chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INJECTION SITE IRRITATION; INJECTION SITE SWELLING; INJECTION SITE REDNESS; This spontaneous report received from a patient concerned a 33 year old female. The patient's weight was 145 pounds, and height was 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, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced injection site irritation, injection site swelling, and injection site redness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site swelling, injection site redness, and injection site irritation. This report was non-serious.
Weak; achy; He symptoms has moved to his arm, muscles aches in both of his arms and legs, joint pain in his right knee, right shoulder and right arm; he started having pain in his right knee and right shoulder.; he started having pain in his right knee and right shoulder.; Tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), PAIN (achy), MYALGIA (He symptoms has moved to his arm, muscles aches in both of his arms and legs, joint pain in his right knee, right shoulder and right arm), the first episode of ARTHRALGIA (he started having pain in his right knee and right shoulder.) and the second episode of ARTHRALGIA (he started having pain in his right knee and right shoulder.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weak), PAIN (achy), MYALGIA (He symptoms has moved to his arm, muscles aches in both of his arms and legs, joint pain in his right knee, right shoulder and right arm), the first episode of ARTHRALGIA (he started having pain in his right knee and right shoulder.), the second episode of ARTHRALGIA (he started having pain in his right knee and right shoulder.), FATIGUE (Tired) and PYREXIA (Fever). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency and STEROIDS at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weak), FATIGUE (Tired) and PYREXIA (Fever) had resolved and PAIN (achy), MYALGIA (He symptoms has moved to his arm, muscles aches in both of his arms and legs, joint pain in his right knee, right shoulder and right arm) and the last episode of ARTHRALGIA (he started having pain in his right knee and right shoulder.) had not resolved.            Patient had symptoms  after second dose of Covid-19 Vaccination. Patient took treatment medication Nyquil . Patient went to Doctor for pain in his right knee and shoulder. He had the X-Ray and other labs done as reported. He was given steroid shot which gave relief from his symptoms for about 5 to 10 days. The pain returned later and Patient to urgent care and he was given steroid shot again for his symptoms. Patient had been to 5 different doctors and had repeated steroid treatments for his symptoms which had spread to his arm, muscle aches in both of his arms and legs, joint pain in his right knee, right shoulder and right arm as reported. No information is reported for the outcome of events.
Didn't bother me till the next day painfully as I leaned on it. Just thought is was sore, but started noticing it in exerceses, sharp pain in arm. Couldn't sleep pn left side for the pain. Decided I had better ask if it was normal after it was still bothering me for over a week. Still after 2 weeks places still sore and at times bothers me. But seems to be getting a little better now, as I don't notice it quite so much. feels like a needle is in there. Treatment with Tylenal, Motrin, Ice packs. better ofter three 1/2 weeks.
11/22/2022 - I thought I was coming down with a cold. I had a runny nose, fatigue and  sore throat 11/22/2022. After I tested positive I developed a fever of 103.7 fever. I was prescribed Paxlovid and it worked wonderfully.
About 6 inches around the shot had a raised red inflamed area that was warm to the touch the next day. By day 2 the area had spread to about 8 inches and became blistered. It took about a week for it to clear up. I never had any pain with it. I still have a red patch a month later where the skin had blistered. I have sensitive skin and I'm allergic to rubbing alcohol but the nurse did not use any when she gave me my shots. The other arm where I received the Hep b shot had no reaction.
Large area of redness to L deltoid to axillae area warm to touch 5cm redness.
Information has been received from a pharmacist concerning two patients who on an unknown date were vaccinated with a dose of ZOSTAVAX (Merck) (lot # not provided) for prevention of shingles. Subsequently, after receiving the vaccine the patients experienced rashes around the injection site. The patients sought pharmacist attention. Follow up information received on 07-MAY-2007 from the pharmacist stated that the patient was vaccinated a couple of days prior to 21-APR-2009 with a dose of ZOSTAVAX (Merck) (lot # 664091/0140Y) by another pharmacist. This is one of two reports from the same source. Additional information has been requested.
Adverse reactions:  sweating, increased heart rate, swelling of the airway.  Cold compress applied to forehead, 5ml of Epinephrine    at 11:06am  ambulance called at same time as first does of epi,   5ml of epinephrine at 11:15am.  Paramedics on site at 11:13, administered Benadryl IV shortly after second dose of epinephrine.  Patient transported to clinic for monitoring.
25 hours after the vaccine I got an exceptionally strong taste of raw fish in my mouth  (I would describe it as licking a trout straight out of a lake) and pronounced odor of the same when exhaling. No one else around me could smell any fish nor was there any fish in the home. It lasted for two hours and then subsided with no other effects.
Patient refuses to bear weight on left leg.  Shot was in left thigh.  No apparent tenderness, redness, swelling on affected leg.
Breakthrough varicella 2/8/01 with complication of cellulitis with (bacterial super infection).
mom reports 26JAN93 immun were given; taken to ER; blue & eyes rolled back; had a cold but mom felt was better; felt hot (did not take temp); told was febirle sz;
Information has been received from an office manager concerning an 18 month old female who was vaccinated with PNEUMOVAX vaccine, instead of PREVNAR vaccine on the leg. Secondary suspect therapy included poliovirus vaccine inactivated (manufacturer unknown) on the same leg. On an unspecified date the patient developed inflammation on her leg. The patient was brought to the emergency room but was not admitted to the hospital (hospital demographics unspecified). Subsequently, the patient recovered from inflammation on her leg. Follow up information was received from the office manager who reported that a medical assistant was filling in for a nurse on maternity leave. The medical assistant was not very familiar with pediatric vaccines and misread the order for the patient. When the problem was realized, the mother was contacted. At the time of reporting, the patient was fine. Additional information is not expected.
Starting 2-3 days after 1st dose silver dollar sized lesion to right leg. Started off as red with itch then got darker and warm to touch lasting approx 14 days. Then another lesion appeared with similar course.  Thus far patient has had total of 10 lesions come and go to legs, arms.
Temp. 101,  Arm pain, Bad headache, Upset stomach, Body pains. Cleared up the next day.
This spontaneous report as received from an Immunization Official refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The reporter stated that the patient received GARDASIL that was stored improperly at 31F for 84 hours. The patient was not experiencing any known symptoms. Additional information has been requested.
Had a shingles rash about 7 weeks ago; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (Had a shingles rash about 7 weeks ago) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Had a shingles rash about 7 weeks ago). At the time of the report, HERPES ZOSTER (Had a shingles rash about 7 weeks ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and Treatment medication were reported.
I had a flare of my rheumatoid arthritis in my right knee with severe swelling almost 2 weeks after receiving my 1st COVID vaccine. My rheumatologist expressed that this may have been related to receiving the vaccine.  I received a steroid injection in my right knee to resolve the swelling/pain. The steroid did resolve the swelling/pain.
This spontaneous report as received from a nurse practitioner refers to a patient (gender and age not reporter) which was vaccinated with PNEUMOVAX23 (dose and route not provided) which was exposed to 11.5 C for 102 hours. No adverse effect reported. Lot number H022281 is an invalid lot number for PNEUMOVAX23. This is one of several reports received from the same source. Additional information is not expected.
66 yo WF with PMH asthma, allergic rhinitis, morbid obesity (112kg), chronic low back pain with sciatica, hyperlipidemia, CKD 3a, endometiral CA was at the clinic for COVID19 Moderna Vaccination.  History of allergies to Paclitaxel (anaphylaxis) and adhesive tape (pruritis).  Takes allergy shots 3 x week.  Dose given in patient's left deltoid at 1600 (lot # 011J20A).  At 1630 patient started to complain of dry eyes. Patient took 5mg levocetirizine from her own supply with no relief. Patient was registered to urgent care for further evaluation and management. Patient started to clear throat and complain her throat feels swollen and her mucus was thick. BP elevated 160's.  Solumedrol 125mg IV given at 1702;
12/21/21 11 PM - shaking, chills and sweats, followed by achiness that got worse throughout the night. I took Tylenol, which didn't do much. I had a fever, though I don't know how high, as I was too sick to get out of bed. I was completely incapacitated with severe aches for about 12 hours. After that, I still was not able to function for another 24 hours because I felt so poorly and fatigued.  12/24/21 Developed very sharp and sudden pain on my right side, under the ribcage in front and the back. I went to the ER, where tests did not show anything. Within 6 hours, the pain became intermittent, and finally ended on 12/26 21
Itchiness & had hives - given antihistamines. Went to several allergy doctors had shots. Still has red rash on body - quit taking antihistamines. Symptoms began 10 days after the flu shot. No hx of allergic reactions. Went to hives in December almost progressive. No reaction at the time no tenderness.
This case was reported by a consumer and described the occurrence of weird feeling in a 54-year-old subject who was vaccinated with FLULAVAL (trivalent or quadrivalent unspecified, GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included appendectomy and deep vein thrombosis. On 18 October 2013 at 11:09 the subject received 1st dose of FLULAVAL (.5 ml, unknown, right arm). On 18 October 2013, immediately after vaccination with FLULAVAL, the subject experienced "felt fluid go in his right arm and a weird feeling a second afterwards". On 19 October 2013, the subject experienced injection site pain, fever, night sweat, arm pain, shoulder pain, woke with increased pain and shoulder blade pain. On 20 October 2013, the subject experienced pain in rib cage. On 21 October 2013, the subject had musculoskeletal chest tightness and difficulty breathing. On unspecified dates, within days of vaccination the subject experienced dyspnea with conversation, contraction of chest muscles and gasping for breath. The subject reported that he received the FLULAVAL vaccine on 18 October 2013. He stated that after the vaccine he remembered that he felt fluid go in his right arm and a weird feeling a second afterwards that was very unusual from previous flu vaccines. He stated he has never gotten a GSK flu vaccine before. The needle was larger than previous times he had the vaccine as well. The subject stated that he did not have any side effects until the next day when he began to hurt at the injection site. That night he developed a fever, night sweats, extreme right arm and shoulder pain. He said he woke up in the middle of the night because of the pain and could not go back to sleep. The fever and night sweats resolved that evening. On 20 October 2013, he stated there was significant pain in his shoulder blade and rib cage. He took 600mg ibuprofen that did seem to help. The subject reported that on the morning of 21 October 2013, his shoulder and arm did not hurt anymore, but that his rib cage and chest muscles were tightening and firing and that he was having trouble breathing. He reported he almost called an ambulance because of the pain. The subject said he could not breathe well enough to talk until 23 October 2013 and he called his pharmacy. The pharmacy referred him to GSK. The subject reported that his chest muscles contract every three seconds and whenever he takes a deep breath or talks. He said he is usually very healthy and does not get sick. The subject has not contacted his physician. The subject stated that he is improving slightly, but can be heard gasping for breath during the conversation. The subject denied chest congestion, cough, headache or other health problems. At the time of reporting the Injection site pain, fever, night sweat, arm pain, shoulder pain, shoulder blade pain were resolved; difficulty breathing and chest tightness were improved; pain in rib cage, dyspnea with conversation, contraction of chest muscles and gasping for breath were unresolved. The outcome of woke with pain and weird feeling were not specified.
Pt vaccinated with DTP then "cried hysterically" for 8 hrs after injection.
This case was reported by a other health professional via sales rep and described the occurrence of skin abrasion in a adult female patient who intended to vaccinate a patient with KINRIX. On 1st December 2017, the patient received KINRIX .5 ml. On 1st December 2017, immediately after receiving KINRIX, the patient experienced skin abrasion, needle injury, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the skin abrasion, needle injury, inadvertent exposure to vaccine and exposure via skin contact were unknown. It was unknown if the reporter considered the skin abrasion and needle injury to be related to KINRIX. Additional details were provided as follows: This case was reported by a medical assistant (MA), who reported the case for herself. The age at vaccination was not reported. The child jerked and the KINRIX needle grazed the nurse's knuckle, which led to inadvertent exposure to vaccine and exposure via skin contact. No adverse event reported necessary for child, since the event occurred prior to injection. The dose wasted due to contamination and a new KINRIX dose was used for vaccination to the intended patient (vaccine).
pt recv vax SEP95 & on15JUN96 pt exp breakthrough chicken pox on belly & back;
fever of 101F that began approximately 12 hours after vaccine administration and lasted less than 24 hours.
Pt is 39 yo female with PMH of Type 2 diabetes, HTN, and obesity. She received Pfizer COVID-19 vaccination dose #1 on 3/8/2021 and dose #2 on 4/5/2021. On 4/28/2021 pt undergoes COVID-19 testing with symptoms of sinus stuffiness/pressure that started the day prior. Denies any other s/s of COVID infection. COVID test results positive on 4/28. Pt meets criteria for Bamlanivimab/Etesevimab infusion and receives this medication on 4/30.
6-7 cm red, itchy area at site of injection site approx. 2 cm of induration.
Acid Reflux Disease. Anxiety. Below Average Intelligence. Bipolar. Depression. High Blood Pressure. High Cholesterol. Psychological Disorder. Migraine.
10-27-08 telephone call from childs Mother.  She states on 10-20-08, child developed "hives" on his back and arms. No fever and no resp. distress at this time.  Child was seen by school nurse the next day.  RN (school nurse) reports hives were on back, stomach, arms, legs and neck.  Mom was notified and picked child up from school.  Mom took child to Emergency room immediately.  States child had "a little wheezing."  Benadryl administered by ER staff.  Mom told ER staff about previous vaccinations but states they were uncertain of what may have caused the hives. Benadryl was administered to child at E.R. Hives got better after 24 hours. Hives returned next day, child was taken back to E.R. and Benadryl administered again. Hives resolved as of 10-26-08.  Neither time the E.R. could determine cause of illness, per Mom.
Patient dropped to the floor and hit her head shortly after being immunized with Prevnar.  CPR administered on site.  Patient later died at hospital.  Dr./coroner believes it was not related to the shot but rather a pulmonary embolism.
Information has been received from SPMSD (case report # DE-1577272925-E2015-07393) on 23-JUL-2015. Case of medication error was received from a physician on 23-Jun-2015. Case is medically confirmed. A 6-year-old female patient received two doses of GARDASIL (lot-nos. not reported) on unspecified dates in 2001. The patient was vaccinated. The vaccinations were only documented handwritten (no batch label in vaccination documentation). No information regarding an adverse event was given at the time of this report.
AT THE TIME OF THE VACCINE I HAD A SHARP STINGING PAIN AT THE SITE THE STINGING PAIN WENT AWAY BUT WAS REPLACED WITH A DULL ACHE THAT CONTINUES NOW. WHEN I TOOK OFF THE BANDAID I NOTICED INJECTION WAS GIVEN AT THE VERY TOP OF MY SHOULDER NOT IN THE DELTOID (I AM A PEDIATRIC NURSE FOR 30+ YRS)  I CALLED MY PRIMARY PROVIDER WHO I SAW ON 09/17/2020 AND WAS GIVEN A TELEMED VISIT ON 10-05-2020 I EXPLAINED TO HER THE PAIN THAT I WAS HAVING AND SHE LOOKED AT MY ARM AND STATED THERE WAS NO SELLING OR BRUISING I TOLD HER VACINE WAS GIVEN TOO HIGH. SHE ADVISED ME TO TAKE TYLENOL AND ICE THE AREA (WHICH I WAS DOING WITH NO RELIEF) AND IF IT CONTINUED TO CALL HER BACK. PAIN CONTINUED AND I SAW DR
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 08 years old female patient for whom nurse gave a 2nd dose of the FLUZONE QUAD to the female on 02Oct2018 at school flu clinic for which she had signed consent form without knowledge that the female had a prior FLUZONE QUAD vaccination at her PCP's office was reported, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient did not received any concomitant vaccines. On 02-Oct-2018, the patient received a second dose of suspect Influenza Quadrival A-B Vaccine lot, UJ025AC via unknown route in the left deltoid. On 21-Sep-2018 she also received a first dose of the same vaccine, lot U6260AA via unknown route in unknown administration site. The nurse gave a 2nd dose of the FLUZONE QUAD to the female on 02-Oct-2018 at school flu clinic for which she had signed consent form without knowledge that the female had a prior FLUZONE QUAD vaccination at her PCP's office (extra dose administered) unknown latency following the administration of Influenza Quadrival A-B Vaccine. No reactions reported and the child has attended school every day and has been fine. It was a case of actual medication error due to extra dose administered. Final diagnosis was nurse gave a 2nd dose of the FLUZONE QUAD to the female on 02Oct2018 at school flu clinic for which she had signed consent form without knowledge that the female had a prior FLUZONE QUAD vaccination at her PCP's office. It was not reported if the patient received a corrective treatment. The event outcome was not applicable. 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. Documents held by sender: none.
exposed to COVID; she got a flu shot that same day; losing control over her urine/Constant urination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 71 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 29Sep2021 as dose number unknown, single. The patient's relevant medical history included: "Allergies" (unspecified if ongoing); "Diabetics" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 2, Anatomical site of injection: Arm left,, Batch No: EN6201), administration date: 21Feb2021, when the patient was 70-year-old, for Covid-19 Immunization, reaction(s): "losing control over her urine / constant urination"; BNT162b2 (Dose 1, Time: 15:00, Anatomical site of injection:  Arm left,, Batch No: EL9262,513121, Expiry Date:03May2021), administration date: 31Jan2021, when the patient was 70-year-old, for Covid-19 Immunization, reaction(s): "losing control over her urine / constant urination". The following information was reported: URINARY INCONTINENCE (medically significant) with onset 2021, outcome "recovered" (13Nov2021), described as "losing control over her urine/Constant urination"; PRODUCT USE ISSUE (non-serious) with onset 29Sep2021, outcome "unknown", described as "she got a flu shot that same day"; EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "exposed to COVID". The event "losing control over her urine/constant urination" required physician office visit. Reported that at the time of report it has been 6.5 weeks without an episode. She was recently exposed to COVID by a 98-year-old man that had to go to the hospital on Monday (as reported) so she was hoping she doesn't get it, stated that she knew a few people that got COVID from that man. It was stated that her doctor moved up her date for the booster because her brother isn't doing a good job with the COVID guidelines, they moved her shot up 5 weeks. Her doctor told her to wear a mask in her own house. Her doctor moved it too because she was diabetic. The action taken for influenza vaccine was unknown.