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 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 12:29 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 1:16 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced 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). 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 62.78.  Concomitant products were not provided.  On 13-Feb-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 31-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  On 20-Mar-2021, Excursion time was 09 AM and 10 AM, temperature was 34, 37, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  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.
- Large swelling at injection site.  1-1/2 inches high, 4-5" long and wide within 12 hours -Swollen and black and blue eye lid that hung down over eye within 12 hours -Flushing and red patchiness on both arms and hands from shoulder through tip of fingers with 24 hour with above symptoms.  They put me on a steroid -Severe flushing on face and eye lids 2 days injection and continuing now into day three after injection along with high blood pressure up to 203/114
Large  raised red rash surrounding injection site - approximately 3?x4?. Itchy Lasted 3 days and faded
Several hours after the 4th shot, arm started hurting, turned black and blue, hot to the touch, rash, headache, nausea, aches and pains in all joints, felt sick and had  flu-like symptoms. The next day. arm still hurts, hives and itching. About a week later, still didn't feel well and went to ER and they said it would go away. The itching and swelling did but swelling in knees and arthritis is setting in with pain in arm joints. Went to MD and he prescribed pain killer and Feldene. X-rays from ER visits were sent to PCP for long-term pain treatment.
COVID 19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for 5 days at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: WELLBUTRIN. The following information was reported: COVID-19 (medically significant) with onset May2022, 9 days after the suspect product(s) administration, outcome "recovered" (May2022), described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset May2022, 9 days after the suspect product(s) administration, outcome "recovered" (May2022), described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Negative, notes: I began testing negative on the fourth day off Paxlovid treatment; (May2022) Positive; (May2022) Positive; (17May2022) Positive, notes: positive tests lasted 3 days. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Patient experienced a rebound of Covid-19 symptoms 5 days after completing a 5 day course of Paxlovid. patient began testing negative on the fourth day off Paxlovid treatment but then tested positive again 5 days after finishing Paxlovid. My rebound  symptoms and positive tests lasted 3 days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Patient stated that the morning after receiving the vaccine she woke up with hives covering her entire torso, buttock and legs. By mid-morning they had started to decrease and by afternoon the hives were basically resolved. She has stated she has never had this type of reaction to an influenza vaccine before and she did not use or take anything different that night other than receive the influenza vaccine.
One week following injection, 4 x 4 inch reddened rash  area noted at injection site. Area was slightly raised and mildly itchy. Lasted about two days.
Left deltoid area swollen, redenned, warm and tender ~ 2 1/2 circular area.  Patient complained of itching and pain to area.  Diagnosis with allergic reaction secondary to vaccines and cellulitis secondary to vaccines.  Immunizations given on 05/07/2003 reaction began 05/08/2003.  Came to MD office 05/09/2003 for visit with provider.
On the 4th day after vaccination I began having a pain in my left knee which lasted over a week. During that time I began having a hip joint pain, which lasted over 4 weeks.  few days after the knee pain I got a sharp pain in my left big toe for 24 hours, then a throbbing pain above my right ankle which lasted about a week.  After over 4 weeks all my pain was gone and no other issues continued.
Patient stated that her right arm at site of injection turned red, was warm to touch, and the area was itching and swollen.  Had put cold compresses on thea area, which helped aleviate the itching.
Headache, nausea, muscle/body aches, stomach pain , swelling/pain at site injection
No adverse event; Administered with expired monovalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired monovalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 005M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired monovalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with expired monovalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered with expired monovalent vaccine).    No concomitant medication reported.  Patient was inadvertently administered with the monovalent vaccine which was past beyond the manufacturer expiration date.   The vial size was 5.5 ml. The vial did not undergo any temperature excursions. The vial was removed from the freezer to the refrigerator on 02-Sep-2022.  No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-661787 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2022: Live follow-up received and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661787:Bivalent Dose Case
Started with the chicken pox 03/10/2005.  Step-brother just got over the chicken pox.
Red, sore, swollen, temperature of 100, don't feel sick just arm hurts.  Patient took Tylenol. Coordinator recommended applying a ice-pack, take Tylenol, no lifting per that arm, elevate arm at rest, phone MD if problems persist. Patient went to physician....antibiotics were ordered ...at this time everything resolved....
I had fatigue for 10 days plus. I started with pain in my upper right back about 2.5 weeks after the 2nd Pfizer injection.  Thinking it was a pulled muscle, I used heat, ice, took Ibuprofen, it has gotten worse each day. I noticed a scabbed over rash on the area and called my Dr. he never returned my call, so I called telehealth and sent a picture as the pain became tingling and moved up my neck and to the base of my head. He diagnosed it as Shingles. Today I have chills & a headache. After reading reports of some adverse reaction from the Covid -19 vaccine, I thought I should report this.
Sore throat and headache. Runny nose, sneezing and Productive cough next. And Had a fever once and 02 went down to 95 and then to 92 and then back up. I got Tylenol (took it around the clock - until the week after the hospital due to headaches); Vit D; and I took herbal teas Ginger/Turmeric and water. I had Telehealth visit the whole time. I went to ER when  02 went to 92 and I couldn't smell. I couldn't lay down - had to sit up due to not being able to breathe. I couldn't bend down without being out of bed. I still was short of breath  for about three weeks after.  Fatigue lasted that long, too. They gave me some  (Received Oxygen for breathing at ER). My sense of smell has now returned - not sure when. I'm back to going to gym now - I can walk around and not get out of breath.
tc from mom 3SEP92 to state pt was having tremors of the lt leg; advised to see MD which mom did; MD evaluated pt & stated that nerve may have been hit but that feels pt will fully recover; mom stated tremors had greatly dec by 8SEP92;
This spontaneous report was received from a nurse refers to an unspecified pediatric patient of an unknown age and gender. The patient's pertinent drug allergies, concurrent conditions, medical history and concomitant medications were not reported. On 06-DEC-2018, the nurse reported that an unspecified pediatric patient was administered a properly stored but expired VAQTA (strength, dose, route and indication were unknown) with a lot# N023953 and expiry date 05-NOV-2018(expired product administered) and no adverse effects reported (no adverse event). No additional information was provided.
?Covid arm? large red patchy round rash at site of injection that is warm to touch and itchy
Abdominal Pain, inflammation and burning.   Chest pain and carpal tunnel pain and arm pain
Extreme arm pain with pain radiating down arm and up in neck. Patient states cannot move arm due to pain. Patient putting ice on arm and taking Tylenol.
The Moderna vaccine was accidentally given to this 13 year old - rather than the Pfizer vaccine. Both the PCP and the mother have been notified of the error. At the time of this writing, the child has not suffered any adverse event pertaining to the vaccine error.
No adverse event; Nurse reports improperly stored PROQUAD was administered; This spontaneous report was received from a Licensed Vocational Nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 28-DEC-2022, the patient was vaccinated with improperly storaged measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), lot number W012730 with expiration date 16-OCT-2023 for prophylaxis (dose, route of administration and anatomical location were not reported); administered along with sterile diluent.     The temperature excursion was -14 degree Celsius up to -10 degree Celsius (-13.7 degree Celsius) for a timeframe of 5 hours and 15 minutes, without previous excursion. No adverse events reported.; Sender's Comments:  US-009507513-2301USA008920:
Blurry vision 45 min after the shot. Chills in the afternoon lasting about an hour. Fever in the afternoon lasting an hour. 4 days after the shot, sharp pain between my right groin & knee. Pain woke me up out of a dead sleep (blood clot??). Sharp pain came/went 3-4 times that day. Did not return the following day. Tingling & numbness in my right foot the day after the groin pain
Pain of right deltoid since injection, still ongoing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Oct2021 (Lot number: ff2590) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 28Oct2021, outcome "not recovered", described as "Pain of right deltoid since injection, still ongoing". The event "pain of right deltoid since injection, still ongoing" was evaluated at the emergency room visit. Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: It was reported that the patient did not administer other vaccine in four weeks, and no other mediation administered in two weeks. Patient never had Covid prior vaccination and not tested for Covid post vaccination. No known allergies were reported. The AE resulted in Emergency room/department or urgent care]]. Facility type vaccine was Pharmacy or Drug Store  No follow-up attempts are possible. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: Tested negative on day5; (May2022) Positive, notes: Tested positive without symptoms on day 10. Therapeutic measures were taken as a result of covid-19, drug ineffective. Treatment received start date 17May2022 and stop date 21May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness, itchiness, swelling at site of injection (4" diameter spot at injection site). Skin is warm to the touch - took BENADRYL tablets po - applied hydrocortisone cream to affected skin.
Cold feeling, extreme muscle pain, extreme joint pain, flu like sick feeling, extreme fatigue for 30 hours.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 09-DEC-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (dose was not reported) lot # J014812, expiration date 20-FEB-2015, subcutaneous. No adverse effect has been reported. Additional information has been requested.
first dose on the 21january2021 and the second dose on the 22april2021; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on the 21january2021 and the second dose on the 22april2021) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included LORAZEPAM, THIAMINE, VALPROATE SEMISODIUM (DIVALPROEX), HEPARIN and FOLIC ACID.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on the 21january2021 and the second dose on the 22april2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on the 21january2021 and the second dose on the 22april2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
FEVER; DIARRHEA; This spontaneous report received from a patient concerned a 27 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, and batch number: 1802072 expiry: 14-MAR-2021) dose was not reported, administered on 13-MAR-2021 for covid-19 virus prevention. No concomitant medications were reported. On MAR-2021, the subject experienced diarrhea. On 13-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and diarrhea. This report was non-serious.
1 .03:00 P.M received vax around 6 or 7 became tired  and slept for 14 hours 2.  went into town around 10.00 next day heart started pounding and was severely nauseous, , while driving became very distracted. pulled into parking lot still nauseous, 3. Called worker health  around 11:00 went To ER around noon, heart still beating rapidly , pulse was extremely high, was discharged around 3 , Later that evening heart began rapidly accelerating again, Pt began to walk and exercise to bring down his heart rate. His heart would accelerate and fall , then he passed back out again and slept through night.  4. next day went to open gate around10 a.m. noticed his hands were very white and heart had become rapid, he began to walk and decelerate his heart this did not help,  5. Went back to ER  and was discharged around 9 p.m. that night 6.  that night was awaken around 3 a.m. to rapid heart beat and heart rate.  this lasted 4.5 hours and then finally subsided
received a /2 to 1/3 of vaccine dose with no adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 76 years old male patient who received a 1/2 to 1/3 of vaccine dose with no adverse event while receiving vaccine influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 13-Oct-2022, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at a 1/2 to 1/3 of vaccine dose (0.7 ml) (lot UJ882AB, expiry date: 30-Jun-2023) via intramuscular route in the right deltoid for Immunization.  On 13-Oct-2022 the patient developed a non-serious received a 1/2 to 1/3 of vaccine dose with no adverse event (incorrect dose administered) (same day latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
he only got some pain on his arm where he got the injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old male patient received bnt162b2 (COMIRNATY), administered in arm, administration date 22May2021 (Lot number: EW0191) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "smoker" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 01May2021, when the patient was 56 years old, for Covid-19 Immunization, reaction(s): "he only got some pain on his arm where he got the injection", "it was a little red". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "he only got some pain on his arm where he got the injection". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that the patient did not experience fever after dose 2 vaccination and he was tested negative 3 times and again tested negative last week.  Follow-up attempts are completed. No further information is expected.
About 27 hours after my vaccine (at about 9 pm on 01/12) I began having 8-10/10 chest pain. Mostly burning sharp pain, but some restricting tight pain as well, radiating to my back mostly. It would be relieved for maybe 10 minutes at a time but then flare back up for about 5 hours. I went to the emergency room, where they did a cardiac work up including blood work and EKG, vitals and a chest X-ray, all which were unremarkable. At about 0200 am on 01/13, the pain subsided. Previous to the chest pain, during the morning and afternoon of 01/12, I had a low grade fever (99.9 F), an intense headache, and fatigue. 01/14/21 sore swollen lymph node under L arm.
Soreness at injection site starting a couple hours after the injection.  Soreness continued for a day and then gradually decreased.  Now (3 days after injection) it is sore when touched, but not painful otherwise.  After a day the soreness did not interfere with normal activity including splitting wood.  Other than that there were no noticeable side effects except that I might have been a little sleepier that than normal.  (Answer to question 20 should be "mostly".
Patient turned pale and fainted within a minute of vaccine administration, but regained consciousness within 10 seconds. Breathing was normal and patient was lucid after regaining consciousness. Paramedics were called and escorted patient to ambulance to be evaluated further.
the patient is clinically stable. She is afebrile with stable vital signs. She endorses intermittent generalized abdominal pain, generalized weakness, fatigue.  She denies fever/chills, chest pain, shortness of breath