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 60-year-old female 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 12:01 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-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 60.94.  Concomitant products were not provided.  On 20-Mar-2021, excursion time was 9 AM, temperature was 34, total doses given for the day was 184 and on same day, excursion time was 10 AM, temperature was 37. 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.   This case was linked to MOD-2022-566976 (Patient Link).
The pt experienced rash and a few hives across chest approximately 30 minutes after receiving the Hepatitis A vaccine.
HARD TO BREATH, FOREHEAD AND EARS WERE ON FIRE, HEART WAS POUNDING.
Pt got the flu shot on 9/6/18 around 10 am and started to have symptoms including hoarse throat, body aches, red face, bloodshot eyes, headaches and swollen neck. He also reported not being able to sleep that night. He took 1 cyclobenzaprine 10 mg tablet for muscle pain. The symptoms resolved on 9/7/18 around midafternoon. He reports feeling a lot better since then. Pt reported 9/8/18.
Shingrix was given on 5/20/20 in (L) left Deltoid IM. on 5/21/20 patient called and told RN she has a red circle on the arm, its hot to the touch and big, patient states "her stomach is also feels sick with some cramping pains". On 5/22/20 patient talked with RN again the area is larger in size measure 4 x 4" still red and Hot the touch. Ice & Hot pack were applied
Vaccine administered at 9AM, about 9:15AM patient C/O felling light headed, bp 110/70 - no other Sx, then over next 15-20 min., became nauseous and vomited x3. No rash, without swelling, positive soreness at injection site - without visible redness, swelling. BP/pulse remained stable, dizziness and nausea subsided after 3 hrs. but she has headache. Temp - 99.0.
On June 21st, currently ongoing. There has been no diagnosis or treatment. It started with sharp abdominal pains and swelling. It has since expanded to abdominal, back, shoulder pain. The abdominal swelling has not went away.
Serious burning lung pain. Lasting about 12 hours. Feeling like ribs are broken.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age with not pertinent medical history, allergies or drug reactions. On September 2013, the patient was vaccinated with PNEUMOVAX23 (lot # J007059; expiration date, 31-JUL-2013) 0.5 ml, intramuscular, applied in her left deltoid. There were not concomitant medications by the time of the report. On September 2013, the patient experienced a fever with redness and swelling at the administration site within 24 to 72 hours of administration. Treatment recommended over the phone was ice and TYLENOL. Diagnostic studies were not performed. The outcome of the events was reported as recovered. The relatedness between the events and PNEUMOVAX23 was not reported. A lot check was requested by medical assistant. Additional information has been requested.
LEG SORENESS COULD BE DUE TO EXERCISING; MUSCLE SORENESS COULD BE DUE TO EXERCISING; This spontaneous report received from a consumer concerned a female of unspecified age. 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: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 03:00:00 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced leg soreness could be due to exercising, and muscle soreness could be due to exercising. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle soreness could be due to exercising and leg soreness could be due to exercising was not reported. This report was non-serious.
no adverse effect; inadvertently administered an expired dose of VAQTA; This spontaneous report as received from a medical assistant regarding to a patient of unknown age and gender.    There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.      On 17-APR-2019, the patient was inadvertently administered an expired dose of hepatitis a vaccine, inactivated (VAQTA)  25/0.5 (lot # R009952, expiry date: 17-MAR-2019) intramuscularly for prophylaxis.       No temperature excursion. No adverse effects were reported.
1/2 hr after injection, rash to chest and arms. 6-8 hrs after injection nausea and vomiting. 1-2 days after injection, mild diarrhea and blood in stool.
Red blotches all around injection site. Painful at injection site- 9/10. Chills, muscle pain - 7/10, restlessness, unable to sleep. No fever.
Pt called 9/20 & reported painful/itching at injection site. Was told to take BENADRYL by RPh on duty. Called back 9-21-11 & was asked to return to pharm. Site observed & pt referred to MD. MD treating patient for cellulitis.
My arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PAIN IN EXTREMITY (My arm sore). At the time of the report, PAIN IN EXTREMITY (My arm sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Child could not stand up or walk. We are on day 5 and she still cannot bear any weight or walk on right leg, the leg the vaccine was administered in!!!
Following administration of vaccine, recipient felt soreness and a knot at the site.  On Wednesday (10/14/2009), recipient noticed a scab approximately 7-8 mm in diameter with redness at the periphery of the scab.  Recipient continues to feel soreness at the date of this report.
Rash at site of Varicella vaccine in Left upper arm, then few days later, at injection site in right upper arm. Consistent with varicella.
Vaccine administered at patient's home 1/1/07 in evening. On 1/3/07 mom noticed Right upper arm redness, warmth, then 1/4/07 worse with nausea, low grade fever, rash
Accidental administration of second dose of Pfizer-BioNTech COVID-19 2023-2024 formulation. Child was previously vaccinated with this product on 10/15/2023.
FRIDAY NIGHT PAIN. SATURDAY BRIGHT RED/PAIN AT INJECTION SITE ABOUT THE SIZE OF A BASEBALL. SUNDAY STILL EXPERIENCING REDNESS AS WELL AS NAUSEA MOST THE DAY. MONDAY REDNESS FROM THE SHOULDER TO THE ELBOW. TUESDAY MORNING BLACK/BLUE ON ARM WITH REDNESS MOVING TO CHEST.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were  not reported. On 12-APR-2016, the patient was vaccinated with improperly stored VAQTA 250U/0.5 ml, lot # L004743 with expiration date: 01-JUN-2017, via intramuscular route (dose not reported).  Administered dose of VAQTA underwent temperature excursion at 31.1 Fahrenheit degrees, for 82 hours. There was no previous temperature excursion. There was no adverse effect reported. This is one of the several reports from the same source. Additional information has been requested.
RPh noticed tense muscle when injection was given. About 3 minutes after shot patient asked if muscle was supposed to be throbbing - he said it was in different area from injection. RPh told patient that it might be nervous muscle spasm and to wait a little longer til it passed. It passed.
Spoke with the grandmother this morning the incident yesterday regarding the peds pfizer booster 5-11 yrs was not diluted and the signs and symptoms the family should watch out for grandmother said she did not notice any changes. He is fine he went to school and as his usual self no complaints. I explain I will check back tomorrow and Saturday for any changes.
Intense nausea, vomiting, weakness/fatigue, for over 3 days (minor headache, low grade fever, some chills, some sweats).  Stayed in bed for 3 days, unable to eat or drink due to extreme nausea, unable to hold food, vomiting.  Called my primary doctor who prescribed me anti-nausea/vomiting drug.  Had my monovalent mRNA COVID-19 Pfizer vaccine last year fine, but the Bivalent booster side effects were intense.  I have never felt so sick.  This is day 4 as I'm typing this, slightly feeling better, but weak and shaky inside, queasy feeling.
Information has been received from a Registered Pharmacist (R.Ph) concerning a 66 year old female patient who used KENALOG about 1 to 2 weeks for skin condition and no known drug allergies/drug reactions who on 04-MAY-2009 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # 664092/0198Y) subcutaneously. It was reported that on 05-MAY-2009 the patient experienced redness, tenderness, swelling and itching at the site of injection. The area was about 2 inches by 2 inches. The patient sought medical attention via telephone. It was reported that the patient was taking diphenhydramine. There were no laboratory diagnostic tests performed. On 06-MAY-2009, the patient reported to the pharmacist that the area was no longer swollen but was still red and increased in size. It was reported that the patient was recovering at the time of the report. Additional information has been requested.
The day after the shot (4/28) felt extremely tired & weak.  Heel of rt. hand very sore to touch, swelled & hard to  bend hand at wrist.  Also rt. arm triceps area swelled.  Both  areas sore and ached.  Went back to bed after breakfast for 1.5 hours.  Low back became sore and ached.  After 9:30pm started to feel somewhat better, but hand and arm no better and somewhat more swelled. 4/29 - Heel of rt. hand more swollen, Hand & arm still aching.  4:00pm started to feel considerably better.  6:00pm swelling in hand & arm starting to subside.  4/30 - felt good all day, but heel of rt. hand still sore. 5/1- feeling good, soreness in rt. hand 95% better.
I had a very active day Friday 10/23 after receiving the shot and didn?t feel any adverse effects. By the night time my right arm began to become very achy. I later woke up in the middle of the night with much deeper arm pain. By morning I could no longer lift my arm or use my arm/hand. This continued until I woke up on Monday morning 10/26. The entire weekend I had to hold my arm against my body while walk or moving in order to stay comfortable and the pain was so intense and deep that I got very little sleep. By Monday 10/26 I was able to move and lift my arm again and the pain gradually subsided. I get a flu shot every winter and I?ve experienced arm muscle pain following the shot each time but nothing like this has ever happened to me. I was completely incapable of moving my entire arm for 2 1/2 days.
First dose: blood pressure rose within 30 minutes, light headed for 5 minutes; First dose: blood pressure rose within 30 minutes, light headed for 5 minutes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NASONEX. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 01Apr2021, outcome "unknown", DIZZINESS (non-serious) with onset 01Apr2021, outcome "recovered" (01Apr2021) and all described as "First dose: blood pressure rose within 30 minutes, lightheaded for 5 minutes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood pressure increased, dizziness. Additional information: Facility type vaccine was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received OTC Nasonex medications within 2 weeks of vaccination. After First dose blood pressure rose within 30 minutes and lightheaded for 5 minutes. The patient dont have a history of high blood pressure, it's always been in the normal/excellent range. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt vac.W/DTP/OPV plaintiff alleged that as a result of immunization on 14MAY84, 29JAN86 & 28APR87 child experienced a grand mal seizure within hrs of first vaccination, & permanent brain damage.
Initial unsolicited report received from a nurse on 9 December 2015. This case involves a 28-year-old male patient who was vaccinated with a first dose of MENACTRA (manufacturer: Sanofi Pasteur, batch number: LU5180AA, expiration date, dose were not reported) intramuscularly in right deltoid on 20 November 2015, a first dose of yellow fever vaccine (Manufacturer: Sanofi Pasteur, batch number: UI095AA, expiration date, dose were not reported) subcutaneously in left forearm on 4 December 2015 and a first dose of TDAP (manufacturer: Sanofi Pasteur, batch number: U5263AA, expiration date, dose were not reported) intramuscularly in left deltoid on 20 November 2015. The patient also received a first dose of PREVNAR 13 (manufacturer: Wyeth, batch number: L60103, expiration date: December 2016, dose were not reported) intramuscularly in right deltoid on 7 December 2015 at 08:00 hours. The patient did not have pre-existing physician diagnosed allergies, birth defects, medical conditions. There was no illness at time of vaccination. Concomitant medication was not reported. On 8 December 2015 at 16:00 hours, 18 days following the vaccination, the patient developed 2.5 x 2.5 cm erythema in the right arm, it was warm and tender to touch and pain "2/10" with which had elevated right arm up. No laboratory investigation performed. The body temperature was 97 (unit not provided). Corrective treatment was not reported. On an unspecified date, the patient recovered from the events. Follow-up information received from a nurse on 05 January 2016. The patient's illness at the time of vaccination and other medications were reported as none. The patient did not require any treatment. On 14 December 2015, the patient was recovered from all the events. List of documents held by sender: none.
Rash developed arms and fingers accompanied by pruritus 2-3 days after vaccination.
Pt was seated to receive a vaccine.  She received the injection from who is working the event and did attend orientation on how to prep and administer the vaccine. Pt sts as soon as she was given the injection, she felt a very mild "sensation" in from her R hand to her R cheek and ear. She sts is just "so mild" she thought she might have been imagining it at first but it is now getting worse. She reports it feels like a mild sensation. She passed her 15 minute time wait as precaution for allergic reactions and went to the restroom. At 19 minutes after her dose was given, she reported it to the adverse reaction/signs and symptoms team. Pt sts it is slightly worse when she moves her arm but is still "quite mild". Vitals are stable and PMS is intact X4. Pt is given VAERS info and notified that event would be reported by medical staff on site. Pt sts she will follow up with her PCP.  Vitals during assessment are BP 125/81, HR 76, Sats 98%, RR 14
This case was reported by a pharmacist via call center representative and described the occurrence of blackout in a 66-year-old female patient who received SHINGRIX (batch number KR7G2, expiry date 2nd June 2021) for prophylaxis. On 1st May 2019, the patient received the 1st dose of SHINGRIX. On 2nd May 2019, 1 days after receiving SHINGRIX the patient experienced blackout (serious criteria GSK medically significant) and low blood pressure. On an unknown date, the outcome of the blackout and low blood pressure were unknown. It was unknown if the reporter considered the blackout and low blood pressure to be related to SHINGRIX. Additional information was reported as follows: The patient was blacked out while driving and totaled her car. The patient's physician told her that, the SHINGRIX could have lowered her blood pressure enough to cause her to pass out. At the time of reporting, the patient was facing a DMV charge.
1wk p/vax hosp w/pneumonia flu & asthma; fever 103 prior to adm; no fever for the 3 or 4 days p/vax;
reported a quadracel administration to a patient under 4 years of age, instead of the intended pentacel with no reported adverse event; quadracel administration to a patient under 4 years of age with no reported adverse event; Initial information received on 18-Aug-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 2 months old male patient and reporter stated that a DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] administration to a patient under 4 years of age, instead of the intended DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)]  with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination  On 17-Aug-2022 the patient developed a non-serious event of reported a quadracel (dose: 0.5ml, route: intramuscular, formulation, strength, batch and expiry date was unknown) administration to a patient under 4 years of age, instead of the intended pentacel with no reported adverse event (wrong product administered, product administered to patient of inappropriate age)(Latency: same day) for Immunization.   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.
Severe swelling of the tongue started after midnight 4/22/2021. Was seen in the emergency room at 4am and given Benadryl, Dexamethasone, and Pepcid.
Beginning following day after vaccination, pain, erythema, edema, itching, stinging of left upper arm. Also reports exacerbation of previous skin rash & HSV 2 outbreak; today has dry, patchy area on U.A. (3cm x 1.5 cm); no swelling, no erythema; treatment - Aloe vera at HS, "soothing".
no adverse event; Someone was supposed to get Moderna Bivalent & received the Moderna Monovalent instead; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Someone was supposed to get Moderna Bivalent & received the Moderna Monovalent instead) and NO ADVERSE EVENT (no adverse event) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 063B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Someone was supposed to get Moderna Bivalent & received the Moderna Monovalent instead). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Someone was supposed to get Moderna Bivalent & received the Moderna Monovalent instead) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Someone was supposed to get Moderna Bivalent &amp; received the Moderna Monovalent instead).    No relevant concomitant medications were reported.  No treatment information was provided.
I received the booster shot and began having SOB, extreme fatigue and dizziness.  I also had tremors and night sweats.  All symptoms lasting over 30 days but having decrease in symptoms as days go on.  Currently still having fatigue and some tremors as heart rate increases.