chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle pain; headache; fever; upset stomach; tiredness; Shoulder pain; shivering; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 27RS1 ?, expiry date 12th July 2021) for prophylaxis.   On 29th May 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In May 2019, 11 hrs after receiving Shingrix, the patient experienced shivering and shoulder pain. On 30th May 2019, the patient experienced muscle pain, headache, fever, upset stomach and tiredness. On an unknown date, the outcome of the shivering, muscle pain, headache, fever, upset stomach and tiredness were not recovered/not resolved and the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the shivering, muscle pain, headache, fever, upset stomach, tiredness and shoulder pain to be related to Shingrix.  Additional details were reported as follows: The patient received the 2nd dose of Shingrix around 2 pm.  He woke up at around 1 am with shivering.  On 30th May 2019, 1 day after ereciving Shingrix, the patient woke up with muscle pain, headache, fever, upset stomach, and tiredness.  The patient also said that his shoulder where he got the injection hurts.  The reporter did not had the patient with her at the time of the call and was unable to clarify further the events. The reporetd batch number 27RS1 was not available in sales data sheet so captured as 27RS1 ?
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were administered improperly stored doses of PNEUMOVAX 23 lot # L019836 with expiration date 24-MAR-2017 (dose and route of administration not reported). The vaccine underwent a temperature excursion of 0.5 degrees Celsius for 2 hours. Digital Data Logger was involved. There was no previous temperature excursions. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a pharmacist and described the occurrence of expired vaccine used in a 45-year-old male patient who received ENGERIX B (batch number AHBVC034AA, expiry date 6th January 2014). On an unknown date, the patient received ENGERIX B 1 ml. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: 45 years old male received expired ENGERIX B.
I felt pretty fine throughout the day, but I took my temperature around 630/7 PM and it was 102. I also took my heart rate because I have a pulse ox machine and when I was getting ready for bed I took Tylenol and felt a little short of breath and couldn't really walk from bedroom to bathroom without getting winded. I didn't have any chills or headache or vomiting but I did have some joint pain but nothing extreme. I just felt achy throughout the day. The next day I went to the ER and they did a chest x-ray, blood test, EKG, and CT scan with contrast. The EKG did show a murmur but then they did the blood work and it showed that there was a blood clot and so then they did the CT scan with contrast and didn't see it but still suspected it. They suspected it was very small and broken up and gone at that point. Nothing happened after that. ER visit was at a local HCF.
swollen lymph node; grape size lump on the back; arm pain / I couldn't even use it.; feel like i was hit by a bus; arm pain / I couldn't even use it.; food like symptoms; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix vaccine with an associated reaction of pain in extremity (received shingrix on an unknown date, refer case US2021AMR028925).   On 3rd February 2021 19:30, the patient received the 2nd dose of Shingrix. On 3rd February 2021 21:30, 2 hrs after receiving Shingrix, the patient experienced enlargement of lymph nodes and skin mass. In February 2021, the patient experienced pain in arm, feeling abnormal, mobility decreased and influenza-like symptoms. The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the enlargement of lymph nodes, pain in arm, feeling abnormal, mobility decreased, influenza-like symptoms and skin mass were unknown.   It was unknown if the reporter considered the enlargement of lymph nodes, pain in arm, feeling abnormal, mobility decreased, influenza-like symptoms and skin mass to be related to Shingrix.  Additional details were provided as follows: The patient received the shingles vaccine the second one last night of reporting at 7:30 pm and experienced flu like symptoms. The patient stated that which was not concern. The patient was curious to know if that vaccine could cause a swollen lymph node and if it was common. The patient had a swollen lymph node on the left side back of my neck between the head and the shoulder started at 9:30 pm. The patient felt like hit by a bus. The patient experienced arm  pain on a scale of 1 to 10 the pain in my arm was a 7. The patient couldn't even use the arm. The patient was very stubborn to take medicine for pain because the patient  believed pain was what keeps you from overdoing things. But in this case the patient actually need furry Tylenol.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR028925:same reporter
Vaccine was expired by 1 day. The dose expired on 1/26/2021 but given on 1/27/2021. Patient did not have any reactions and was counseled by Primary care physician before patient left the office.
11cm X 7cm area of erythema, warmth and induration at injection site of  DTAP/HIB #4, 3 days, post vax. Cellulitic appearing. Started on Augmentin for ear infection with questionable cellulitis.
This child had extreme eczema on his face, entire body oozy and bloody from 2 month. Still has some now at 14 month, but almost clear. Used alternatives and breast milk, special baths, ointments, and creams. Now has asthma. not completely recovered.
I received my flu shot Wednesday September 18th at Pharmacy. At 1am on September 19th I woke up and had severe and uncontrollable diarrhea and vomiting every two hours. I had frequent episodes of diarrhea, vomiting, and stomach pain throughout the rest of the day, and even on September 20th I still suffered from two incidents of diarrhea. This led to severe dehydration and stomach pain, as well as a lack of appetite.
Mother called 8/20/2010 to report local reaction at both injection sites.  8/17/2010- rt anterior thigh- redness, swelling, heat and pain, "one big hive the size of a hand, with fingers of raised area extending from knee to pantyline".  Right lateral thigh- redness, swelling shaped and sized like "a medium egg", tender, and hot.  Mom treated at home with Benadryl around the clock from 8/17 a.m. to 8/19 evening at the advise of local hospital, no doctor or hospital evaluation done in person.  Mom stated it resolved by 8/20/2010 a.m. so she stopped medicating child at that point.
Blood clots to both lungs. Hospitalization and treatment with include treatment for severe pain in left shoulder blade, shoulder, left side and around to front lower left rib cage. Treated with pain relief medication, and blood thinner apixaban.
Large localized reaction of the left leg with redness and warmth spreading rapidly requiring a visit to ER for steroid administration.
This case was reported by a consumer and described the occurrence of seizure in a 49-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included hive and penicillin allergy. On an unspecified date in November 2008 at approximately 10:00 the subject received 1st dose of HAVRIX (unknown, right arm). Lot number was reported as "AHVB173AA". In November 2008, at an unspecified time after vaccination with HAVRIX, the subject experienced irregular bleeding in menstrual area, shortness of breath, hernia from pushing stock around and ovarian cyst. At an unspecified time after vaccination with HAVRIX, the subject experienced seizure, bipolar disorder, thinking slow and "people seemed like they were talking to fast and everything around her seemed to be going fast" (ill defined disorder). Her shortness of breath turned into emphysema so she has been sent for CPAP and "VPAP" [unknown] testing. She also experienced seizures, bipolar disorder, thinking was slow, people seemed like they were talking to fast and everything around her seemed to be going fast. These issues were treated with Lamotrigine which seems to be helping. She stated that she had uterine surgery and removal of both ovaries. She has been placed on estrogen to help slough off inside of uterus. This case was assessed as medically serious by GSK. At the time of reporting the irregular menstrual bleeding, shortness of breath, hernia and ovarian cyst were unresolved. The outcome of seizure, bipolar disorder, thinking slow and ill defined disorder were unspecified.
patient that evening started to have twitching to her whole body.  involved the hands mostly for 2 weeks after the vaccine and then 2 isolated episodes of facial twitching during that time.  Now 4 weeks out is still reporting continued diffuse muscle twitching to her body worse while resting or trying to sleep.
Patient called today 8/13/15 stated that at the injection site of her right arm is redness, swelling, and she can not move her arm.
8 hours post-vaccination, the patient felt tired and had pain in her lower legs, it was achy and needle like from her knees down both legs. She took 2 TYLENOL and went to bed. The next day she went to work and when she got home was unable to walk. When she took off her boots she had a blotchy red rash on the back of her calfs and her ankles and feet were swollen. She went to the ER at 10:30 PM and was admitted with possible cellulitis. In the hospital she was treated with antibiotics, TYLENOL and MOTRIN. She was seen in neurology office on 12/29/2009 for burning pain involving the soles of her feet which radiates up to her posterior legs and a weakness in the both lower extremities. Symptoms have been present for 5 weeks and have not progressed. There is evidence of conduction block and as an addition to the clinical history and physical exam is consistent with a diagnosis of a post vaccine acute inflammatory demyelinating polyneuropathy.  Follow-up letter received states - Unfortunately, this information is not available to us. We include all the information available to us in the VAERS report, but they have specifically requested that we not share their contact information with individuals who are not part of this study.
3 hours post injection, patient describes "violent nausea and vomiting" tunnel vision, unable to move limbs, confusion,  Lasted 1-15 minutes until patient was able to get on floor and crawl to couch".  "Back to Normal in approximately 30 minutes".  Patient was alone at the time of event.
EXPIRED VACCINE RECEIVED; PRODUCT TEMPERATURE EXCURSION ISSUE (PUNCTURED VIAL LEFT OUT BEYOND 6 HOURS ADMINISTERED); This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-MAY-2021, the subject experienced expired vaccine received. On 19-MAY-2021, the subject experienced product temperature excursion issue (punctured vial left out beyond 6 hours administered). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine received and product temperature excursion issue (punctured vial left out beyond 6 hours administered) was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided: yes. no pqc criteria has been identified. based on the PQC evaluation/investigation performed. This report was associated with product quality complaint: 90000180101.
done taking the Pfizer BioNtech COVID-19 vaccine and booster shot but she was tested positive; done taking the Pfizer BioNtech COVID-19 vaccine and booster shot but she was tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  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 included: "my bladder is ripped of liver injury" (unspecified if ongoing), notes: my bladder is ripped of liver injury; "my bladder is ripped of liver injury" (unspecified if ongoing), notes: my bladder is ripped of liver injury. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "done taking the Pfizer BioNtech COVID-19 vaccine and booster shot but she was tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: I was tested positive that night. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient mentioned that she was done taking the Pfizer BioNtech COVID-19 vaccine and booster shot but she was tested positive that night, so she started taking Paxlovid. She had it for two days however she cannot have full dose of it because the pharmacy in they mentioned that it was not available in their area (Further clarifications unknown).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10-month-old female with no remarkable past medical history who presents with seizure.  Shortly prior to arrival, patient had approximately 2-minute episode of shaking.  It stopped on its own.  She was very sleepy after and now she is irritable.  She was found to have a fever in triage.  Of note, patient did receive her COVID and influenza vaccine earlier today.  She has not had any recent fever, cough, congestion, vomiting leading up to this.  No known sick contacts.  Her dad notes that febrile seizures run in his family.
5.5cm red, swollen, warm spot - started out as 2cm on 7am 1/13/21; by 10am 1/14/21 the area has grown to 5.5 cm.  Additionally, severe headache with medication and fatigue as expected.
DEAD; This spontaneous report received from a consumer (patient's son/daughter) via a company representative via social media (J and J Corporate) concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: mastectomy, chemotherapy, radiation, and cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown ) dose was not reported, 01 total, administered on 12-MAY-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 17-MAY-2021, the patient died from unknown cause of death. It was unknown whether autopsy performed. Reporter reported that, "J&J killed my mom with their vaccine. She went through A mastectomy, chemo and radiation during COVID. The day she was cleared of cancer 5/12/21 (my birthday), she got vaccinated so she could fly back home with me but she was dead 5 days later. Thanks J and J". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221149992- dead. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Information has been received from a licensed practical nurse concerning a 5 year old female with no pertinent medical history or drug allergies who, on 25-APR-2008, was vaccinated with a second dose of MMR II (lot# 656430/1305U) in the right thigh. Suspect vaccination administered on that same day included a dose of poliovirus vaccine inactivated (unspecified) in the right thigh. Concomitant vaccinations administered on that same day included a dose of VARIVAX in the left thigh and a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid in the left thigh. In 2008, post vaccination, the child developed cellulitis of the right thigh. The patient came into the physician's office for medical attention and was treated with AUGMENTIN. No labs or diagnostic studies were performed. The nurse stated that "the parent of the child has not called the office since then so the child must be recovered." There was no product quality complaint. Follow up information has been received on 01-Jul-2008 from a health professional who reported that a 5 year old female, who on 25-APR-2008, was vaccinated with MMR II (lot # 656430/1305U) SQ/LT at 10:30 am. On 30-APR-2008 the patient experienced right injection site swollen, size of quarter and right injection site red, size of quarter. At this time, it is unknown if the patient recovered. Additional information has been requested.
Head aches, pain on side of head and back of the lower head. Have been taking over the counter medication to control the head aches.
Information has been received from a medical assistant referring to a patient of unknown age and gender. On 02-AUG-2017, the patient administered an improperly stored dose of PROQUAD (dose, frequency and route unknown, lot # N012490, expiration date:17-OCT-2018) for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown)(dose, frequency, route, lot # and expiration date unknown,)which was used to reconstitute improperly stored PROQUAD. The temperature excursion was at 6 Fahrenheit degree to 14 Fahrenheit degree for 156 hours(incorrect product storage). The previous temperature excursion was 6 Fahrenheit degree to 14 Fahrenheit degree for 4 hours and 15 Fahrenheit degree to 46 Fahrenheit degree for 1 hour. Data logger was not involved. No adverse effect was reported. This case was cross referenced with case 1708USA003212.; Sender's Comments:  US-009507513-1708USA003212:
patient received pfizer vaccine on 2/26/2021 and a second dose Moderna on 4/5/2021 did not have a reaction
Macular Rash across abdomen and the back 3 days after vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH MACULAR (non-serious), 3 days after the suspect product(s) administration, outcome "recovered", described as "Macular Rash across abdomen and the back 3 days after vaccination". Therapeutic measures were not taken as a result of rash macular.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrowing airway, wheezing, cough, sore throat, fatigue, headache, body aches, shakes.
Cellulitis vs. local reaction around injection site (swelling, reddened), three days post injection. Keflex 125/tsp  tsp QID X 7d
still feels a bit off; Left eye still worries her in that it seems vision is blurry; Still feels tired and "off " not normal; Cheek felt like it was drooping; Painful to lie on it and to raise the arm; leg felt like it was paralyzed or numb; left eye felt like it was drooping; shoulder where she got the shot is still painful; headache for 3 days starting the day of the shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MONOPARESIS (leg felt like it was paralyzed or numb) in a female patient of an unknown age who received mRNA-1273 (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported adverse event.).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced HEADACHE (headache for 3 days starting the day of the shot). On 03-Apr-2021, the patient experienced MONOPARESIS (leg felt like it was paralyzed or numb) (seriousness criterion medically significant), OCULAR DISCOMFORT (left eye felt like it was drooping), PAIN IN EXTREMITY (Painful to lie on it and to raise the arm), FACIAL DISCOMFORT (Cheek felt like it was drooping) and VACCINATION SITE PAIN (shoulder where she got the shot is still painful). On 19-Apr-2021, the patient experienced MALAISE (still feels a bit off), VISION BLURRED (Left eye still worries her in that it seems vision is blurry) and FATIGUE (Still feels tired and "off " not normal). On 03-Apr-2021, MONOPARESIS (leg felt like it was paralyzed or numb), OCULAR DISCOMFORT (left eye felt like it was drooping) and FACIAL DISCOMFORT (Cheek felt like it was drooping) had resolved. On 04-Apr-2021, HEADACHE (headache for 3 days starting the day of the shot) had resolved. At the time of the report, MALAISE (still feels a bit off), PAIN IN EXTREMITY (Painful to lie on it and to raise the arm), VISION BLURRED (Left eye still worries her in that it seems vision is blurry), FATIGUE (Still feels tired and "off " not normal) and VACCINATION SITE PAIN (shoulder where she got the shot is still painful) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       The patient consulted an HCP and spoke to 2 other doctors who concur that the patient should not get the second shot until the patient has been checked out. The new primary has ordered new tests to see if the patient had a TIA or stroke after the shot.  Patient is waiting on a phone from the new HCP call to schedule the tests.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested.
pt recv 1st,2nd & third doses respectively; pt exp spasms of the rt shoulder & a feeling of being "dragged out";lab tests showed anti HBs less than 10;pt refused booster doses;10mar94 exp fatigue/pain;dec94 recovered;
Severe frontal headache behind eyes with light sensitivity; no vomiting or nausea, not throbbing.
patient reported that she has severe nerve pain/tingling sensation, burning in both arms, both feet have tingling/needle feeling with the feeling of pressure and swelling on feet, difficult to walk, lower back pain and buttocks, stabbing and numbness in feet as well, she feels light headed and have difficulty going to the bathroom, whole body feels off,  blurry vision