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 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 4:23 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 4:23 PM, 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 69.49.  No concomitant medications were reported.  Batch number 031A21A administered on 20-Mar-2021 underwent temperature excursion with temperature range 34 to 37 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34  or 35 degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.
4 patients were administered from a vaccine that experienced a temperature excursion; 4 patients were administered from a vaccine that experienced a temperature excursion; This spontaneous case was reported by a physician and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (4 patients were administered from a vaccine that experienced a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (4 patients were administered from a vaccine that experienced a temperature excursion) in a 40-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (4 patients were administered from a vaccine that experienced a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (4 patients were administered from a vaccine that experienced a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (4 patients were administered from a vaccine that experienced a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (4 patients were administered from a vaccine that experienced a temperature excursion) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. This case was linked to MOD-2022-541803 (Patient Link).
A physician reported that a 10 month old female, adopted from China in June, 2000, received Prevnar, Acel-Imune, Hib-Titer, IPV (Aventis Pasteur SA) and Engerix-B (SKB) vaccines on 6/19/00. Within 24 hours, she developed a fever of 103F to 104F. The fever was treated with acetaminophen and ibuprofen and persisted until 6/26/00. On 6/27/00, her temperature was 100F. The fever resolved on 6/28/00. On 6/25/00, she developed a generalized, maculopapular rash. The rash persisted as of 6/27/00. The pt was seen by the physician on 6/27/00. The infant recovered by 7/11/00.
This spontaneous report as received from a certified medical assistant refers to a 8 months old patient of unknown gender. On 02-JAN-2014 the patient was vaccinated with the first unspecified dose of COMVAX (lot number and expiration date not reported). On 05-MAY-2014 the patient was vaccinated with a second unspecified doses of RECOMBIVAX HB (lot number and expiration date not reported) and PEDVAXHIB (lot number and expiration date not reported) at the same time (instead of COMVAX. A third dose was not administered yet. No adverse events reported. Additional information has been requested.
2 days after Hep A vaccination, pt seen in ER for hives all over body - mom states ER dr said Hep A shot caused it. Script for steroid given.
swelling at injection site; muscle pain; fever; headache; shivering; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th August 2021, the patient received the 1st dose of Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced injection site swelling, muscle pain, headache, shivering and upset stomach. On an unknown date, the patient experienced fever. On an unknown date, the outcome of the injection site swelling, muscle pain, fever, headache, shivering and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, muscle pain, fever, headache, shivering and upset stomach to be related to Shingrix.  Additional case details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got her 1st Shingrix shot on Sunday.  The patient developed swelling at injection site, muscle pain, headache, shivering, upset stomach and fever, which had not resolved. The reporter did not consent to follow-up.
Most of left upper arm swollen, hot to the touch, painful to the touch, hurts to move, redness spreading over last 3 days
Information has been received from a RN nurse concerning a 14 month old female with no pertinent medical history and no drug reactions/allergies who on the morning of 06Jul06 was vaccinated SC with a 0.5mL dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot 649758/0382R). Concomitant therapy that morning included a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) and a dose of Hib conj vaccine (manf unk). There were no other concomitant medications. On 06Jul06, late at night, the pt was rushed to the ER with a febrile seizure and a ruptured eardrum. The child was admitted overnight, and intervention was unk. The pt has since recovered. The reporter would like a lot check for measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot 649758/0382R). The events were considered to be other important medical events by the reporter (OMIC). Additional information has been requested.
Patient  received his second dose of Moderna.  The patient did mention that he had a reaction of his tongue swelling on his first dose, but took Claritin per his PCP.  Staff instructed him that he would have a 30 minute observation time due to his history of immunization reactions and sulfa and various food allergies. During observation, the patient got the attention  to let him know that he felt his tongue swelling. EMS was activated along with the first set of vitals being taken. The vital signs are as follows: 1645 - 150/100  HR 87 RR 18  O2 97 1655 - 140/95 HR 89 RR 16 O2 93  1705 - 138/83 HR 88 RR 16 02 93 1715 - 135/80 HR 83 RR 14 02 97  As EMS was arriving he stated that he still felt his tongue was swollen, but denied difficulty breathing or worsening symptoms. In the EMS assessment, patient was monitored via a 12 lead which yielded sinus rhythm.  Patient declined transport to the hospital via EMS as he was alert and oriented x 3. Patient was advised to contact his PCP about the reaction to his second dose. RN instructed the patient to contact 911 if there is shortness of breath, difficulty breathing, and any other sign of distress
A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events diarrhea. The patient's medical history was not provided. No relevant concomitant medications were reported. On 1 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 10 Feb 2021, the patient experienced the event, diarrhea. Treatment details included Pepto-Bismol tablet. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, diarrhea was unknown.
Breakthrough case admission after 2 vaccines  Moderna 3/8/21 lot# 037K20A;  Moderna 4/9/21 lot# 027L20A
This spontaneous report as received from a medical assistant refers to an adult patient of unknown age. The patient was vaccinated with an expired dose of MMR II (lot # 1089Z exp date 24-AUG-2012) (dose and route not reported) on 11-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The medical assistant mentioned that the patient said he received MMR II as a child but did not know the total number of doses. Because the patient's past vaccination record was unavailable the physician decided to give him one dose of MMR II (which was the expired dose). No symptoms were reported. Additional information is not expected.
Loss of Appetite; Chills; Fatigue / Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of Appetite), CHILLS (Chills) and FATIGUE (Fatigue / Exhaustion) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DECREASED APPETITE (Loss of Appetite), CHILLS (Chills) and FATIGUE (Fatigue / Exhaustion). On 28-Feb-2021, DECREASED APPETITE (Loss of Appetite), CHILLS (Chills) and FATIGUE (Fatigue / Exhaustion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.
Asthma symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma symptoms) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     medical history of patient was not provided by the reporter.     On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced ASTHMA (Asthma symptoms) (seriousness criterion hospitalization). On 23-Apr-2021, ASTHMA (Asthma symptoms) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing was delayed on an unknown date.       No treatment information was provided.; 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.
2 year old patient inadvertently received PROQUAD and VARlVAX on a same day instead of MMR II and VARlVAX; received PROQUAD and VARlVAX on a same day; This spontaneous report was received from a medical assistant and refers to a 2 years old patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 25-JAN-2021, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 1 dose (formulation, exact dose, route of administration, anatomical location, lot # and expiration date were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) (formulation, exact dose, route of administration, anatomical location, lot # and expiration date were not reported) both for prophylaxis, on the same day instead of virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) (wrong product administered and accidental overdose). No further information was available.
I ha e Follicular cancer and was almost in remission I have not had a treatment in over 3 years . Since the vaccine my cancer has co.e back worse than ever before . Now I must do more treatment and my life is in the balence
I had a slight cough that Monday and I started to wonder if I was getting sick. It started with a sore throat, and I was tired and achy. I really didn't have much more than that. I contacted the doctor office on Tuesday November 29, 2022, after testing positive using a home COVID-19 test. I was not prescribed any medications and I was advised to remain quarantined. I called the doctor again because I was still testing positive. I was still symptomatic, but I still had a scratchy sore throat. I also had some lingering congestion. I was advised to continue to take over the counter medications for any symptoms I had remaining. It took about 14 days to get better. I got sick again in January with a cold again which lasted for about 2 weeks as well. I went to the doctor, and they tested for COVID-19 and the Flu. Both were negative.
Patient reported dizziness, assessment completed,  vitals taken SBP noted to be elevated. Symptoms of resolved SBP decreased after it was taken a second time. Patient referred to PCP for evaluation for further elevated blood pressure evaluation.
an unusual high pithced cry, could not lie down on back most likely to have been caused by screaming & obtained excessive amt of air; no fever; no vomiting; settled down p/taking pt APAP 4-5 hrs later;
Presented to ED on 11/9/21  Has had some nausea and decreased p.o. intake.  Also had an episode of diarrhea.  Was coming to the hospital to get some shots in his abdomen when he got lightheaded and was eased to the ground.  Denies striking his head.  He was actually coming to the hospital to get monoclonal antibody cocktail. No chest pain, sob, diaphoresis, or swelling/pain of lower extremity. Nothing makes better or worse except as previously mentioned. The course is variable. No radiation of pain. Denies pain/trauma to head, neck, back, chest, or abd/pelvis.
Nurse administered Pfizer vaccine into patients left deltoid. Dose leaked out from syringe tip no Dose noted as administered. Clinical supervisor informed of incident, pharmacy coordinator  informed of incident. Vaccine re-administration advised. Patient father requested different nurse. Pfizer Re- administered into Right Deltoid  to initiate their series of Pfizer vaccination. Vaccination complete no signs and symptoms of distress. Patient and parent in monitoring with no further questions or concerns. Incident reports filled out.
Information has been received from a RN concerning a 21 y/o female pt with no relevant medical history who on 28Jan1999 and 11Mar1999 received a first and second dose of varicella virus vaccine live (lot number unk), respectively. There was no illness at the time of vaccination. There was not concomitant medication. On 21Apr2003, a titer for varicella was completed and results were negative (results previously reported as "no immunity". It was also noted that there were no "problems" with the vaccine and no side effects. Unspecified medical attention was sought. No further information is expected.
This spontaneous report as received from a registered nurse refers to a college age patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in approximately May 2018 (reported as "month ago"), the patient was vaccinated with first dose of M-M-R II, subcutaneously (lot number and expiration date not provided) for prophylaxis. On 13-JUN-2018, the patient was vaccinated with second dose of M-M-R II, subcutaneously (lot number and expiration date not provided) for prophylaxis. On an unspecified date in 2018, the patient had negative test results for Measles, Mumps and Rubella antibodies. No adverse effects were reported.
Base on data submitted in database and related registries . Patient received expired COVID -19 vaccine dose .
Loss of oxygen, lymph nodes under arm of injection site, shoulder, chest, under ribs and in groins. Lethargic, was put on oxygen by healthcare professional.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EM9809), in left arm and on 05Mar2021 as dose 2, single (Lot number: EN6203) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 19Nov2021 at 17:15 as dose 3 (booster), single (Lot number: 035C21A), in left arm for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; HCTZ.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid (Lot number: FX8133) from 01May2022 to 06May2022.   Clinical course: And there was Rebound COVID Symptoms started on 12May2022 at 06:00 and patient was recovering. The patient had no Known allergies.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
On 11/20/2001 Husband states began with rash on the chest, spread to entire body. Wife complained of dizziness, itching and nausea. No medication was taken. Client didn't seek other medical attention.
Redness at site of varicella vaccine. Red inflammed area slightly medial to midline with small hematoma at site of injection. No tenderness to palpation. Good femoral pulse in right leg and good perfusion to RLE. Iced immediately, 2 tsp of BENADRYL given in office and child observed for 30-40 min.
Patient with diarrhea post vaccine. Within 24 hours developed sensation of needing to "remember to take a deep breath." She denies SOB/DOE/Oral swelling/Throat sensation
body aches / could not move her body because of the body aches; chills; nausea; could not sleep; could not move body; This case was reported by a nurse via call center representative and described the occurrence of general body pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included exposure to communicable disease (patient was exposed to tuberculosis).   On 18th February 2020, the patient received Shingrix (intramuscular). In February 2020, less than a week after receiving Shingrix, the patient experienced general body pain, chills, nausea, difficulty sleeping and mobility decreased. On an unknown date, the outcome of the general body pain was not recovered/not resolved and the outcome of the chills, nausea, difficulty sleeping and mobility decreased were recovering/resolving.   It was unknown if the reporter considered the general body pain, chills, nausea, difficulty sleeping and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right deltoid. The patient experienced body aches, chills, nausea, could not move her body because of the body aches and for two days, and she could not sleep. On 21st February 2020, the patient feeling much better, but she continued to experience body aches. The patient was exposed to a patient who had tuberculosis and would like to get herself tested for tuberculosis. The reporter consented to follow up.
The pt developed arthralgias and fatigue and was seen by his physician in July 1998. Treatment and outcome were not provided.
3/30/03 4 PM Temp 102.5 rectal, very cranky, crying. No rash, no otitis.
Severe swelling on entire upper arm from shoulder to elbow, hot to touch, painful to move arm at all.
This case was reported by a consumer and described the occurrence of adverse event in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. Day before reporting, the patient had all the listed side effects (adverse event) from SHINGRIX vaccine except upset stomach. The patient asked how long could she expect to experience the effects.
Information has been received from a physician concerning a 12 month old female with no allergies or pertinent medical history, who "this past week", on approximately 04 Oct 2006 was vaccinated SC with a 0.5 ml dose of Proquad (lot # 654041/0662F). Concomitant vaccination included influenza virus vaccine (unspecifed) (manufacturer unknown). Subsequently, on the same day, the patient experienced a "local reaction at the injection site while she was in the office". Medical attention was sought and the patient received Benadryl. Subsequently, the patient recovered. No further information was available. There was no product quality complaint involved. The patient receiving Benadryl for an injection site reaction, was considered to be an other important medical event. Additional information has been requested.
Information has been received from a healthcare worker (immunization official) referring to a 13 old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 24-AUG-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # K026387(expiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.