chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching; hives; Rash; This is a spontaneous report from a contactable consumer or other non hcp.   A 64-years-old non-pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6207; Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 09Mar2021 13:30 as 1st dose, single for COVID-19 immunization. Medical history included rheumatoid arthritis from 1999 to an unknown date, hypertension from 2001 to an unknown date, blood cholesterol increased from 2002 to an unknown date, sleep apnea syndrome from an unknown date. Concomitant medications included folic acid, methotrexate sodium, tofacitinib citrate, metoprolol tartrate taken for an unspecified indication, start and stop date were not reported. Caller says they have not had any other recent vaccinations or started any new medications. Caller says she hasn't had any vaccinations for a year and the last one was for shingles  a year ago.The patient previously took Vicodin, valtaran, ciprofloxacin, actemra and experienced allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Mar2021 16:00, after first dose on Tuesday March 9th, and 2-3 days later she started itching and breaking out in a rash that is not better and is still spreading. She says that everything she can find on the internet says that the rash is mostly from Moderna. She says that she would like to know if others have reported having issues with this, or if this is something she should be worried about. Caller says that the itching started a little at first, and then the rash took off by Friday. She says it was mostly around her neck, but the last couple days it has gone down onto her torso and her arms. She says she has been treating it with Benadryl and Hydrocortisone cream. She says she is going to her doctor tomorrow to see if she can get some sort of shot or something. She says that the hydrocortisone cream is Ultra Moisturizing Hydrocortisone Cream with EXP Oct 2022 and LOT 0LT0491. She says that there is a barcode on the tube but there are no numbers on it below there. She says that she threw away the outer package. She says that she used it twice yesterday and once today, she really only uses it when it starts to itch really bad. She says when she called her doctor Sunday he said to take two Benadryl 25mg tabs, so take 50mg every 6 hours by mouth  Therapeutic measures were taken with steroid pack. The clinical outcome of the events was recovering.     Information on Lot/Batch number was available. Additional information has been requested.
Patient became pale, started sweating, got dizzy, blood pressure dropped to 106/68, but patient stated (after getting vaccinated) this happens to him every time he  gets a vaccine. He laid down on the ground, legs were raised. He refused to let me check the BP again stating this will only drop it more. When fire rescue arrived he refused to go to the ER
Tingling feeling in both feet, resonating up to knees lasting for 2.5 days.
ITCHY RED RASH; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (ITCHY RED RASH) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In June 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced RASH PRURITIC (ITCHY RED RASH). In 2021, RASH PRURITIC (ITCHY RED RASH) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.
She got her vaccine at about 5:30 and everything was fine, had dinner brought in, had guests.  She went to bed around 11:00 and then she woke up violently shaking and could not move her body, felt paralyzed other than the shaking.  Her grandson was visiting her and he heard her moaning and came in and said "not again" as she had a similar reaction to the COVID vaccine and was present at that time as well.  She did not go to the ER as she had experienced this before.  She also does not  like to expose herself and does not go out.  It lasted for about 30-45 minutes and then for 2 days she felt very weak and not herself.  After that period she was okay and could get up and move about, but was extremely fatigued for several days thereafter.    This is the same exact reaction she had to the COVID vaccine on 8/31/2021.   She also had her Fluzone vaccine on that day as well and was advised not to get the booster vaccines due to this reaction.
Information has been received from a physician concerning an 18 year old female who on 15-OCT-2007 was vaccinated with the 2nd 0.5ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). In October 2007, the patient experienced extreme pain, tenderness, dizziness and nausea. The patient did receive unspecified medical attention and recovered on 17-Oct-2007. Per the doctor, the patient did not experience any AEs after receiving the 1st dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Additional information has been requested.
Information has been received from a physician concerning a 34 year old female patient who was vaccinated with 5-6 doses of rubella virus vaccine live (second generation) over the last 10 years. In February 2002, a titer was drawn which did not show seroconversion. The patient sought unspecified medical attention. Follow-up information received from the physician indicated that a review of records revealed that the patient did not have rubella virus vaccine live (second generation) recently, as if was thought. No further information is available.
No adverse event, other than administering Moderna, rather than Pfizer. Father requested Moderna Booster. .25Moderna IM R deltoid
Flu like symptoms.  Muscle/body ache, chills, lethargic, fever like feeling but normal temperature, and dull but painful headache.
received third dose of shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 82-year-old male patient who received Herpes zoster (Shingrix) (batch number 27224, expiry date 08-MAR-2024) for prophylaxis.   Previously administered products included Shingrix (completed Shingrix series back in December 2020).   In NOV-2022, the patient received the 3rd dose of Shingrix. In NOV-2022, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received third dose of shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 24-May-2023 A pharmacist asked for safety information.  During the call permission for follow up was not requested. The patient received the third dose of Shingrix, which led to extra dose administered.
At approximately 8:30 AM patient received 2nd dose of Pfizer vaccine in the right arm at the Public Health Center's drive through vaccine clinic. She was accompanied by her husband who was driving her vehicle. At 8:34 AM she notified staff in observation parking area that she felt dizzy, chest pain, and reported wheezing. Two RN's responded at 8:34 AM to observation parking area with emergency kit. Upon arrival, patient verbalized again that she felt dizzy, chest pain and tightness now,  no audible wheezing heard, patient's skin was pale, and her respiratory rate was high. Advised patient to take slow deep breaths and to try to relax and remain calm.  No improvement. At 8:36 AM called 911 for the patient to be evaluated. While one RN was on the phone with 911 operator, patient reports to the second RN throat pain/ tingling, difficulty swallowing, a feeling of a "lump in her throat", continued chest pain and tightness, and states that she feels she cannot breathe in or out well. Per standing order Epinephrine 0.3 mg administered in the right thigh IM. Both RN's remained on scene. No improvement, and patient continued to state it was getting harder to breathe, and that her throat was tingling and she could hardly swallow. At 8:44 AM 0.3 mg Epinephrine administered in the left thigh IM per standing order.  At 8:50 AM EMS arrived. Patient had improvement. Vital signs stable upon arrival per EMS. Breathing difficulty improved upon EMS arrival.  No further difficulty swallowing reported. Chest pain reported to be improved as well. 8:55 AM EMS transported patient to local hospital.  Attempted to contact the patient on 04-26-2021 to determine outcome of event. Phone went to voicemail. Voice message left.
The first 3 days i had chills weakness headache and small pimples on my tongue. My arm was soar .after the 3 days i went back to normal  on Jan 22 i wake up with pain in left arm i thought it was due to my neck issue   Sunday the 24 th noticed that my Arm is swollen and red  check with a primary care provider and been told that i hv cellulitis  that he thinks it is from the injection . The Physician prescribed  immediately doxycycline 100 mg twice a day   for 10 days ..  on the 25 i informed my care provider . I started the Antibiotics Jan 24th at 8:00 pm.
Presented to clinic 08/01/06 with c/o HA, smallpox site soreness, and bumps to head times 3 days. Poxlike lesions observed to face/scalp. L arm pox site inflammed. Left Otitis Media noted. Diagnosed with smallpox viremia as well. Orders given for Motrin and Zithromax. Quarters times 24 hours and follow up at clinic the next day.
We are completing this form due to state specifics policies that state that due to age the PNEUMOVAX vaccine had to be administrated.  So far, the patient doesn't present any adverse event.
Patient broke out in welps and hives for 3 days - covered patients face, back, stomach, legs, and arms. Treated with Benadryl.
8 to 10 hours after injection joints throughout my body became very sore, a few days later knuckle on right hand swollen and very sore, i thought it was just coincidental, I did  see my Doctor a few days later because the over the counter pain meds were not being very effective, he gave me toradol and told me i could take 10 mg prednisone in am for three days that i had on hand, eventually I got better, i then got my second dose and I had a repeat of the joint pain and swelling of my knuckles on the right hand, this to was better after 3 or four days after using the same treatment, I never felt that it was life threatening but thought I should report it, my joints are still sore but they are debilitating and i am improving each day.
pt. received only the diluent portion of Menveo on 7/2/2021; pt. received only the diluent portion of Menveo on 7/2/2021; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 2nd July 2021, the patient received Menveo. On 2nd July 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No side effects were reported. The reporter consented to follow up.  Note: Patient initials were kept as it is, as no query response was available yet.
pt had a positive COVID test on 9/5/22 at (Privacy); DNI/DNR/no feeding tube; pt admitted to hospital on 9/13/22 with worsening SOB, cough, hypoxia and poor oral intake; CXR showed right middle and right lower lobe pneumonia; IV ABX, Remdesivir, Dexamethasone and Vitamin C given; pt dc'd to (Privacy) on 9/21/22 where she passed away
First my child had 105.1 fever within 36 hours. She also vomited for a week after she ate ANYTHING. Being a breastfed baby, she did well with breastmilk, baby food & soft foods until after this shot. She never had vomited before. Next, all her joints would be stiff at different times for 10 days. Lastly, she would often stare of into space for several minutes at a time (5-10). This lasted about a month. She was in a daze. Also, she had never done this before. It was months before she returned to her normal self.
Mom called 10/5/18 to state patient had 102 temp, with body aches and chills on 9/29/18 last until 9/30/18 (lasted 24 hrs) then was fine.
Patient describes pain at site.  Painful to touch on scale of 0-10 rates pain at a 5.  Patient took 4 Ibuprofen 200 mg with no relief.
Intense itching at injection site the night of and day following injection. Redness and swelling as well.
Injection was uncomfortable. Within 15 minutes my arm felt numb and painful.  Within a couple hours the numbness subsided but pain in shoulder area persists.  I have trouble lifting my arm over my head, have pain after waking in the morning if I sleep on the affected arm, it's difficult to put my arm behind my back. Have an appointment to see an arm specialist on 10/17/2012.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 10:43 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 40.73.  Concomitant products were not provided.  On 28-FEB-2021, Excursion time was 09 AM and 1PM. temperature was 27 and 26 respectively. total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-FEB-2021, vial was moved to clinic on 27-FEB-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-MAR-2021.  On 28-FEB-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM: 37, 3 PM: 43 and 4 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
0900 Patient had allergic reaction post covid vaccine injection.  Patient has c/o chest discomfort, itching, rash on bilateral arms, denies SOB .  O2 Sat= 97% Allergies reviewed.  0910 25mg diphenhydramine administered , EKG performed as ordered.  Per provider patient to be observed for 1 hour in clinic.  Obs start time 0910,  1010 patient s/s subsided no additional complaints verbalized and patient was d/c from clinic area without further incident- released to sister.
Information has been received from a registered nurse and an administering healthcare professional concerning a 11 year old male patient with reactive airway disease, deviated septum and allergic rhinitis who on 04-JAN-2012 at 17:02 was vaccinated with a third dose of GARDASIL (lot number 670050/1229AA) I.M., right deltoid (dose not reported) at private doctor's office/hospital. Concomitant therapy included the second dose of HAVRIX (lot number AHAVB534AA) into left deltoid. It was reported that the patient received immunization that was stored at on out of range temperature, the vaccines were exposed to 30 degrees F over the 16 day period. It was reported that no reverse reaction occurred. On 30-JAN-2012, the patient was revaccinated with GARDASIL (dose, route and lot number not reported) and HAVRIX. This is one of several reports received from the same source. No further information is available.
Photophobia; incorrect dose administered; Lethargy: Rash; Malaise Information has been received from a registered nurse concerning a 19 year old male with anxiety who on an unspecified date was vaccinated IM with a first 0.5ml dose of hepatitis A virus vaccine inactivated and on 30-AUG-2005 at 14:00 was vaccinated IM with a second dose of hepatitis A virus vaccine inactivated (lot #649454/0202R). It was noted that the pediatric formulation was used for both doses. There was no illness at the time of vaccination. It was reported that "recently" (2005), after the vaccination, the patient developed a rash and became lethargic and photophobic. Unspecified medical attention was sought and the patient subsequently recovered. A product quality complaint was not involved. Follow-up information was received from the registered nurse and physician. The nurse reported that on 30-AUG-2005 at midnight, the patient was awakened from sleep with a headache, photophobia, a rash and generalized malaise. The patient was awake for about on half hour. This was reported by the mother on the phone on 31-AUG-2005. The patient slept through the night and was still asleep at the time of the call. It was requested that the mother awaken the patient and evaluate the condition. There was no return phone call. The physician reported that the patient awoke with a headache, malaise, photophobia and a rash. The patient did not report to a medical provider for evaluation. No diagnostic laboratory tests were performed. The patient recovered on 31-AUG-2005. No further information is expected.
CHILLS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache. This report was non-serious.
Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) for Vaccination.    No Medical History information was reported.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and first dose of INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) (Intramuscular) 1 dosage form. On 30-Oct-2021, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MALAISE (Malaise) and HEADACHE (Headache) to be possibly related.    No treatment medications were provided.   This case was linked to MOD-2021-370320 (Patient Link).
Approximately 6 hours after shot: extreme fatigue, mild to moderate nausea, mild lightheadedness, slight dizziness, slight headache, cold-like symptoms. Still ongoing 3rd day after shot, 2-4-21.
After second shot my wrist started hurting and later that day I developed a lump in my hand which spread to my finger, I was concerned it was a blood clot so went to urgent care they could not diagnose it  Since then I have constant pain in my fingers on my left hand unable to bend as well as lumps that come and go , a few weeks later my toes on my right foot now have constant pain unable to walk at times  3 drs have not been able to diagnose  Tonight another soft lump on my wrist  I have never had these issues until after the vaccine
strokes signs; Two blood clots in the veins in legs; This is a spontaneous report from a contactable consumer.  A 64-year-old female consumer (patient) reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EN6199/EN6207 (as reported)) intramuscular into the left arm on 10Mar2021 (at the age of 64-years-old) at single dose for COVID-19 immunization. She received the second dose of BNT162B2 dose on 31Mar2021 (lot number unknown). Medical history included high blood pressure and GERD.     Concomitant drugs included Toprol  25mg, oral , twice a day  for blood pressure stated ''in Feb some time she don't know'' and Protonix 40mg,  oral twice a day for years for GERD. The consumer reported that 'she got her first vaccine and she has had the strokes signs''. Further she reported she got her first vaccine dose, then she had leg pain, she went to see the doctor and ordered a doppler.  She was put on blood thinners and three days later she got two blood clots in the veins of her legs, right. On 20Mar2021, her leg pain went pretty severe since I had the blood clot, when I got the second shot, it was still there. On 27Mar2021 she started treatment receiving Eliquis 5mg, twice a day for the blood clot and she did take a Physical therapy. When she got the second vaccine dose on 31Mar2021 she was on blood thinners. At the time of reporting the outcome of the event was reported as 'hasn't gotten better, it's the same not better not worse.
Severe burning in both feet.   Mild burning both arms. Later three weeks after shoot pitting edema both feet and ankles
Per Observation RN, patient had a complained of hand tingling and stated that she has history of Hashimoto's disease and bilateral upper extremities tingling and anxiety Per RN, patient denied swallowing and shortness of breath. BP 111/79, HR 85,NKDA. per RN was given diphenhydramine 25 mg
Red itchy rash with swelling around the injection site. Itching started immediately after administration with a little bit of redness and swelling within a half hour the size of a dime. The next morning  on 9/26/20 it was the size of a quarter and then on 9/27/20 it was the size of a half dollar per the patient. The patient was instructed by a pharmacist to apply ice for the swelling and to take an antihistamine and use hydrocortisone cream for the itching and irritation.