chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax & 12OCT98 & 3 days later 15OCT pt exp myalgia, fatigue, fever, joint pain (hip) & pain in the scrotum & could not walk;hosp w/WBC of 13,000 & nl sed rate;the following day pt was clinically fine & WBC dropped to 10,000;
breaking out in bumps on arms and legs; breaking out behind right knee real bad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (breaking out in bumps on arms and legs) and RASH (breaking out behind right knee real bad) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE RASH (breaking out in bumps on arms and legs) and RASH (breaking out behind right knee real bad). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of 1 dosage form and CORTISONE for Rash, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE RASH (breaking out in bumps on arms and legs) and RASH (breaking out behind right knee real bad) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications. On 06-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection, lot # M033214, expiry date 13-JUL-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source.  Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1611USA011831:
Information has been received from a nurse practitioner in her 30's with no medical history who in Dec 2001 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. Subsequently, in first 24 hours, at 3:00pm she experienced severe arm pain, low grade fever 99.0 and pain in right arm for three days. The pt made a full recovery. It was also reported that the pt was previously vaccinated with Pneumococcal 23v polysaccharide vaccine on an unspecified date. Additional information has been requested.
Right upper arm red and hard and warm (10cm size), rash on chest and upper abd itching.
Diarrhea 2 days after vaccine, vomiting times 1 and abdominal pain day of vaccine, macular rash on her back about 3 days after the vaccine that is resolving.  Patient still has lingering fatigue.
This spontaneous report as received from a medical assistant referring to a patients of unknown age and gender. No information was reported regarding the patients' medical history, concurrent conditions, concomitant medications, drug reactions, and allergies. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020) and ROTATEQ (lot number: N011648 and expiration date: 01-DEC-2018) (product storage error) for prophylaxis. The vaccines were exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Follow-up information was received from the medical assistant on 30-JAN-2018 regarding the temperature excursions of the vaccines. On 23rd of an unspecified month in 2017, 16-DEC-2017, 02-JAN-2018, and 03-JAN-2018, the vaccines of GARDASIL 9 were administered to unspecified number of patients. On 09-DEC-2017, the vaccines of GARDASIL 9 were exposed to temperature of 33.90 Fahrenheit for 15 minutes X 8 cycles, 120 minutes. Upon receipt of follow-up information it was determined that this case is now valid because patients identifiers were received. Follow up information has been received from a physician on 21-AUG-2018, referring to a 17 year old patient (gender not provided) who on 29-DEC-2017, was vaccinated with improperly stored dose of GARDASIL 9 lot number: N021475 and expiration date: 31-JAN-2020, (strength, dose, frequency and route of administration were not provided). The vaccine was exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported.; Sender's Comments: US-009507513-1801USA008060:
Pt admitted to hospital on 9/5/23 for thrombocytopenia from COVID vaccine and discharged on 9/11/23 from Hospital. Pt still getting blood work done weekly to check platelets and if they don't go down then pt will be put on meds.
Pt reported golf ball size painful knot left axilla evening of 12/24/2020.   Pt took 600mg of Ibuprofen for inflammation and pain and the knot decreased in size by 12/25/2020 evening.   Pt also reported profuse sweating evening of 12/24/2020, to the point of changing clothes in the middle of the night several times.  Symptoms subsided 12/25/2020 evening.    No visit to seek medical treatment was needed.
This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 27th December 2021, the patient received the 1st dose of Shingles vaccine. On 28th December 2021, 1 days after receiving Shingles vaccine, the patient experienced chills, general body pain and fever. On an unknown date, the outcome of the chills, general body pain and fever were recovered/resolved. It was unknown if the reporter considered the chills, general body pain and fever to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received first shot this past Monday and the next day patient had chills, body ache and fever for 2 days. They said it was just a few of the side effects. The follow-up would not possible as no contact details were available.
Patient was found unresponsive in back aisle of our store approximately 45 minutes after vaccination. Based on report from EMTs patient's condition was attributed to hypoglycemia. She was given glucose and was able to respond to commands but was still transport to medical facility
2 to 3 days after receiving the shot, patient starting experiencing pain in the left arm (arm that received the shot). Pain is localized to the area about 2 inches under where the injection occurred and does not radiate beyond the elbow or above the shoulder. The painful area is about 2 and 1/2 inches in diameter. The patient has been experiencing pain daily since then. He states that the pain is excruciating if he lifts his arm above the shoulder. If it is below the shoulder, the pain is not as bad - he describes it as a muscle soreness and achiness. If he applies pressure to the area, he has an increase in the pain. Pain is worse in the evening.
Patient complained of itchiness to lower legs and back when approached by RN observer. Dr. spoke with patient and verbal order for Zyrtec 10mg ordered, and given to patient at 2:27pm. 2:33pm, Patient stated she needed to go to the bathroom. RN followed a few minutes later with wheelchair due to patient's walking with cane, heat, and distance to the bathroom. Patient insisted on smoking prior to return to observation area, and smoked 2/3 of cigarette.  On return to observation area, patient stated she was getting dizzy and leaned against pillar. Patient instructed to get into wheelchair and was wheeled to Dr. for further orders. Vital signs were requested and obtained.  2:49pm 97% RA, HR 73, 155/83 (120) 2:52pm 97% RA, HR 70, 144/71 (97) 2:59pm 98% RA, HR 72, 147/82 (103)  Patient instructed to drink additional water. Dr. came back to assess patient and patient was cleared to go home. Patient able to ambulate on her own.
The middle of October, the vision in my right eye became blurry and itchy. At the end of October my right eye started hurting. I saw my ophthalmologist on 11/3/2022. She diagnosed as light herpes simplex dendric keratitis. It was a flare up. I had it before. The doctor mentioned that she seen other patients that had flare up. She was wondering if the COVID-19 vaccine caused viral infections to flare up. She gave me erythromycin in my right eye and valacyclovir to take instead of my acyclovir. She had me discontinue 2 of my eyedrops for now. I have a follow up with her on 11/17/2022. My right eye has improved, but it is not fully healed.
Patient had complaint of feeling faint/uneasy. initial heartrate estimated 90, warm flushed cheeks. After resting, heart rate remained at 80. After 30 minutes patient still felt uncomfortable, heart rate 80 but felt okay to drive home.
Patient received 2nd dose of Pfizer-BioNTech COVID-19 Vaccine EUA at 12:37pm on 1/27/21. Subsequently developed lightheadedness, shortness of breath, and throat swelling after 10 mins.  Clinic nurse administered EpiPen 0.3 mg IM dose x1 and activated Code Blue via nearby security guard. Patient was stabilized and escorted to ED for evaluation. In the ED, patient received another dose of epinephrine 0.5mg IM, methylprednisolone 125 mg IV, diphenhydramine 50 mg IV, and famotidine 20mg IV. Patient was then transferred to the CDU as compared to initial presentation patient felt improved. Patient was cleared to be discharged at 9pm.
Waking up at 02:00 on 01/08/21 with chills. all 4 extremities where shaking I was that cold.. temp of 100.4. weak.  stayed home from work. then on 01/09/21 I spent all day in bed as well. very tired. my arm was VERY painfull when touched or would try to use it.
Headache, Nausea Vomiting, fatigue Narrative: missed one day of work following second dose
Pt vax; exp h/a, fever for 3 days.  Given 2nd dose; exp h/a, fever, chills, & weakness which lasted for 4 days.
Joint pain, headaches, congestion, fever, chills, coughing, asthmatic symptoms.
low-grade flu symptoms; achiness; mainly tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (low-grade flu symptoms), MYALGIA (achiness) and FATIGUE (mainly tired) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (low-grade flu symptoms), MYALGIA (achiness) and FATIGUE (mainly tired). At the time of the report, INFLUENZA (low-grade flu symptoms), MYALGIA (achiness) and FATIGUE (mainly tired) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported.
Pneumonia; Cold; Fatigue; Pain in arm/Sore arm; This is a solicited report from the  based on the information received by Pfizer from (Mfr. Control No. : 21K-163-3861208-00).  A contactable consumer (patient) reported that a 39-year-old female patient received bnt162b2 (Pfizer Covid-19 Vaccine), intramuscular in Apr2021 (lot number unknown, expiration date unknown because the packaging was discarded) as single dose for Covid-19 Vaccination; adalimumab (HUMIRA), subcutaneous from 01Jan2020 (Batch/Lot number was not reported) to Apr2021, at unspecified dose for Moderate To Severe Rheumatoid Arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date with outcome of recovered, fatigue and pain in arm/sore arm in Apr2021 with outcome of recovered in Apr2021, and cold on an unspecified date (reported as 2020/2021) with outcome of recovered. The last action taken in response to the events for adalimumab was permanently withdrawn in Apr2021. COVID-19 Vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for Humira (Adalimumab): The reporter's causality for the events with Humira (Adalimumab) was no reasonable possibility.  Causality for bnt162b2 (Pfizer Covid-19 Vaccine): Not Reported  The reporter's assessment of the causal relationship of the events with the Pfizer suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on a compatible temporal association and known product safety profile, there was a reasonable possibility that the reported events of fatigue and pain in arm were related to BNT162B2 vaccine. The events pneumonia and cold are attributed to intercurrent medical conditions that were not related to BNT162B2 vaccine.
Tingly arm, down to finger tips. Had similar reaction with 1st COVID vaccine but it got better within 15 minutes. Arm still numb after 2 hours, fingers tingly. No feeling in arm. Capillary refill was good. Grip weaker on affected arm. Motor function is fine (she was typing on a keyboard). Called a day later to check on PT. Her whole arm is still numb, tingly feeling started coming back to her fingers about 6pm 5/20/21. Experienced other effects from the vaccine like fever, chills, shakes, and nausea.
Red, raised itchy skin around injection site.  At first  I thought it might be contact dermatitis from something on the bandaid, but it is larger than the bandaid was.  And then I remembered  reading about skin issues after shots, so I decided to report this.  It's not debilitating and I assume it will go away on its own, hopefully before my second shot on 3/31.
RIGHT ARM HURT THE NEXT MORNING.  LEFT ARM HURT THE 2nd MORNING.  A WEEK LATER MY BLOOD PRESSURE WENT UP ABOUT 40 POINTS  AND I WENT TO DR AND HE RAISED MY BLOOD PRESSURE DOSE. THEN BOTH MY KNEE JOINTS SWELLED FOR A WEEK. THE SWELLING LEFT MY KNEES AND WENT DOWN TO MY ANKLE BONES. IT HAS BEENOVER A MONTH AND I CAN BARELY WALK.
received Infanrix instead of Pediarix; received Infanrix at 23 months of age and Pediarix at 3 years old; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 5-year-old patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (1st dose received 2 months of age).   On an unknown date, the patient received Infanrix, Infanrix Pre-Filled Syringe Device, the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device and not applicable after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and drug dose administration interval too long. On an unknown date, the outcome of the wrong vaccine administered and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was 5 years and 10 months at the time of reporting. The patient received a dose of Infanrix instead of Pediarix, which led to wrong vaccine administered. The patient then received  a dose of Pediarix later then the recomended interval, which led to lengthening of vaccine schedule. The patient wanted to receive a dose of Kinrix to complete the schedule.  The reporter consented to follow up.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
This spontaneous report was received from a mother concerning her daughter of unknown age. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the patient received a dose of GARDASIL, (dose, route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. After vaccination, few days later, the patient developed lesions in or around her vagina. At the time of the report, the patient's outcome was unknown. The relatedness between suspect product and adverse event was not provided. Additional information is not expected.
Fatigue; Headache; Aching joints; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Aching joints) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Aching joints). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Aching joints) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported.
1 of 4 pts vaxed from the same DTP lot# who had adverse event;this pt recvd DTP/OPV/HIB/HEP B on 20OCT94;MD visit 21OCt-had fever 99.4, mild red nodule @ inj site;also had diarrhea & vomiting;no med prescribed;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history or concomitant medications. In 2015, the patient was administered ZOSTAVAX by a healthcare provider at a family medical center (dose, route, and lot # not provided). The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, the patient was treated by healthcare providers at a the same office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries.  As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages.  The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
On September 20, 2023 at about 12:15 PM, I received the 3 vaccines listed above at a pharmacy.  All 3 injections went smoothly.  I felt perfectly fine during the approximately 5 minutes I remained in pharmacy, and continued feeling fine getting into my car.  I started my 15 minute drive home.  About 5 minutes into the drive I started feeling somewhat light-headed, which within a minute or two progressed to very concerning light-headedness bordering on dizziness.  I didn't want to pull to the side of the highway, but knew I would have to if it got any worse.  I found myself purposely hyperventilating on and off to keep being able to drive.  This status continued the remaining 10 minutes to arrive home. I sat down at home.  Within about 3 minutes I noticed my symptoms start to lesson.  Within an hour I no longer felt light-headed at all.   In addition to being dangerous for driving, I consider this adverse event significant because I have never had any adverse reaction to any vaccine I have ever had.
The symptoms began 4 days ago. Symptoms have remained unchanged. The patient presents w/ chills, diarrhea, fatigue, fever, generalized weakness, headache, nausea and joint pain. The patient does not present with abdominal pain, anorexia, arthralgia, back pain, earache or vomiting. Patient had a response to medications (Tylenol) and a response to rest. The illness is associated with change in appetite and rash.
pt recvd vax 26JAN93 & same day pt exp arm soreness, nausea, h/a, vomiting; pt took Advil; awoke the following morning & again was nauseous & had a h/a;
This spontaneous report was received from a physician referring to a 16 year old male patient. The patient did not had any pertinent medical history, concurrent condition, drug reaction/allergy neither was taking any concomitant medications. On 12-JAN-2018, the patient was vaccinated with the first dose of his Human Papillomavirus (HPV) vaccination series with GARDASIL 9 lot # N007931, expiration date on 17-NOV-2019, for prophylaxis (strength, dose and route were not reported). On 13-JAN-2018, one day after vaccination, the patient developed 102°F fever. On this same date, the patient received a prescription for TAMIFLU 75 mg, 1 capsule, twice daily for 5 days. The physician reported that as of 16-JAN-2018, the patient had recovered from fever. The causality assessment between the fever and vaccination with GARDASIL 9 was not provided.
One day post vax pt was extremely fussy. The pt slept only 2 hours during the last 15 hours. Pt was treated with Motrin.
She received two doses of COVID Pfizer vaccines on 7/17/21 and 08/07/2021. She contacted facility where she had scheduled C section on 5/26/22 to notify that she has upper respiratory infection symptom and wondered she should come to have the surgery. She was asked to come to evaluate and have C-section as she was already 39 weeks. Her surgeon ordered COVID PCR, which resulted in positive and pursued C-section on the same day. No post-surgical complications were reported, and she was hemodynamically stable. She was discharged home on 5/28/22 without any specific treatment for COVID-19.
One hour after vaccine administration at 2;15pm client experienced fever 100.3oF progressed to bloody diarrhea X 3 and nausea with increasing fever to 102.4oF given Ibuprofen and by 7pm temperature down to 99oF no further diarrhea. next morning felt better with sore right arm no redness or swelling at injection sites.
8 Days after injection the arm became hot, red and tight at site  of injection.  I tool 2 Benadryl tablets and used cold compresses. Will see Primary Care physician or allergist if symptoms do not improve.  Moderna COVID-19 Vaccine EUA
Temp spike to 103. Febrile Seizure, EMS notified. Evaluated and not transported to hospital. Advised to follow up with MD in morning. Was very weak and very hot per parents. Eyes rolling in head and jerking x one minute. Received multiple vaccines last week.