chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of LIQUID PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse on 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to a female patient vaccinated with improperly stored RECOMBIVAX HB(lot# N011851 with expiration date 19-DEC-2019 ) on 27-SEP-2017. No adverse event was reported. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter(link reports: 1710USA004069, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593,  1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
Redness(2X4 inches), soreness, swelling, itching and hard lump in center.  Started feeling itchy 6/19/19 evening then redness started and began to spread 6/20/19  morning. She states it is now (6/21/19) approx 2x4 inches and has hard lump in the center. She denies any lesions or chickenpox-like rash. She states it "looks like a huge mosquito bite" She denies scratchy/itchy/tight throat or difficulty breathing.  Reported over the phone by patient, no physical exam  or treatment done.
pt recv vax 25OCT96 & same day pt devel splotched area that extended into underarm;pt was placed on ATB, & slowly began to get better;
No additional AEs; improperly stored vaccine was administered on 08/26/22.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. There was no information regarding, the patients drug reactions and allergies.  On 26-AUG-2022, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), injection, lot# T029522, expiration date 13-MAR-2023, (strength, dose, dose number, route and site of vaccination were not provided) for prophylaxis (product storage error). No additional adverse events (AEs) (no adverse event).  The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), underwent the temperature excursion of -39.8 Fahrenheit degrees (F) for 3 hours and 27 minutes. Previous temperature excursion was not occurred.
Mom describes uncontrolled crying, child was inconsolable for 7 days afterward. She had no fever or injection site reaction.
Information has been received from a registered nurse concerning her son-in-law, who had no medical history and allergies, whose daughter was vaccinated with a dose of Rotateq on approximately 01-FEB-2007. Concomitant vaccine administered on the same day included a dose of Pediarix. On approximately 03-FEB-2007, early in the morning, the father developed diarrhea and vomiting. He was seen by a family member who was a physician, and was placed on fluids. The diarrhea and vomiting continued for three days, and he missed one an half days of work. Most of his symptoms resolved within three days. It was noted that the father did not resume a regular diet until a week later. After a week he recovered completely. There were no laboratory or diagnostic test performed. No product quality complaint was involved. The patient's experienced were considered to be disabling by the reporter since her son-in-law missed work. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of vaccine administered at inappropriate site in a 12-hour-old male patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included IMMUNOGLOBULIN for prophylaxis. On 7th December 2021, the patient received Engerix B and IMMUNOGLOBULIN. On 7th December 2021, unknown after receiving Engerix B, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown. Additional details were provided as follows: The pharmacist reported that Engerix-B administered to an infant patient at 12 hours of age, then 4 hours later an immunoglobulin was administered at the same site, which led to vaccine administered at inappropriate site. No other adverse event information were available. The reporter consented to follow up.
Vertigo.  Unable to stand or walk or move my head for 7 days. Then only with debilitating nausea hand dizziness for 7 months. Had many tests done including Epley Maneuver to treat it. Eventually went away after 7 months. And then came back
Covid vaccine given outside 6 hour after diluent added. Health Director notified per RN. Health Director f/u and notified RN "vaccines within manufacture guidelines which make doses viable"
patient was given monovalent pfizer vaccine  but was supposed to receive the bivalent vaccine no complaints or issues post vaccine spoke to patient and is aware of the vaccine he received was monovalent Contacted patient primary care provider and  they will reach out to the patient.
Red, warm area at injection site. Approx 2" x 4 ". Gave BENADRYL 25mg q6 hours. No difficulty breathing, swallowing.
Constant chest pain, nausea, vomiting, trouble breathing, pounding heartbeat, headache, blurred vision, and dizziness.
patient's COVID-19 history.  In summary, this is a 90-year-old woman whose husband tested positive for COVID-19.  She was in close contact with him on 11/29/2021.  He was admitted to Hospital on 11/29/2021.
Chest pain, electric shocks in the whole body, pins and needles in legs,  heavy legs,  pressure in the head, headache, internal tremors, internal vibrations, feeling malaise .
Burning on the center of his back to his down right side of the shoulder; when he stands up feel a hot pain; back is hot at the touch; A spontaneous report was received from a consumer concerning a 75-years-old, male patient who experienced burning on the center of his back to his down right side of the shoulder, back is hot at the touch, pain and when he stands up feel a hot pain.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   On 07 Jan 2021, approximately seven days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 026L20] intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 13 Jan 2021, the patient started experiencing burning in the center of his back to his down right side shoulder. His shoulder is hot at the touch. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events burning on the center of his back to his down right side of the shoulder, back is hot at the touch, pain and when he stands up feel a hot pain was unknown.
I experienced post-menopausal bleeding for 2 months, as heavy (but typical, schedule-wise) periods after having been post-menopausal for years.
On April 23, 2021 I noticed extreme fatigue and sore muscles in my arms and legs when I woke up (5:30 a.m.). This lasted approximately 48 hours. I also noticed soreness in the injection site for around 72 hours. On April 5, 2021 I noticed some upper back pain occurring intermittently throughout the days. This is still occurring. After contacting my healthcare professional, she feels that it is a muscle pain and most likely not related to the vaccine.
6/10 pain upon injection that has worsened to Pain 9/10 in shoulder joint of left arm. Limited mobility of rom of joint. "Deadened arm" feeling. No treatment as of yet but recommended rest, ice, warm compress, NSAIDs visit to PCP.
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 10:58 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 10:58 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 50.61   Concomitant products were not provided.  On 24-May-2021 Excursion time were reported at 08:00 A.M and 09.00 am with  temperature as 35 and 35 degrees Fahrenheit, total doses given for the day was 39, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 18-May-2021 , vial was moved to clinic on 24-May-2021. 3 vials were sent to clinic. Vaccine BUD date was 17-Jun-2021.  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 Fisherbrand 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 on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Patient described extreme cold sensation, shivering, and chills which started within 10 minutes of receiving shot. Shortly thereafter patient began to have random jerky movements of both arms, shoulders and neck for approximately 2 hours. Symptoms subsided on their own w/o treatment.
Narrative:  Unclear if persistent/worsening transaminitis is due to patient's Hep B disease course alone or if any contributing factors due to receipt of COVID-19 vaccine (Pfizer) under EUA.
Follow up information has been received from a health professional concerning an 18 year old black female student, with no medical history on drug allergies, who on 05-JUL-2007 was vaccinated with her second dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccinations administered on that same day included the first dose of hepatitis A vaccine virus (inactive) (MSD) (Lot# 656966/0018U) in the right arm, the first dose of GARDASIL vaccine (yeast) (MSD) (Lot# 657868/0523U) in the right thigh, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (AC52B005CA) in the right arm and the first dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (Lot# U2327AA) in the left thigh. There was no illness at the time of vaccination. On that same day, the patient developed a local reaction with 4.5 x 3.5 cm injection site swelling and 4.5 x 3.5 cm redness (left arm). It was also noted that the patient also developed zoster after vaccine earlier in life. It was unknown whether medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
1st set of shots given on 8-31-06.  No fever or fussiness after shots.  9-6-06 Runny stuffy nose - Rx. Infant Pediacare .4cc given 3 times a day.  9-10-06 Lt arm jerking, fist clenched arm against body Lasted 3 to 4 minutes. Then arm went limp.  Cried only when arm jerking.  Arm remained limp for about 1 hour. No hand grasp at that time.  After 2 hours hand grasp returned and appeared normal.  9-23-06  Lt arm jerking with fist clenched.  Lasted 2 minutes.  Then limpness.  Regained normal range of motion and hand grasp after about 35 minutes.  9-28-06  Had been napping for 20 minutes.  Cried out.  Eyes closed. Lt arm jerking with hand clenched.  Arm close to body.  Lasted 2 minutes and arm again went limp for about 35 minutes.  9-29-06  Seizure began 8:10am.  Began in Rt arm as a tremor then moved into both arms and legs and then her whole body was shaking.  Eyes deviated to the lt.  No vomiting. Discharged on Keppra 70 mg twice a day for 5 days then 100mg twice a day DC DX: Status epilepticus, resolved. Epilepsy vs seizure disorder. Serious infection ruled out. PMH: Three episodes of left elbow to hand jerking three times this month. Jerking lasts two minutes, the arm is really stiff, she cannnot open the fingers and then the arm would go limp. Arm stiffness began ten days afer her 2 month old shots which were approximately three weeks prior to this ER visit. Mother did not make an appointment with neurologists that was recommended on 10/10/06.
Itching all over body; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. In October 2021, 20 min after receiving Shingrix, the patient experienced pruritus. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the pruritus was recovered/resolved.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received his first dose of Shingrix into the muscle of his upper right arm. Twenty minutes after the injection, he reported that he started itching all over his body. After taking Benadryl 50mg every 6 hours for 2-3 days, the itching resolved. The reporter consented to follow up with himself and his healthcare professional but could not provide full demographics.
Started with facial tingling, throat tightness, headache and abdominal pain. The symptoms decreased with single dose diphenhydramine and prednisone administration. Symptoms have waxed and waned for 3 days since. Now with lip swelling
Hep #3 vaccine administered 12 days after Hep #2 was administered.  NO adverse effects noted or reported.
extreme dizziness/vertigo 15 minutes after administration of the second shot on 7/19/21. felt better by the end of the day but mild dizziness persisted and sore throat and metallic taste appeared. On 8/7/21 the symptoms worsened to the point I couldn't go back to work. Saw my HCP on 8/12/21.  Labs normal. Today is the end of the 4th week after my first dose of vaccination and symptoms are still present: dizziness/vertigo/metallic taste/face tingling.
Information has been received from a nurse, for GARDASIL, a Pregnancy Registry product, concerning a pregnant female patient who on an unspecified date in 2009 ("in the last couple weeks") was accidentally vaccinated with a 0.5ml dose of GARDASIL instead of flu vaccines. It was reported that the nurse had reached into her diebold dispenser to retrieve the flu vaccines syringes, but took out GARDASIL filled syringe instead. No adverse effect was reported. Unspecified medical attention was sought. It was unspecified which trimester the patient was in. This is one of several reports from the same source. No further information is available.
This case was reported by a healthcare professional to a sales representative and described the occurrence of swelling at the injection site in a 18-month-old subject of unspecified gender who was vaccinated with Infanrix for prophylaxis. On an unspecified date the subject received unspecified dose of Infanrix (unknown). At an unspecified time after vaccination with Infanrix, the subject experienced swelling injection site and injection site discomfort. At the time of reporting the outcome of the events was unspecified. These events occurred in three different subjects. It was reported that one of the subject's arms looked like it could have been drained due to the swelling. The swelling area was also described as similar to the palm of the hand. Follow-up was received from the healthcare professional on 27 November 2007. The subject was a 4 year-old female. On an unspecified date, the subject received a dose of Pediarix ass the 5th "catch-up" dose at an unspecified site of administration. On 30 October 2007, at an unspecified time after administration of Pediarix, the subject experienced injection site swelling, injection site discomfort and cellulitis. The subject was treated with Bactrim and the events improved on 31 October 2007. The healthcare professional considered the events to possibly be related to vaccination with Pediarix. Comment: Cellulitis was assessed as medically serious.
Case number PHEH2014US013405 is an initial spontaneous report received from a medical assistant on 03 Jul 2014. This report refers tot an 11-year-old female patient. Her medical history and concomitant medications was not reported. She received only Men A lyophilized conjugate component of MENVEO (batch number: M13015), intramuscularly reconstituted with a sterile diluent instead of MenCYW-135 liquid component on 01 Jul 2014. No adverse reaction reported following this administration error.
April 1 - first dose May 7 - second dose  May 8 - Headache, muscle soreness, fatigue May 17 - I thought I had a headache (I don't ever get headaches)... As the day progressed, I became incredibly dizzy and had to get on all fours at some points due to the dizziness.  I was told by provider that I was experiencing vertigo. May 18 - continued to experience vertigo symptoms.  May 19 - continued to experience vertigo symptoms, but less than the 2 previous days May 20 - mild dizziness  May 21 - no more dizziness
Fever of 102, entire arm swelling, redness. Patient was given Keflex.
Vomiting starting 6 hours after vaccine (PENTACEL) then fever (103). pt had rectal supp of TYLENOL during nt and given 3/4 tsp MOTRIN in office.
kept him in bed all day long; dizziness; headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BEDRIDDEN (kept him in bed all day long), DIZZINESS (dizziness) and HEADACHE (headache) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In February 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In April 2023, the patient experienced BEDRIDDEN (kept him in bed all day long), DIZZINESS (dizziness) and HEADACHE (headache). At the time of the report, BEDRIDDEN (kept him in bed all day long), DIZZINESS (dizziness) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Normal, patient had seen many doctors and they had carried out a large number of tests and they come out normal.         Concomitant product use was not provided by the reporter.  It was reported that on the exact day of reporter's birth day patient had symptoms of headache and dizziness, and went to emergency room and the doctor could not find any problems, the headache and dizziness happens 24 hours a day that keeps him in bed all day long, he was a healthy man, until a few months ago he worked, he could not anymore, patient had seen many doctors and they had carried out a large number of tests and they come out normal. Patient suspected event occurred due to the booster because after that he had felt very bad.  Treatment information was not provided.
I developed nose bleeds after taking COVID shot and saw on the news that I?m the vaccine could cause thrombocytopenia. I had my doctor order a CBC on 2/17 and platelets came back at 89.  I did have a past history of thrombocytopenia throughout my pregnancy from 07/2019-01/2020.  Thrombocytopenia went away after delivering my baby and I haven?t had an issue since. Last CBC was 10/16/20 and at that time platelets were 156. Last abnormal platelet level was on 1/9/20 and level was 132.  As of now Dr. is monitoring me and will have me repeat CBC in 2 weeks.
This is a spontaneous report from a contactable physician from Pfizer Medical Information. A 4-month-old patient received PREVNAR 13 via an unspecified route of administration on an unknown date. Relevant medical history and concomitant medications were not provided. On an unspecified date 24 hours after vaccination, the patient experienced irritability, fever, and bulged fontanelle. As a result, the patient was taken to the emergency room for evaluation. The physician suggested a lumbar puncture; however, the patient's family refused. The patient subsequently left the emergency room. Evaluation confirmed that the events were a vaccine reaction. The outcomes of the events, irritability, fever, and bulged fontanelle, were recovering.