11/28/2021. COVID + on 11/28/2021. Chief Complaint: nausea, fatigue. 77-year-old male presents to the ED complaining of umbilical abdominal pain that lasted for 2 minutes, nausea, fatigue for the past day. Patient states that around 5 PM today suddenly developed intense umbilical pain that lasted for 2-3 minutes, coming by nausea and 2 bouts of vomiting with no blood in vomit then completely resolved on its own. Patient states that he was discharged from rehabilitation after surgery on his left foot. Patient denies any exposure Covid-19, states has been vaccinated. Patient states is completely asymptomatic with no nausea, abdominal pain present. Patient denies any chest pain, shortness breath, fever, chills, diarrhea, constipation, urinary symptoms. Patient has left walking boot due to recent tib-fib surgery. BP 118/64  | Pulse 72  | Temp 98.2 °F (36.8 °C) (Oral)  | Resp. 17  | SpO2 93%  CXR: Emphysematous changes with no acute process. AKI (acute kidney injury): new and requires workup. 1 L fluids given. Pneumonia due to COVID-19 virus: new and requires workup. Recommended admission, but patient declined. Patient has COVID 19 diagnosis but completely asymptomatic now, not hypoxic and denies SOB or CP so patient will be discharged. Patient will be discharged to follow up with PCP, given information for monoclonal antibodies, given steroids and Zofran prescriptions. Patient is non-toxic appearing, no acute distress, no labored breathing, no hypoxia noted. Stable for discharge.
Dizziness; weakness; muscle pains; nausea; muscle soreness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient said she got the vaccine yesterday and experiencing some side effects such as dizziness, weakness, muscle pains, nausea and muscle soreness (all occurred in Jan2021). Asking if it was normal to experience these and also asked if she could take paracetamol (TYLENOL). The outcome of events was unknown.  Information on the lot/batch number has been requested.
Initial report received from a consumer's parent on 26 August 2010. A patient (age and sex not reported), with a medical history of asthma and allergies to peanuts, nuts, and shrimp, received on 08 June 2010 an injection (route and site not reported) of MENACTRA, lot number U3334AA. The patient had no illness at the time of vaccination, no other vaccinations within 4 weeks prior to MENACTRA and had no adverse events following prior vaccinations. The patient developed symptoms which began with a rash and losing weight (greater than 10 pounds). The symptoms progressed to hives, swelling of the jaw, Bell's palsy, and weakness in the right leg. The patient also had an increase in heart rate. The patient was hospitalized more than once due to the symptoms. The patient was tested for Lyme disease times 4 with negative results. The patient was seen by several doctors including infectious disease and a neurologist. The patient was being looked at for Guillain-Barre syndrome (GBS). The outcome was reported as not recovered. Documents held by sender: None.
Overall flu like symptoms and extreme weakness now lasting 12 days. Insomnia for 8 days. Extreme pain from hips up back to neck, and ribs front and back still continue. Periodic cold sweat mainly in the mornings and sense of unsteadiness in my head.
VOMITING; SEVERE SHAKING; HIGH HEART RATE; FEVER OVER 100.2; This spontaneous report received from a health care professional . The patient's weight, height, and medical history were not reported. It was not asked if the patient had any allergies. It was unknown if the patient consume alcohol, smoke and if there was any drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 05-MAR-2021; 04.45 pm, vaccination site not reported, for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 06-MAR-2021, the patient experienced vomiting, severe shaking, high heart rate, and fever over 100.2. Patient was given injection around 4.45 pm on 05-MAR-2021 and adverse events of severe shaking, fever over 100.2, high heart rate and vomiting started about 45 minutes ago. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, severe shaking, and fever over 100.2, and the outcome of high heart rate was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: Vomiting, severe shaking, high heart rate, and fever over 100.2.. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship. There are no other factors more likely to be associated with the event(s) than the drug.
CRAWLING UPS THE STEPS LIKE A DOG WITH BLOOD CLOTS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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, 1 total administered , start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch number No concomitant medications were reported. On an unspecified date, the reporter stated that '' she had heard of someone "crawling up the steps like a dog with blood clots". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of crawling ups the steps like a dog with blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211050432-covid-19 vaccine ad26.cov2.s-crawling ups the steps like a dog with blood clots. This event(s) is considered unassessable. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
she already got COVID; she already got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she already got COVID". Clinical Course: Reporter's wife is doctor she, she got all, she had the required, by the hospital that she works at, to get the vaccine, she got all Pfizer, and she got all 3 but she already got COVID.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Headache, sore throat, low grade fever, diarrhea, and body aches.  The symptoms lasted for a day and a half.  I took tylenol and slept most of the time. Symptoms got better and totally went away. I felt fine on the second day after the shot. I didn't seek medical treatment for the symptoms.
feel like a complete vegetable and fuzzy headed; bad body aches, hurts to move around; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel like a complete vegetable and fuzzy headed) and PAIN (bad body aches, hurts to move around) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hernia. Concomitant products included LOSARTAN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), LEVOTHYROXINE SODIUM (SYNTHROID) and PARACETAMOL (TYLENOL) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced FEELING ABNORMAL (feel like a complete vegetable and fuzzy headed) and PAIN (bad body aches, hurts to move around). At the time of the report, FEELING ABNORMAL (feel like a complete vegetable and fuzzy headed) and PAIN (bad body aches, hurts to move around) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.