chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 10:18 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:18 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The occupation of reporter was reported as clinic manager.  The age of the patient was reported as 60.30.  No concomitant medications were reported.  On 03-Apr-2021, 20 vials were moved to clinic.  The vial was initially moved to the fridge on 30-Mar-2021 and proposed beyond use date was 29-Apr-2021. On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit that has been reached by the vial. The vial was moved to clinic on 03-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  The healthcare professional (HCP) reported that, each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. The vial was stored in cooler storage during high-pace COVID-19 vaccination clinic at the time of excursion. Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
8 days post completion of the COVID-19 Pfizer 2 vaccine series, herpes zoster (shingles) outbreak began on the left forehead with ocular migraine and hypersensitivity of the left medial portion of the face. Valacyclovir 1000mg TID x10 days was initiated within 24 hours of onset, and rash continued to progress down the face to the left eyebrow, left nostril, and left upper lip. Pain and hypersensitivity of the left upper jaw and teeth began on day 3 of zoster outbreak, and ocular migraine increased in intensity. The rash began to blister on day 4, and is continuing to blister and weep currently (day 5).
About 30 minutes after receiving my first dose I began to feel extremely fatigued and weak, with a slight shortness of breath. Following that was intense nausea that lasted about 15 minutes followed by a migraine lasting through the next day.
15 minutes post vaccine pt had dry throat, tingling at back of throat. Symptoms progressed to c/o n/v.  Benadryl 50 mg by mouth given.
01/20/2022 patient given a 2.5mL instead of a second dose 0.5mL. Doctor notified at 5:11, and directed to notify patient of reduced dose administered. Patient informed to come to clinic to receive a 2nd dose of 2.5mL for a completed dose. Attempted to notify patient. Message left. Will continue to call patient to inform.
Left arm swelling, red, warm to the touch. Treated with antihistamines. Child with Factor IX deficiency - vaccine given Sub Q.
12/21/12 Tingling in toes. 12/22/12 Chest pressure and headache. 12/24/12 Tingling all over body. 12/28/12 to 12/29/12 Increased headache and chest pressure.  "Paralysed", unable to move x 20mins x 2. 1/2/13 urinary frequency and retention. Continues at present day with tingling and muscle weakness.
Information has been received from a physician and a health professional concerning the health care professional's 19 month old white son with no known drug allergies and no past medical history who on 7/6/01, at approx. 08:45, was vaccinated with a 1st dose of rubella virus vaccine live (second generation) (lot 630609/0410J). It was noted that the vaccine expired on 3/4/01. There was no concomitant medication. There was no illness at the time of vaccination. One month, post vax, the rubella IgG antibodies were done that were positive. On 7/16/01, the pt experienced a generalized rash over the entire body including the trunk, arms, legs and face. It was reported by the responsible physician that the "rash was unrelated to the shot". The child was afebrile. Unspecified medical attention was sought. Additional information has been requested. Follow up info from the physician indicated that the child was "doing fine" and did not have any ongoing problem related to the vaccination. It was noted that his rubella titers were adequate.
Pfizer vaccine has killed; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Pfizer vaccine has killed". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: Reporter was thinking about all the people that the Pfizer vaccine had killed including his dear wife of 50 years of marriage and he now will probably have to go into an assisted living home as he cannot take care of himself. Their management should be arrested and jailed for life or given the death penalty for all the thousands of others who have died because if their killing vaccine. Reporter considered event was caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pfizer vaccine has killed
Initial unsolicited misuse report received from a consumer on 03 Oct 2016. This case involves a two-month-old male patient (reported as 8 week old) who was vaccinated with a dose of PENTACEL, dose of ACTHIB, dose of IPOL, dose of DAPTACEL and ROTARIX (manufacturer- Merck) (batch number, expiry date, route, dose not reported for all vaccines) on 29 Sep 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) included no known allergy and concomitant medications were not provided. Illness at time of vaccination was reported as none. On 01 Oct 2016, two days following the vaccination, the patient began having periods of crying fussy, holding breath, "looks like in pain and shock" face red. On 02 Oct 2016, the patient was taken to emergency room and diagnosed with acid reflux. It was a case of extra dose administered. Lab data and corrective treatment was not reported. The patient was not recovered from the events. Upon internal review, the company decided to consider the event serious because of important medical event shock. List of documents held by sender: none. Sender's Comments: 2 month old patient experienced acid reflux, shock, holding breath and face red after vaccination with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE, HIB (PRP/T) VACCINE, IPV (VERO), DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE and ROTAVIRUS VACCINE. This case is suspected medication error case as patient was given extra doses of vaccines. Based on the information role of the vaccine can be excluded, because reported events can be due to extra doses administration or may be due to other etiology. However more details regarding relevant medical history, previous vaccination history, concomitant medication, concurrent condition at the time of vaccination are needed to complete assessment of the case.
About five minutes after receiving tetanus booster injection, I experienced nausea and broke out in a cold sweat.  I felt I might pass out for maybe five minutes, and then it all abated spontaneously.  Exactly the same thing happened to me ten years ago when I got my last tetanus booster.  I have no known allergies and have not experienced these symptoms in this way at any other time.  (I also had mild arm soreness a day later.)
8 days post vaccine where the injection was given in the upper right arm an area approximately 3 inches by 2 inches developed that was raised, red, inflamed and itchy. It is slightly painful to the touch. This appears to be consistent with the reports of COVID arm.
A report was received from a health care professional on 11/24/03 concerning a 63 year old female vaccinee who was inadvertently administered frozen Fluvirin vaccine on an unreported date. On unknown date, the vaccinee inadvertently received Fluvirin, which had been left adjacent to a freezer compartment and was subsequently frozen. The vaccinee will be advised to receive Fluvirin again in 3 weeks time. It was not reported if the vaccinee had experienced any adverse reaction. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Died after taking the second dose of the vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Died after taking the second dose of the vaccines". The patient date of death was unknown. The reported cause of death was "Died after taking the second dose of the vaccines". It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Died after taking the second dose of the vaccines
enlarged heart; arm tenderness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jun-2021 and was forwarded to Moderna on 28-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CARDIOMEGALY (enlarged heart) and PAIN IN EXTREMITY (arm tenderness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (triple bypass, performed two years ago.). Concurrent medical conditions included Osteoporosis (in left knee). Concomitant products included PARACETAMOL (TYLENOL) for Osteoporosis, CLOPIDOGREL, PAROXETINE, ATORVASTATIN, BUPROPION, LOSARTAN, AMLODIPINE BESILATE (AMLODIPINE BESYLATE 10), VITAMIN D2 and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm tenderness). On an unknown date, the patient experienced CARDIOMEGALY (enlarged heart). On 04-Feb-2021, PAIN IN EXTREMITY (arm tenderness) outcome was unknown. At the time of the report, CARDIOMEGALY (enlarged heart) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Echocardiogram: heart was slightly enlarged (abnormal) Heart was slightly enlarged.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that the patient was told by their doctor that their heart was slightly enlarged, per echocardiogram. The date of discovery was not provided. No treatment information was provided.   This case was linked to MOD-2021-239309 (Patient Link).
L arm injection site immediately with localized swelling and some redness ~ 2 to 3  cm in diameter. No other symptoms or complaints.  Monitored x 30 minutes.  Swelling and redness resolved after ~ 15 mins.
no additional AE reported; inadvertently administered an expired PNEUMOVAX 23; This spontaneous report as received from a pharmacist refers to a 72-year-old female patient. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapy were not reported.  On 19-AUG-2020, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # R033080, expiration date 06-JUN-2020, route of administration and anatomical location were not reported), for prophylaxis. The vaccine had no prior temperature excursions. No adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R033080; expirationdate: 06-JUN-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
rash provider has blood work broke out over arms on Tues 1/5 and spread to entire body within 24 hrs thereafter. exremely itchy and fatigued since symptoms arose.
Mom reports pt had seizure which she described as a"flutter."  States pt had 2 more siezures on 10/15/2010 (in the morning) and described those as "flutters" as well. States pt's last seizure was approx. 1 yr ago.
1/16/21 - 3:40 PM - Metallic taste in mouth 1/16/21 - 3:45 PM - Chills 1/16/21 - 3:50 PM - Neck / Back soreness  1/16/21 - 3:55 PM - Lightheadedness  1/16/21 - 6:45 PM Difficulty Breathing / Lung Pain, tiredness  1/17/21 - Arm / Body pain, difficulty sleeping, tiredness  1/18/21 - Arm / Body pain, difficulty sleeping, tiredness  1/19/21 - Full body aches, arm pain, lightheadedness, dizziness, tiredness
swelling to her right arm above her elbow, her right arm and it is 6 cm wider than her left arm; pain to her upper arm; Small, red, pin-point dots on her upper arm; Hurts to have anything, including light clothing, touch her skin; 1st dose more than six months ago, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (above right eyebrow) and pain. Concomitant products included valaciclovir hydrochloride (Valtrex).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and did not receive the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced swelling arm, pain in arm, erythema of extremities, touch sensitivity increased and incomplete course of vaccination. The patient was treated with trolamine salicylate (Aspercreme). On an unknown date, the outcome of the swelling arm, pain in arm, erythema of extremities and touch sensitivity increased were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the swelling arm, pain in arm, erythema of extremities and touch sensitivity increased to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-Oct-2022 Reporter's comment: The reporter was the patient.  The patient received Shingrix dose in her right deltoid.  She could not recall when exactly the dose was given but sometime within the past year and more than six months ago. Within about one month of the vaccine she experienced swelling to her right arm above her elbow.  Her doctor measured her right arm and it was 6 cm wider than her left arm.  She also experienced pain to her upper arm.  She described this pain as being similar to when she had shingles in the past.  It hurts to have anything, including light clothing, touch her skin.  She also noticed small, red, pin-point dots on her upper arm.  She had been treating the pain with Aspercreme, which temporarily helped her.  She had a follow up appointment with her doctor on Thursday. The reporter might follow up with patient.  There was no MD information provided. The consent to follow-up was requested. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Left deltoid injection site swollen, red and warm. Mother put alcohol on area, child also given Tylenol last night and 2 x today.
Body aches; Chills; Low grade fever; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02May2021 at 12:15 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medication within two weeks of vaccination. On 03May2021 at 02:00, the patient experienced body aches, chills and low-grade fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, chills and low-grade fever was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment(30AUG2021): This follow-up report is being submitted to amend previously reported information: Vaccine Facility Information added
Parents found pt at 5am (after he screamed) having a seizure. Pt has neurologic anomalies eval at ED -> febrile, otitis diagnosed. Child had four immunizations and SYNAGIS previous day.
I experienced terrible acid reflux overnight; I started having intractable hiccups; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Jul2021 at 16:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient had history of known allergies to penicillin (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 23Jul2021 at 19:00, 3 hours after the vaccine, the patient started having intractable hiccups that lasted over 48 hours. These hiccups lasted sometimes longer than an hour and provided may be a 30 minutes break before starting again. On 24Jul2021, the second night of sleep, the patient experienced terrible acid reflux overnight. The patient ate a healthy diet and could not remember the last time when he experienced acid reflux. The patient took digestive enzymes and went to sleep, the acid reflux was gone in the morning and so were the hiccups. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of acid reflux which included treatment with digestive enzymes, however no therapeutic measures were taken as a result of intractable hiccups. The clinical outcomes of event intractable hiccups and terrible acid reflux were recovered on 25Jul2021.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Case number PHEH2014US024966, is an initial spontaneous report from a nurse received on 09 DEC 2014. This report refers to a 56 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145701) intramuscularly at a dose of 0.5 ml on 20 NOV 2014. The  nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 OCT 2014 and the temperature was between 46 to 49 degree F during the excursion.
Right after I took the vaccine. I started having night terrors where I would wake dripping in sweat. The dreams consisted of being chased by like lizard-type creatures. When caught in the dream a microchip was planted under the skin.  I also what felt like high fever and chills. thought I  was going to die.  I think I got covid from the vaccine.  I refuse to take the second shot and this drug was rushed.
Received Aug 2021 and contracted Covid January 2022, lasted for a month and only saw doctor through video exam.
Localized erythema and pain at site of injection. No shortness of breath, chest pain, difficulty breathing. No fevers/chills.
Approximately 1 hour post vaccination, patient began having seizure like activity with repetitive movements and could not speak. Was breathing normally and making repetitive sounds.
patient received new comirnaty vaccine on 9/30 and stated that he has no memory of the time between 5pm on 9/30/23 and 3pm on 10/1/23.  he states that he remembers everything since around 3pm on 10/1/23 to our conversation around 12pm today, 10/2/23.  he did not report any other issues other than not being  able to remember that time period and feeling as though he was in a "blacked out state"
About little over a week (1/18/2022) after 3rd dose of moderna, I started experiencing chest pains, tightness, heaviness in the chest, very tired on days that symptoms are more prevelant. Feeling of high blood pressure, lightheaded, sometimes little dizzy. The symptoms also come in waves, some days its much lighter and some days its very painful to the point I feel shooting aches in other parts of the body. It is now over 7 weeks from vaccine and about 6 weeks from first symptoms and nothing is improving to the point I used to function.