chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 3:40 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 3:46 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 44.40 for batch number 014M20A and 44.47 for batch number 019B21A.  No concomitant medications were reported.  Batch number 014M20A administered on 27-Feb-2021 had  temperature 33 at 09:00 AM, 35 at 11.00 AM, 12.00 PM, 01.00 PM and 02.00 PM. . This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  Batch number 019B21A administered on 27-Mar-2021 had  temperature 35 at 09:00 AM and 10.00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported
Patient received her first dose of the Pfizer vaccine lot number EW0178 at about 304. Approximately 5 minutes after receiving the vaccine she reported having "chest pain". She stated she had a history of angina in the past over the last two months. Since being diagnosed with COVID. Lung sounds are clear. No stridor indicated. No s/s of allergic reaction or anaphylaxis.    VS Stable BP=  128/71 Pulse= 84 O2+ 98% Resp 16   Pain varies from 4-6 "sharp pain in the middle of her chest."    EMS called.    Repeat vital signs remain stable    1530 BP= 114/80 HR= 89 O2= 99% Resp= 20   Medics arrived at 1535 and took over care. EKG acquired.     Follow up VS BP=122/67 P=84 O2=98% Resp= 22   Patient transported to the ER
Patient woke up Saturday, 6 Feb, with multiple small raised welts on left shoulder around injection site.  Site was itchy.  Over the course of the day, site enlarged slightly with a little warmth, but nontender.  That day, took a dose of Benadryl and applied topical Hydrocortisone.  On Sunday, 7 Feb, area began to improve and applied more Hydrocortisone and took additional Benadryl .  Pt stopped her Allegra these 2 days as she was not sure if could take all meds together.  On Monday, 8 Feb, patient walked into our Allergy/Immunizations clinic (protocol for anyone who receives an injection and has concerns about a reaction) at our facility and I examined the area with very faint residual erythema, but nonpalpable and nontender.  No further itching by Sunday night.
Patient tolerated vaccine well and waited in the room for a phlebotomist to draw blood.  As soon as the phlebotomist drew his blood, pt. started retching with very minimal vomitus.  No facial swelling or hives noted.    Not tachypneic, SPo2 97% RA.  Pulse 77, Temp 98.6 Oral,   Lungs clear.  Patient stated he had felt hot and then nauseated.  Patient reports he had not eaten that day.  MD felt he had a vasovagal episode brought on by not eating.    Vitals retaken at 3:40 pm and all were WNL.  Left office at 1548 in NAD.
After receiving flu shot on 1/26/2015, patient experienced nausea, tingling, vertigo and weakness. She began feeling itchy. She went to the emergency room. She received prednisone and famotidine. She began taking BENADRYL.
Suspected vaccination failure; Shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed shingles after having gotten vaccinated with Shingrix. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.    The reporter did not agree to follow up with GlaxoSmithKline. This case is one of 3 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR233842:Same reporter US-GLAXOSMITHKLINE-US2021AMR233832:Same reporter
Information was received on 29-JUN-2017 from a registered nurse regarding multiple unspecified patients. Medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates from 27-MAY-2017 to 01JUN-2017 the patients were administered improperly stored doses of GARDASIL 9 (lot # M036059, expiration date 03-JUN-2020) dose not provided); M-M-R II (lot # M007279, expiration date 09-FEB-2018 and M032487, expiration date 05-JUL-2018) dose not provided); PEDVAXHIB (lot # M034188, expiration date 20-MAY-2019 and N000235, expiration 26-OCT-2019) (dose not provided); and ROTATEQ (lot # M040268, expiration date 14-MAY-2018) (dose not provided). Temperature: 47 degrees Fahrenheit to 77 degrees Fahrenheit Timeframe: 48 hours Previous temp excursion: No Was call because of a data logger: No. No adverse effects were reported. The outcome of the event was not reported and the causality. No further information was provided. Additional information has been requested.
Who: See above What: EMS called and patient transported to ED Where: vaccine site When: See above: Why: Anaphylaxis to first dose of Moderna. After vaccination pt presented with coughing, redness of the face and arms, and stated that it felt like her neck was swelling.  She explained it as "it feels like someone has their hand on my neck and choking me."  Pt has hx of anaphylaxis and has an Epi pen.  HR was 120, RR 30, BP 170/90.  Pts condition was getting worse so she was administered an adult epi pen.  HR increased but after 5 min pt was coughing less and face became less red.  She also said she felt better.  Vitals were reassessed and pt handoff was given to
Vaccine administered to a 12-year-old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 12-year-old patient) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 12-year-old patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 12-year-old patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Patient aged almost 13 years
pt was terrified of getting shot, after shot was crying , i asked if okay she said yes, we put her in a room to keep an eye on her, she eventually passed out, then seemed out of, we wre told she was on axiety meds, ambulance came, said she had low blood sugar and took her
Patient reported a large circle around the injection site of redness and a lot of swelling. She said it started the evening of 2/16 but got worse on 2/17 so she saw her private physician. Per patient physician thought it was just a local reaction but wanted to have the Health Department evaluate. Patient reported she iced the site yesterday and it has improved. I evaluated the site and noted a faint red circular area around the injection site approximately 10 cm then a smaller darker red area in the center slightly raised (probably the injection site)approximately 1cm.
Pt recvd Engerix-B on 1MAY90, 30MAY90, & 30OCT90 subsequently was found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
left leg went completely went numb and disappeared and felt as if it was not there; sank down to the ground and was on floor; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (left leg went completely went numb and disappeared and felt as if it was not there) and FALL (sank down to the ground and was on floor) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, LEVOTHYROXINE SODIUM (SYNTHROID), TOPIRAMATE and AMLODIPINE for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced HYPOAESTHESIA (left leg went completely went numb and disappeared and felt as if it was not there) and FALL (sank down to the ground and was on floor). At the time of the report, HYPOAESTHESIA (left leg went completely went numb and disappeared and felt as if it was not there) and FALL (sank down to the ground and was on floor) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was received for events.
RASH OVER ENTIRE BODY THAT WAS INCREASING IN SIZE. MOM BROUGHT HER TO CLINIC FOR US TO SEE. ADVISED MOM TO TAKE HER TO THE DOCTOR RIGHT AWAY OR THE EMERGENCY ROOM IF RASH GOT WORSE.
MY TINNITUS IN BOTH EARS BECAME WORSE. THE LEFT EAR HAS MOSTLY SUBSIDED BUT MY RIGHT EAR IS NOW BOTHERSOME.
Patient received vaccine at 5:45pm and then started feeling dizzy, throwing up and shaking.
On the evening of my vaccine my left arm became swollen and painful. I then became nauseous, had a high fever of 100 degrees Fahrenheit and suffered from a migraine in the front sinus cavity all night. The next morning of the 27th my symptoms persisted, now accompanied by body aches, specifically my hip flexers were very sore and I was exhausted all day. by the morning of the 28th all symptoms subsided.
I was helping down in walk-in's tonight where typically immunizations are given by all clinical support staff (CSS) instead of paging the Imm's Specialist. Patient was due for his second doses of MCV4 and Hep A. I confirmed the dose, insurance's and made sure I was pulling from VFC correctly with another CSS. When I pulled from the box of vaccines in the fridge the boxes facing me were the pre-drawn up vaccines, and right there in big letters was, HEP A. So, I took the pre drawn hep A out of the box, and got the correct MCV4. Gave the vaccines. Everything went very smoothly until I went to document the vaccines and I couldn't find the lot number in the list the EHR was giving me. When I walked back down and looked into what box the I pulled from, I pulled the pre drawn Hep A, that is 1.0 mL, not 0.5 ml that the patient was supposed to receive. So, I gave the patient 1 mL of Hepatitis A in his right arm, along with MCV4, in his right arm. The patient had left by the time I had realized my error. I notified Manager On Duty. I also sent an email to RN and my manager. As of Friday night, the patient had not been notified. I contacted the patient on 5-15-2018 and informed him of the adult Hepatitis A vaccine that he received. Teaching was done. Patient had no complaints.
My son only received one shot that day (DTap), so we know the reaction was to that shot specifically. He received the shot on 8/27 in the afternoon. He complained of headache and soreness that evening and the next day. It wasn't until the evening of 8/28 that I noticed his arm when I changed his shirt for bed. It was very red, and very firm. It felt hot to the touch. His arm had swollen to twice it's size. He had a fever around 100 degrees. We called the nurse on call and asked what we should do. I was concerned because of his reaction to mosquito bites. The swelling starts and then stops on day 3 before going away with bug bites. At this point (with the shot), we were a little over 24 hours past the shot. I was concerned if the swelling would continue. We were told to wait. I gave him Ibuprofen. Woke him 6 hours later and gave him TYLENOL. We immediately called the Dr when the clinic opened and they got us in that morning. We saw the Dr. The swelling had gone down a tiny bit. He did an overall checkup. We were sent home to ice his arm and wait it out. He was better within a couple of days.
Fever (100), chills, intense body ache and head ache requiring sick leave the following day after vaccination
Henoch-Schonlein Purpura. Fever beginning 10/12. 10/13- fever persisted, 2 episodes of vomiting. 10/16 at 3 pm- rash noticed on lower extremities and buttock, bilateral knee pain with inability to ambulate. 10/17- rash worsening, swelling of knees bilaterally with increased pain, new onset abdominal pain, presented to ED and diagnosed with HSP, admitted to inpatient unit x 1 day.
Patient was given an expired vaccine, vaccine expired at 1230pm, and was given at 152pm, patient was contacted and came in 3/5/21 to be revaccinated.
SHOOK VIOLENTLY AFTER 48 HOURS AFTER SHE TOOK VACCINE; This spontaneous report received from a parent via a company representative 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, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced shook violently after 48 hours after she took vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shook violently after 48 hours after she took vaccine was not reported. This report was non-serious.
Bell's Palsy; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 (batch/lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date (reported as after about 9 days), patient began getting symptoms of Bell's Palsy. It got worse and he went to the doctor on an unspecified date and they did confirm that he has bell's palsy and they believe it came from the COVID vaccine. Patient would like to know should he get his second dose on 23Mar2021. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX 2 month before the time the time of reporting and experienced sore arm which had resolved. The reporter did not want to provide additional information. The case has been linked with case US2018203338 for 2nd dose of SHINGRIX.
Redness, swelling, slightly warm to touch approx. 15x8 cm. Also noted a bruise to injection site. Pt's mother stated pt was fine after vaccines were administered but in the morning she noticed some redness to the area. After school, the redness had spread and was swollen. Pt's mother brought pt to clinic on 9/27/18 at 5:00pm to be seen by RN and provider.
Lightheadedness started about 30 minutes after vaccine and lasted for about 6 hours. Nothing major, but reporting for completeness.
Fever up to 102 degrees, left deltoid 2+ swelling 1+ erythema.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/7/22 at approximately 11:10am. When error discovered facility contacted for course of action. At direction of the, patient contacted regarding occurrence to offer re-vaccination of dose. Patient declined revaccination. No adverse side effects or event as result of dose reported.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 05-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
This case was reported by a physician and described the occurrence of blurred vision in an adult male subject who was vaccinated with ENGERIX B. On unspecified dates, the subject received the 1st and 2nd dose of ENGERIX B (unknown). One day after vaccination with ENGERIX B, the subject experienced blurred vision. The physician reported seeing the subject who received two doses of ENGERIX B and experienced blurred vision the following day after receiving ENGERIX B both times. The physician was no sure when the doses were given but stated the 3rd dose was due 17 November 2008 and they were following the 0, 1, 6 month dosing schedule. The immunization series was discontinued. At the time of reporting the outcome of the events were unspecified.
Received 3rd dose, not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Received 3rd dose, not immunocompromised) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history information  was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (Received 3rd dose, not immunocompromised). At the time of the report, OFF LABEL USE (Received 3rd dose, not immunocompromised) had resolved.            Concomitant medications included chronic hormones as the patient was a transgender.  The treatment information was  not provided.  It was reported that patient received the third shot of vaccine  from a pharmacy and then scheduled her for a  fourth shot on 09-Sep-2021. She didn't  present her initial vaccination card upon receiving the third dose, and stated that  she did not qualify as immunocompromised.
Vaccine given on 01/31/22. Appointment made through agency who provided translation assistance at that vaccine clinic. Called agency on 04/29/2022 at 11:52a. Agency reports that he was a walk-in that day requesting J&J. Stated that they didn?t have a DOB on file for him. He is not a regular client of agency, and they were not familiar with this client. Stated that they would call the patient for translation assistance and to determine his age. Agency called and visited the residence on 4/29/22 and was told that he was not living at that address. On 4/30, Agency continued to try to call and text the client. On 5/01/2022, Agency was able to reach the patient by phone, who stated he did not know that he could not get J&J under 18 years old. He stated that he felt fine after the receiving the vaccine and that he has felt fine since then. Discussed with RN that provided the vaccine on 01/31/2022 and states that she cannot recall this incident or this patient.
Rash started on face then spread to the entire body. Rash is not itchy. No fever, runny nose, congestion, cough or sore throat. Diffuse rash started about 10 days after MMR vaccine given. Petechial rash isolated to nose. Parent's advised to watch and call if any worsening/spreading and blood work will be ordered.
This spontaneous report as received from a pharmacy technician refers to a 3 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 25-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.