chrisvoncsefalvay/vaers-outcomes huggingface dataset:
accidentally given daptacel on 07Mar2023 that expired on 01Mar2023 with no reported adverse event; Initial information received on 08-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old male patient who accidentally received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] on 07-Mar-2023 that expired on 01-Mar-2023 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) for Prophylactic vaccination; and HIB vaccine CONJ (TET TOX) (ACTHIB) for Prophylactic vaccination.  On 07-Mar-2023, the patient accidently received a 0.5 mL dose of expired suspect diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection, (strength - standard, frequency - once (1x), lot - C5829AA and expiry date - 01-Mar-2023) via intramuscular route in the right thigh for immunization with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
swollen & painful lymph nodes in arm pit on side of injection petechial rash on abdomen, pelvis & inner thighs headache
After my vitiligo being stable for 25 years I began to rapidly depigment after contracting COVID in January. I had an annual physical after my COVID vaccine and all hormones levels etc. were consistent with previous visits.  Once I caught COVID I believe my autoimmune condition was aggravated by the presence of the vaccine AND the naturally occurring COVID virus.  I am losing large ares of pigment very rapidly.
This is a spontaneous report from a Pfizer sponsored program from a contactable consumer who reported about herself. A 71 year old female patient received PREVNAR 13 on an unspecified date, at single dose, for immunization.  Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced pneumonia. Clinical  outcome was unknown at time of this report. The information on the lot number has been requested.
1625: Received vaccine.  1626: Pt slumped over in chair and was laid down by myself left lateral.  Pt denies loss on consciousness.  Moved pt to back area for observation with EMT.   1628: Pt states that she felt lightheaded and nervous but is breathing unlabored without distress. Pt denied previous reaction to the first dose when he received it in the car. Pt's dad stated that she has no prior medical hx. Pt initial  VS: BP 108/64, HR 84, SpO2  99%, RR 14.  Pt repeat VS was 80/46 pt stated that she was feeling light headed again and that she had some chest tightness. Pt appeared anxious.  SpO2 98% HR 64. Pt stated that she was feeling the same way as before she got dizzy the 1st time.  Pt was laid on the floor and pt stated that she felt better. pt repeat BP 98/58, HR 78, and SpO2 was still 99%. Pt laid on the floor for approximately 5 minutes and given water and snack. Pt sat up slowly and stated that her chest felt better and ate snack.  Pt was kept for approximately 10 more minutes under monitoring. Pt in total was monitored for 34 minutes. Pt was released with father. pt stated that she felt like she was back to normal again. Pt last set of vitals were: BP 116/58 HR 78 SpO2 99. Pt was released to her father.
Cellulitis - Rx Duricel 250 mg bid 5 days.
PATIENT GOT DIZZY 5 MINUTES AFTER VACCINATION. RN THEN TOOK BLOOD PRESSURE AND HEART RATE. PATIENTS BLOOD PRESSURE WAS 150/90 AND HEART RATE WAS 115 AND UP TO 150. AMBULANCE WAS CALLED AND BLOOD PRESSURE WAS ALSO AGAIN 150/90 AND HEART RATE WAS AROUND STILL AROUND 115 AND UP TO 150. AMBULANCE WAS CALLED AROUND 10:43 AM AND THEY ARRIVED 5 MINUTES AFTER BEING CALLED., PATIENT WAS BROUGHT TO THE EMERGENCY DEPARTMENT BY AMBULANCE.
15 cm area of erythema surrounding injection site. 3 (0.5cm) blisters and 1 (2 cm) fluid filled blister at injection site
Initial mildly sore arm.  Two days later; pain in upper left chest similar to broken  rib or damaged muscles activated by motion: breathing, coughing, etc. A week later pain is less and clearly lessening.
Patient presented with large (4 inch?) red area which was located about 3-4 inches from where the injection was given.  Reports no pain or discomfort.  Area is not warm to the touch.   Had spread some since initial presentation.  Due to location unsure if due to vaccine or not.
RECEIVED LESS THAN 0.5ML OF VACCINE AS A BOOSTER DOSE (0.3ML); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 64-year-old male, with unspecified ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 1 in total, administered (dose number in series was 1) for prophylactic vaccination. It was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 11-APR-2022), 0.3 ml, 1 in total, administered (dose number in series was 2) to left arm on 01-DEC-2021 for prophylactic vaccination which was an off label use as patient received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose) (dose number in series 2). No concomitant medications were reported. As per the report, the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of vaccine as a booster dose (0.3ml) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210684, 20211209976, 20211210197, 20211210409, 20211210067, 20211210160, 20211210058, 20211209843, 20211210549, 20211209775, 20211210159, 20211210610, 20211210555, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211212088, 20211212082, 20211210824, 20211210588, 20211210670, 20211209551, 20211209679, 20211209740, 20211209798, 20211209874, 20211209884, 20211209706, 20211209843, 20211209921, 20211210019, 20211210350, 20211210106, 20211210107, 20211210112, 20211210141, 20211210143, 20211210165, 20211210180, 20211210334, 20211210385, 20211210590, 20211210662, 20211210733 and 20211209874.
9 year old boy received flu shot with 1" needle vs 5/8" needle.  Nurse who administered stated she did not go all the way in.  Site of injection bled quite a bit and mom stated within an hour of leaving here, he was complaining of substantial arm pain that lingered up into the neck and jawline.  His arm was bruising immediately and stated the bruise was the size of a dime.   I followed up the next day, and she stated minimal improvement with pain and bruise had worsened.  I followed up Monday (4 days after injection) and she stated bruise looked like it was improving but child had pain through the weekend (in his arm, neck and chin).  Mom stated she was going to call his primary doctor and potentially have him evaluated.
Pt stated that 4 days, post vax, he had swelling of extremities. Pt was not seen by health care professional nor was he treated for these symptoms.
Patient:   9/22/21- First dose of Pfizer vaccine administered 0.3 ml 5/17/22- 2nd dose Pfizer vaccine administered 0.3 ml 6/11/22- 3rd dose of Pfizer vaccine administered 0.3 ml  Spoke with patient on 6/21/22 upon discovery of 3rd dose. .  She reports  that  due to the long interval of time that passed since her first vaccine on 9/22/21, she was under the assumption that she needed to restart her vaccine series therefore she filled out a first dose consent at her 5/17/22 appointment, and a second dose consent at her 6/11/22 appointment.  Patient was made aware that she did not need to receive the 3rd dose and that the 9/22/21 and 5/17/22 completed her initial vaccine series. Director of Community Health Services notified of incident.
Treatment of COVID-19/Tested positive; Treatment of COVID-19/Tested positive; Moderna Dose Number: 1/Pfizer / BioNTech Dose Number: 2 & 3.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 2, single (Batch/Lot number: unknown), in left leg and on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Mar2021, outcome "unknown", described as "Moderna Dose Number: 1/Pfizer / BioNTech Dose Number: 2 & 3."; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19/Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment was Paxlovid for 5 days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax 16JUN98 & approx 6hr later 16JUN98 pt devel hives & throat constriction;pt was taken to ER;17JUN98 pt went back to work, but became tired & went home early;T104 18JUN98;pt kidneys reportedly were not functioning properly;
Fever with Tmax 102.4 and severe chills for approximately 36 hours after receiving the shot, mild response to Tylenol and Advil
Patient was given the vaccination as a result of an automated scrub process to identify necessary immunizations. After comparing results of a manual scrub process of required immunizations the issue was identified.  The patient did not display any symptoms or adverse reactions to the immunization.
left thumb pain, soreness; Left thumb warm; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ewo162) via an unspecified route of administration on an unknown date in Apr2021 at 04:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amlodipine besilate (AMLODIPINE BESYLATE), multi vitamin (MANUFACTURE UNKNOWN) and benazepril hydrochloride (Benazepril) from an unknown date for unknown indication and unknown if ongoing. The patient previously had no known allergy. On an unknown date in 2021, the patient experienced left thumb pain, soreness and warm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left thumb pain, soreness and warm was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
RECEIVED 11 YO SHOTS DURING SCHOOL CLINIC ON 5-12-14. STARTED HAVING RED WARM SPOTS AT THE SITES ON BOTH ARMS IN THE EVENING ON 5-13-14. ON 5-14-14 EVEN MORE SWOLLEN, RED, HOT, SORE AND ITCHY.  SEEN AT MD OFFICE ON 5-14-14 6:20AM. DR RECOMMENDED IBUPROFEN, ZYRTEC AND BENADRYL ALLERGY. DR DOCUMENTED "UNLIKELY CELLULITIS, MORE LIKELY LOCAL REACTION, BENADRYL AND WATCH CLOSELY-IF FEVER, VOMITING, RASH, RAPIDLY SWELLING, ANY PUS AT SITE OF SHOTS ETC CALL IMMEDIATELY OR GO TO HOSP, WILL REPORT RXN TO VAERS".
Tuesday: swelling, pain -- > became hard and tight; Wednesday (next day): tenderness spread down arm; resolved on its own.
Patient had 15cm x 15cm area of erythema and warmth.  Patient complained of itching and discomfort at site of injection.  Reported to office 48 hours after vaccine.
pt recv vax NOV95 & devel paresthesia;pt described a gen soreness of the skin which became sensitive p/any type of prolonged sitting;skin felt raw;B12 was in the low range of nl;
Reported 08/02/2023, red, mildly itchy, patches appearing 72 hours post varicella vaccination.  Continued to have itchiness with some red patches observed over her body.
Administration error - 2 month vaccines given at 1 month of age - child doing well, 0 concerns *No adverse reaction* Medical Assistant administered vaccines too early to a child. Dr. spoke with family hours after administration, patents told him child was fussy, no fever, eating well, no concerns.
Patient received the Covid-19 vaccine. She reports symptoms of feeling dizzy upon standing up to leave {Immediate reaction less than 1 hour}. I have observed Patient was able to walk to observation area where her VS were taken Treatment/intervention VS were as follows: 1825 - 145/46 HR 56 100% on RA - water and crackers given 1830 128/42 HR 54 100% on RA stated that she was feeling better 1836 - 141/46 HR 57 100% on RA Continued to drink water, eat some crackers, and was conversing, smiling, and laughing  1840- 144/70 HR 55 99% on RA. BP back to baseline normal. Patient stood up was steady, states feeling better.  Escorted to car doing well.
Patient left vaccination  center after receiving vaccine at 1:15 pm proceeded home arriving  around 2:00 p.m.  Blinding headache had settled in prior to arriving home and grew progressively worse. Headache is still extreme.
1st dose given 2/10/2021; 2nd dose given 3/3/2021; 3rd dose given 11/9/2021. All Moderna.
Racing of the heart, light headedness, shortness of breath, fatigue. Low grade fever for a couple of days. Numbness and tingling in the arms and legs(worse at night).
Needle popped out and vaccine landed in her hand; Not sure if received full dose; A spontaneous report was received from a (Consumer) concerning a 45 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced needle popped out and vaccine landed in her hand and not sure she received full dose.    The patient's medical history included unspecified surgery. Concomitant product use included duloxetine hydrochloride, zolpidem tartrate, and ketorolac tromethamine.    On an unknown date, the patient received their first of two planned doses of mRNA-1273. On 18 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (lot #not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 18 Feb 2021, during administration of injection, the needle popped out and vaccine landed on the patient's hand. The nurse put the needle back on and administered the remaining dose. The patient was not sure if full dose was received.  Action taken with mRNA-1273 in response to the events was not applicable as the patient received both doses.   The events were resolved on 18 Feb 2021.; Reporter's Comments: This report refers to a case of vaccine underdose and syringe connection issue for mRNA-1273 (lot #not provided) with no associated AEs.
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 POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 3:25 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (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 21.51.  Concomitant products were not provided.  On 28-Apr-2021, Excursion time was 09 AM, temperature was 33, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 28-Apr-2021. 4 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  On 28-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 40, 12 AM: 41, 1PM: 41, 2 PM: 39, 3 PM: 41 and 4 PM: 40.  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 Fisher brand 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 spontaneous report was received from a Licensed Practical Nurse referring to a pediatric patient of unknown age and gender and reporting as pediatric. Patient's pertinent medical history, drug, allergies and concomitant therapies were not reported. On 05-MAY-2015, the patient was vaccinated with the first dose of VAQTA (lot number and expiration date were not reported) intramuscularly. Later, the patient was administered with a second dose of VAQTA (lot number and expiration date were not reported) also intramuscularly. It was reported that the patient received two doses without six months between dose. No adverse effects were reported. Additional information has been requested.
At 6 pm I started having some goosebumps, at 9:00pm I felt cold, I was shaking a lot. At 3am the shaking started again.  At 7:00am I had  headache, pain on my eyes and a lot of body pain. Felt so tired and painful
A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events body aches, fever and conscious but very weak.  The patient's medical history was not provided. No Concomitant medications were reported.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection  On 31 Dec 2020, the patient experienced body aches, fever and conscious but very weak. No treatment information was reported.  The Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events, body aches, fever and conscious but very weak was not reported.; Reporter's Comments: This case concerns a male of unknown age who experienced NS events of unexpected asthenia and expected pyrexia, myalgia.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on 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.
8-13-08 still hot feeling well, pain tenderness all over. Fever 100-101 x 5 d nausea, dizzy, H/A, skin hurts, sharp shooting pain throughout body, felt like body bruised. Urgent care 8/20 diagnosed viral infection; Treatment Prednisone 20mg 1d x 5d. Doctor thought symptoms not related to vaccines. 8-21-08 continues to be weak, tired, unable to do daily activities.
Developed diarrhea several times after taking the first dose of ORAL Typhoid. No fever. No vomiting.
Approximately six hours post vax, the pt had 15 - 20 small purpuric lesions on both lower legs. No other symptoms.
PT PRESENTED TO PHARMACY ON WED 10/12/16 WITH A RED RASH ON HER ARM FOLLOWING VACCINATION.
inadvertently administered an expired pentacel with no reported adverse event; Initial information received on 12-Sep-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1 years old female patient who was inadvertently administered an expired pentacel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Sep-2023, the patient received suspect diphtheria/tetanus/5 hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection expiry date: 09-Sep-2023 via unknown route in unknown administration site for prophylactic vaccination (strength, dose, batch number: unknown), inadvertently administered an expired pentacel with no reported adverse event (expired product administered) (latency same day). Information on the batch number was requested  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered  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 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.
Wife described a putrid metallic odor coming from my body and had an allergic reaction after kissing me. She experienced numbness and tingling on her face and lips as well as hives on her face and neck that was treated with Benadryl.  These symptoms went away after a few hours but she was unable to come in close proximity to me until the next day.  Also experienced, soreness around injection site, body aches, fatigue, flushing of face, headache, light headedness.  All of these symptoms subsided  within approximately 36 hrs. after time of vaccination with plenty of rest.