chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 11:26 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) 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 56.56.    Concomitant products were not provided.    On 14-FEB-2021, Excursion time was 09 AM, temperature was 32, at 10 AM temperature was 32, at 11 AM temperature was 32, at 02 PM temperature was 35 and at 03 PM temperature was 35 total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-FEB-2021, vial was moved to clinic on 13-JAN-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-MAR-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 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 in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.    Treatment medications were not reported.
Slowly started with slight headache and pain in the shoulder of injection sight. Pain and stiffness in the neck and in upper spine worsened over last 3 days. Second day after injection started feeling very fatigued and nauseous. Today neck and chest feels very stiff. Feeling fatigued with muscle weakness also with occasional rapid heart beat, some confusion, feeling tired, sensitive to light, on the verge of vomiting. Tightness in chest is worsening, lightheaded and dizzy. Anxiety attack occurred today followed by shaking muscles and trembling. no fever. Pain in neck and upper back worsened.
Report of 12 pts who were non-responders; addtl info has been requested;
She tested positive for Covid-19 after receiving the second dose in Apr2021; She tested positive for Covid-19 after receiving the second dose in Apr2021; This is a spontaneous report from Pfizer-sponsored program. This report was also received from Product Quality Complaint. A contactable consumer (patient) reported that a 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 02Apr2021 (Batch/Lot Number: ER8732) as dose 1, single; then via an unspecified route of administration, administered in left arm on 25Apr2021 (Batch/Lot Number: EW0169) as dose 2, single for COVID-19 immunisation. The patient has no medical history and no concomitant medications. Family history included her dad had heart attack at age 41. There were no additional vaccines administered on the same date of the Pfizer vaccine. No other vaccines were given within four weeks prior to the first administration date of the suspect vaccine. The patient tested positive for COVID-19 on 14Aug2021 after receiving the second dose. She believes it is because of her grandkids. She is on her 10th day of quarantine. The events did not require a visit to emergency room and physician office. The outcome of the events was unknown. The Product Quality Complaints Group concluded that the complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0169 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EW0169, fill lot EP8700, and the bulk formulated drug product EP8602. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
febrile-106 @ home given APAP & cool bath, brought to office-temp 103.2;
This spontaneous report as received from a nurse refers to a patient of an unknown age and gender. The patient's medical history, concurrent condition and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD lot# N034561, expiration date: 03-JUN-2019 or lot# N025926, expiration date: 18-MAR-2019 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent (MERCK) for prophylaxis. Administered dose of vaccine experienced the temperature excursion between -14 degrees Celsius to -10 degrees Celsius (also reported as -10.4 degrees Celsius) for 1 hour and 3 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse events were reported. This is one of four reports received from the same reporter. Lot numbers N034561 and N025926 have been verified to be valid lot numbers for measles, mumps, rubella and varicella (oka-merck) virus vaccine live with albumin status rHA. Sender's Comments: US-009507513-1806USA004464: US-009507513-1806USA004465: US-009507513-1806USA001112.
I had reactive arthritis and it moved from one part of my hand to my shoulder and to the other shoulder and to the other hand. That took a couple of days. I never had anything like that before. The next trip I took, I had exercise intolerance. It made me physically sick when I worked with my mom in her garden. It made my mind more cloudy. It was more difficult to find words. It was very difficult to type my feelings. My thyroid hormones got a little out of whack and an ultrasound showed nodules on my thyroid. I lost weight. Migraines were difficult to get rid of. TM joint was inflamed. I think that was bad about causing headaches. Those kind of things kept going. The arthritis traveling stuff still traveled but it didn't take 2 days to finish traveling. My word finding ability got better. It exasperated and caused all kinds of symptoms of my fibromyalgia. My skin turned from oily to dry. Basically, just the arthritis has been getting better but I still have arthritis in my shoulders like I've never had before.
Patient called 1-28-18 starting around 5pm on 1/27/18 his throat was swelling (he could breath and swallow a little) and his eyes became blood shot/sandy feeling in eye. Around 7pm he reports cold chills and feeling sleepy fever approximately 99.5. When he woke up in morning he was feeling a little better but eyes still feel same and throat swollen some.
Diarrhea; Swelling - Near Injection site; Arm Pain - Near Injection Site; Chills; Fever - Temperature of 100.0F; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Swelling - Near Injection site), VACCINATION SITE PAIN (Arm Pain - Near Injection Site), CHILLS (Chills) and PYREXIA (Fever - Temperature of 100.0F) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Swelling - Near Injection site), VACCINATION SITE PAIN (Arm Pain - Near Injection Site), CHILLS (Chills) and PYREXIA (Fever - Temperature of 100.0F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Swelling - Near Injection site), VACCINATION SITE PAIN (Arm Pain - Near Injection Site), CHILLS (Chills) and PYREXIA (Fever - Temperature of 100.0F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 100.0 (High) Fever 100.0 F.         No concomitant medications were provided by the reporter.
Patient had 3 seizures in the 2 hours after vaccine. He does have a known seizure disorder and he required no other medication to stop the 1 to 3 minute seizures. His office visit was prolonged by 2 hours.
A non-serious spontaneous report of "we gave expired H1N1 to several patients" was received from a registered nurse/health professional concerning a 47-month-old male out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date was 12-Feb-2010, that had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
pt recv vax 915AM & began high pitched crying @ 12noon & cried inconsolably for 3hr;MD notified & incident noted in chart;
after 24 hours . i experienced a low grade fever of 99.2. .severe headache that has lasted 2 weeks, pain  at the injection site, body aches, moderate stomach pain for 2 weeks., lack of appetite for 2 weeks
Pain in L arm immediately after the first Moderna Covid 19 injection. Initially, the pain was mild. After the second dose, the pain increased. The pain is not constant, but it is persistent. It occurs when moving arm up or to the side and when exerting pressure from the arm muscle. It impedes the ability of the patient to dress without assistance. The pain is in the upper arm and radiates downward. The patient has seen her primary care provider and an orthopedic physician, neither of whom could provide a correct diagnosis or treatment. The pain still continues after 10 months.  In addition to and more alarming than the arm pain, the patient was rushed to the ER on 10/05/2021 and diagnosed with a DVT in the L calf and bilateral pulmonary emboli, requiring hospitalization, rehabilitation, and continued medical care, including prescription blood thinning medication.  The patient had no known risk factors for these conditions.
Two minutes after receive the Covid 19 Vaccine 1st Dosage by Pfizer  my vision has been blurry. My vision has continued to be blurry and it is now 13 days later.
SWELLING AND REDNESS OF THE INJECTION SITE. PAIN AT THE INJECTION SITE. SWELLING AND PAIN GOING DOWN. PATIENT RECOVERING.
received vaccine on 31-Mar-2022 which was expired on 24-Mar-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine on 31-Mar-2022 which was expired on 24-Mar-2022) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine on 31-Mar-2022 which was expired on 24-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received vaccine on 31-Mar-2022 which was expired on 24-Mar-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.  HCP mentioned that there was incident because of miscommunication as a coworker told that there were some lot number whose expirations dates has extended.
After 01/05/2022 in the morning I had a bad headache, painful joints and muscles, fever of 102. Urgency of going to the bathroom. I had rash all over my body. I took Advil for 3 days. Friday morning I started feeling better.
allergic reactions to shot. skin conditions, went to allergist  pt. has epilepsy.  covid shot reacted with patient 5 days afterwards
PATIENT CAREGIVER CALLED AND REPORTED THAT FEVER, CHILLS, UPSET STOMACH, AND GENERAL UNPLEASANT FEELING WAS EXPERIENCED WHEN NO ADVERSE EVENTS WERE EXPERIENCED WITH THE FIRST DOSE.
vaccine expired on 29-May-2020 and administered on 01 and 08 June with no adverse event; Initial information regarding this unsolicited valid non-serious case recieved on 08-Jun-2020 from a non-health care professional (Office staff).  This case involves a patient of unknown demographics who was vaccinated with expired vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].   Medical history and concomitant medication were not reported.   On 01-Jun-2020 and 08-Jun-2020, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Lot number not reported, Expiration date- 29-May-2020) via unknown route in unknown administration site.   It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a registered nurse regarding a 4 month old patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 11-OCT-2017, the patient was administered an expired dose of ROTATEQ oral liquid (lot number L008057, expiration date 01-DEC-2016) for prophylaxis. No adverse effects were reported.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2014, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Day 1 - Fatigue beginning about 6pm, then foggy feeling about 7pm, then mildly headachy about 8pm Day 2 - Fatigue, fog, and headachy continued through the day easing somewhat in evening Day 3 - pretty much back to square
I suffered  focal and petit mal seizures within 24 hours of receiving the vaccine. I lost consciousness for about 2 minutes. I have had recurring migraines and seizures since the vaccination requiring hospitalizations and multiple  EEG's. I have been  seen by two neurologists for this issue.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 27-FEB-2012 the patient was vaccinated with the first dose of 0.5ml GARDASIL (lot number unspecified) intramuscularly. The patient was in office today, on 21-FEB-2013, to receive second dose of 0.5ml GARDASIL (lot number unspecified) intramuscularly. No adverse effect reported. It was unknown if the patient had sought medical attention. The outcome of the patient was unknown. Additional information is not expected.
COVID-19  Similar to symptoms of having hayfever. I thought I was having allergy problems. I had a low grade fever of 99.1 so we tested and it was positive immediately. They put me on Paxlovid since Tuesday pm and today I'm feeling better.
Experienced symptoms of syncope, dizziness, vision briefly went black, rapid heart rate, weakness
Fever 36 hours 102 Arm cellulitis Swelling armpit Viral symptoms
redness about 5"x5", mild swelling, with small 2mm bumps, screaming/crying for several minutes after vaccine, lungs clear, no difficulty breathing.  Redness and swelling went down within 20-30min after shot with ice pack - redness was <1" diameter and swelling was gone.
Pain and swelling L deltoid at site of injection  5.5 x 7.5 cm area.  Also fever that began 24hrs after injection of Td.
muscle cramping moved up from injection site in left arm through back of shoulder muscle then up left side of neck to ear, when reached neck- throat started to tighten, felt like cardboard in back of my throat,  VAccination nurses noticed I kept clearing my throat said it felt like cardboard in back of my throat.  They made me wait longer than the 30 min with them after I started coughing .  They offered benadryl. I agreed to use my epipen and call 911 if it got worse. I raced home to take more benedryl and took another 20mg of Prednisone as well as Flerxeril in case it was muscle spasm that caused throat to tighten.  Woken up at 6AM with terrible stomach cramps that had me in bathroom frequently with loose stool. Throat very tight, vocal cords strained, soreness moved to left armpit, very SOB upon exertion,  felt weak, tired, with really bad headache.  Reported to employeed health and PCP messaging site,  told to get 2 COVID tests which resulted negative.  Have had SOB upon exertion, chest tightness,  heart flutters, headache,  tight neck, and strained vocal cords, with really dry mouth, thick dry tongue, and unquenchable thirst. Symptoms finally feel almost gone today 9/29.
71 yo M admitted for sepsis from perforated gangrenous cholecystitis c/b E coli bacteremia, s/p lap chole 1/14 then found to have post-op collections now s/p drain placement of medial collection and aspiration of lateral collection.  CT evaluation for pulmonary emboli on 1/22/21  discovered, "Bilateral upper lobe segmental/subsegmental pulmonary emboli.  No evidence of pulmonary infarct or right heart strain."
Fever, chills, headache, body aches, and upset stomach. Took ibuprofen and the fever went down but the aches persisted
Woke up next morning at 7am with itching hands, slight swelling in lips and ears, nausea and diarrhea. Itching and swelling subsided with a dose of Loratadine. Nausea worsened that night and vomiting ensued with diarrhea worsening. At bedtime, itching returned, sleeplessness, vomiting and sweating profusely from the scalp and face, slight difficulty filling lungs with air. Another dose of Loratadine calmed symptoms. Wednesday (10th) through the next Thursday (18th ), nausea persisted, but eased with Benadryl and Emerton. Diarrhea persisted through Monday (15th). No fever, no soreness, no headache.
A 37-year-old female patient who was known to be pregnant at the time, had received a 0.5 mL intramuscular left deltoid injection of ADACEL (Lot# C2994BA) on 21 August 2008. The patient is a refugee and was receiving the ADACEL as mandatory vaccination. The patient had no past medical history; however, it was "unknown" what the patient's past obstetrical history involves. It was also "unknown" if the patient was taking any other medications at the time of the ADACEL vaccination. It was not reported whether the patient had completed any prenatal testing's at the time of this report. The date of the patient's last menstrual period was not reported, but her expected date of delivery was reported as 04 January 2009. Primary care physician and OBGYN physician contact information was reported as "unknown." The patient has not experienced any adverse events since receiving the ADACEL vaccination on 21 August 2008. Follow-up information was received from an health care professional on 13 November 2008. The patient arrived from a foreign country in February 2008. The date of the patient's last menstrual period was 01 April 2008 and, as previously reported, expected delivery date is 04 January 2009. The patient's past obstetric history included six previous pregnancies that resulted in six live births with no congenital anomalies. Concomitant medications included prenatal vitamins. An ultrasound performed on 04 September 2008 was normal. Current pregnancy history includes ongoing tobacco use (10 per day) and anemia. The patient had admitted to occasional alcohol use, but the reporter was uncertain if the patient meant before pregnancy or during pregnancy. It was indicated that the patient had not experienced any adverse events since receiving ADACEL however, clarification of onset date of anemia will be requested (on 29 September 2008, hemoglobin value was 10.0 and hematocrit was 29.0). Follow up information was received from an health care professional on 05 January 2009. The patient was diagnosed with anemia on 29 September 2008. The patient was treated with prenatal vitamins. The patient had a PPD test performed on 21 August 2008 (manufacturer, lot number, route and site was not provided). The result was negative. On 16 December 2008 the patient delivered vaginally without any pregnancy or labor and delivery complications. The patient had a baby boy at 37.2 weeks gestation. The baby was 5 lbs. 15 oz. with an APGAR score of 7 at one minute and 8 at five minutes. The patient did not have any congenital anomalies. Follow-up report received on 27 February 2009 from a physician. The patient's Hgb level was 12.2 on 15 December 2008 which was prior to delivery. Per the reporter, the patient recovered from the anemia; however a recovery date was not provided. The case was reviewed by the reporter and he had no additional information to add at this time. No further information is expected. Follow-up information received on 27 March 2009 from a physician. The reporter thought that the patient may have moved out of state. No additional information was available at the time of reporting. Documents held by sender: None.