chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician refers to a 61 year old male patient. The patients medical history included bacterial meningitis 20 years ago. The patient had no drug allergies or reactions. on 13-MAR-2013, the patient was vaccinated with a dose of 0.65ml ZOSTAVAX, (lot number, expiry date was not reported, route was subcutaneous) in the left arm. Concomitant medications were not reported. On 25-MAR-2013, the patient developed pain, tingling and weakness of his left arm after receiving ZOSTAVAX. The outcome of the event was reported as recovering. The patient sought medical attention (phone call to physician). Additional information has been requested.
On 09/22/2022 at about 01:15 pm, the Chief Nursing Officer (CNO) at the local Hospital illegally scanned her badge at the pharmacy door and gained access to the pharmacy to retrieve COVID-19 (Moderna Bivalent) vaccines. When the CNO was informed by the pharmacist that she (CNO) had illegally gained access to the pharmacy, the CNO replied that since she (CNO) was the boss of the pharmacist and supervised the pharmacist, she (CNO) could scan her badge to the pharmacy door to gain access to the pharmacy. The pharmacist then reported the matter to the local State Board of Pharmacy. The CNO retrieved one 2.5 mL vial of COVID19 Moderna Bivalent vaccine and administered to patients. See information below
temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect product storage in a neonate female patient who received HBV (Engerix B) for prophylaxis.   On 30th July 2021, the patient received the 1st dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.  Additional details provided were as follows: Age at vaccination was not reported. Nurse reported that, the new born received a dose of Engerix B after a temperature excursion where the vaccine was expose to freezing temperatures (8 by 20 to 1.4 degree Celsius for 1hr and 8 by 23 to 26.4 degree Celsius for 4 hrs) The reporter consented to follow-up.; Sender's Comments:  PR-GLAXOSMITHKLINE-PR2021168130:FU deleted
Immediately after receiving the second dose, the colleague noted significant swelling at the injection site. No pain noted.
Dizziness armpain at injection site Narrative: Per nursing report: "received his 2nd dose of the Moderna vaccine on 8/25/21 and called today[8/26] to report adverse symptoms of dizziness. and right arm pain. Employee report that he is unable to raise his right arm due to injection sire soreness."
Immunization 6/7 pm. Child developed bumps with which center over head, face, ears, red puffy eye, runny nose 6/10 at 12 noon. Mother called Dr - gave BENADRYL - lesions lessened by afternoon. Child fussy/warm. Mother did not check temp - By evening. No symptoms.
After the injection I had a severe erythema redness to my right arm. I also had soreness and swelling to the right arm. I had a fever of 102F. I had  severe malaise and body aches as well as headaches.
The patient after receiving his vaccine, was recommended to take a seat for 15 minutes to observe for any adverse reactions. Very shortly after the shot, he walked up to the counsel window to ask for a bottled water because he was starting to feel faint. As I was trying to suggest he immediately take a seat, he fainted and fell forward into the immunization booth which absorbed most of his fall as he went to the ground and landed almost sitting cross legged. Immediately myself and pharmacy staff laid him flat onto his back and raised his legs above his head where he regained consciousness immediately and stayed laying down for a period of time to make sure he was feeling okay. After a few minutes we gave him a bottled water and had him sit down for 15 more minutes where he claimed he was feeling much better.
Intermittently nauseated; vertigo; Head started feeling heavy; This is a spontaneous report from a contactable non health care professional, the patient. A 48 year old female patient received first dose of BNT162B2 (Pfizer BioNTech Covid 19 MRNA VACCINE BIONTECH) (Lot/batch no: EN6207) solution for injection via unspecified route of administration at left arm on 10Mar2021 as single dose for COVID-19 Immunisation. Medical history included allergy to sulfa, PCN (Penicillin) and shellfish. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included Wellbutrin for unknown indication. Past medication was not reported. On 14Mar2021 the patient complained of her head started feeling heavy and she became intermittently nauseated with vertigo. The patient was not tested positive for covid-19 since vaccination. The clinical outcome for the events Head started feeling heavy, intermittently nauseated, vertigo was recovering at the time of reporting. Consent was given to contact the reporter. Consent was not given to contact Health care professional. No follow-up attempts are needed. No further information is expected.
After first dose, pt had persistent L deltoid pain. Within 24h after second dose, she had fever and worsening redness and swelling of the L deltoid. She eventually was admitted and found to have a sub deltoid bursitis that required incision and drainage. Fluid was inflammatory but cultures off of antibiotics remained negative.
On 12/24 I developed hives and itchiness. It spread to my face and was still there a week later. I went to my PCP around Christmas time so she referred me to a Allergists. Was taking Zyrtec and QVAR inhalers.
Subject in pneumococcal vaccine trial, with severe COPD died of respiratory arrest on the way to the hospital. According to the physician, relationship to treatment is 'None'. We would be happy to forward the Study's SAE Report Form upon request.
received Engerix intravenously during a dialysis; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B (intravenous inf). On an unknown date, unknown after receiving Engerix B, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.    Additional Information: GSK receipt date: 02-Sep-2022 Reporter's comment: A pharmacist reported on behalf of the physician that a patient received Engerix intravenously during a dialysis infusion. No symptoms reported. The reporter did not have any patient or vaccination details. Reporter did not consent but neither declined consent; only replied by saying she did not have any further information. Additional supportive information: Patient received Engerix B intravenously rather than intramuscularly as per vaccine schedule, which led to intramuscular formulation administered by other route.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patient's involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 29-APR-2013 (lot # H011350, Expiration Date: 21-FEB-2015). No adverse event was reported. This is one of the report from the same source, linked reports. Additional information is not expected.
Waited 30 minutes after injection, was fine. Almost immediately after I left I started feeling numbness around my lips. Within minutes my gums started feeling numb. Then my whole face felt numb. Not extreme - Not like Novocain at the dentist, but definitely strong enough to cause concern. I was on the fence about calling a doctor, but it seemed to level off. My face and lips remained numb for a couple of hours. Gums were not too bad. It didn?t completely go away until well into the evening.
Tingling in thumb first finger and middle finger, then entire hand then forearm. Came and went within the first hour.; This is a spontaneous report from a contactable other healthcare professional. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 14:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 13Apr2021 at 14:30, the patient experienced tingling in thumb, first finger and middle finger, then entire hand and then forearm. It came and went within the first hour. The clinical outcome of the event tingling in thumb, first finger and middle finger, then entire hand and then forearm was recovered on an unknown date in 2021.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
SWOLLEN /RED FACE, HIVES, PRESSURE, SLIGHT DIFFICULTY BREATHING
pt vaccinated on 2/19/2021  admitted to hospital on with covid 19 complication on 6/19/2022  passed away on 06/26/2022
Went to a vaccine administration center. The vaccine was given high and pain shot up from shoulder into my neck and head. Muscle was not punched to assure needle didn't go too far in. Arm had expected soreness for a few days. Then 2nd shot 5/6/2021 - swelling began under the arm pit and in lymphnodes in the collarbone. Swelling spread to surrounding muscles and there's compromised used of the arm. Referred pin beginning in neck and upper back and forearm and wrist. Spending a lot of money getting test and treatment. Physical therapy, doctor visits, acupuncture and massages to try to relieve the issue now 6 months later. Cannot fully use the arm-pain and weakness.
Pt recvd vax on 21JAN92 & appeared fine & verbalized that was OK then sat in chair fell to floor, unresponsive & rigid w/pale x 20-30 seconds;
Pt. states that after receiving 1st dose of Phizer 07/21/2021, started experiencing a swelling in the right side of the neck 07/22/2021 painful to the touch. Still continuing to swell, no noted Primary visit.
Could not move arm the next day. I called to report the adverse event. Noticed later swelling and bumps around injection site.  3 weeks later the redness and bumps are still there.  Terrible allergic reaction.  Was told by pharmacist to buy over the counter medicine for adverse reactions.
Myalgia, NauseaVomiting, burning pain right side body, losing voice, fatigue Narrative:
My hearing in my right ear is not as good asbefore. Burping clears it then shortly after the same. Kinda like when your on a plane then your eardrum eventually clears
Began having welps approximately 18 hours after the vaccine, which continued to appear for the next several days.  They ultimately blistered and were diagnosed as shingles by a physician on day 5.
Complaints of soreness at injection site which travelled down her arm to her elbow, causing joint pain. Still having symptoms after 4 months.
On December 9 I started having symptoms of a cold - scratchy and sore throat primarily.  Over the next two days the symptoms increased and included sinus congestion, sore throat, severe dry cough, headache, tiredness and low grade fever 99.5- 100 F.  On December 10 I tested negative for Covid with a home test, but on December 11 the test was positive.   I contacted my family practice provider by telephone on December 12 and 13  was prescribed Paxlovid for 5 days starting December 13.   Symptoms started to resolve  slowly on December 14.  On December 16 my home covid test was still (faintly) positive.   On December 19 the home Covid test was negative.  I still have some minor sinus congestion and cough as of December 23.
Pt recvd vax & devel pain @ the inject site which lasted aobut 7 to 8 mins a/resolving; pt also c/o sore & heavy arm all day;
She got her vaccine, she did not have any reaction that day.  Her arm hurt a little when she was sleeping.  She woke up the next morning and had severe chest pain, which did not stop no matter what she was doing during the day, even sitting down.  The following day when she woke up everything was back to normal.  She waited one additional day to make sure it was not a microvascular issue she had, and did not get it again and still does not have any  issues.  She did call her cardiologist who told her not to take the 2nd vaccine.   The day they were going on she just took her regular medication and monitored her heart rate and her BP.
Severe pain and swelling to upper arm. Nausea and vomiting during the night. Took ADVIL; applied ice pack, slept intermittently. Severe pain has subsided but still very sore.
Patient came in for first Pfizer vaccine, denied previous adverse events to any vaccines. Shortly after vaccine administration patient started feeling nauseas and experienced dizziness along with vision changes. Patient laid on the ground with feet up and paramedics were called as the patient was turning pale. She was evaluated by paramedics, felt fine, and denied their assistance.
Dizziness, headache, nausea, congestion, fever, weakness, shortness of breath,
This spontaneous report as received from a physician and the office manager refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (lot # K024036, expiry date 26-NOV-2016, strength, dose, route and site of administration were not reported). No adverse symptoms were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Inconsolable crying 7PM-7AM, fussy during day. Lump on right thigh around 4cm, no redness, no warmth and tenderness.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 31-MAR-2015, the patient was vaccinated with a dose oral, ROTATEQ (lot # K011663) (expiration date and dose were not provided). There was a 72 hours excursion for this vaccine. No adverse events have been reported. This is one of several reports from the same reporter. Additional information has been requested.
STROKE; BLOOD CLOT; OUT OF HIS GOURD; This spontaneous report received from a consumer concerned a 7 decade old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose were not reported, 1 total administered, start therapy date were not reported for prophylactic vaccination. 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 stroke, blood clot. As per reporter, patient was out of his gourd, but at the time of reporting patient was some what normal but patient would never be normal and also stated that the Janssen COVID-19 vaccine was 2 doses of mRNA. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot, stroke, and out of his gourd. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211014628 and 20211014552.; Sender's Comments: V0: 20211014652-covid-19 vaccine ad26.cov2.s-stroke, blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This case was reported by a nurse and described the occurrence of decreased therapeutic response in an adult male subject who was vaccinated with Twinrix for prophylaxis. On unspecified dates, the subject received the 1st, 2nd, and 3rd doses of Twinrix (unknown). Antibody levels were measured one to two months after the completion of the three dose series. The subject had hepatitis B antibody titers of less than 10mIU/mL.
DID NOT TAKE FIRST TWO DOSES OF VIVOTIF ON AN EMPTY STOMACH; This spontaneous case report was received from a pharmacist (PVX2019-033) on 04-Jan-2019. The report describes a female consumer who "did not take first two doses of Vivotif on an empty stomach". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer did not take the first two doses of Vivotif on an empty stomach. She took the third dose on an empty stomach.  The action taken with Vivotif with respect to the event "did not take first two doses of Vivotif on an empty stomach" was not applicable.  The clinical outcome of the events "did not take first two doses of Vivotif on an empty stomach" was unknown.  Company's Comment: The causality of the event "did not take first two doses of Vivotif on an empty stomach" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event  "did not take first two doses of Vivotif on an empty stomach" was considered as not applicable.
Atypical HSP-fever, bruising/petichiae/edema of legs. The hospital discharge summary states bilateral OM.  A follow up report received 8/26/03 adds: Atypical HSP - fever, bruising, peticular, edema of legs. Diagnosed with allergic reaction
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756550A, A0756552A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUACA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Fever (103); This case was reported by a physician via sales rep and described the occurrence of fever in a male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix at an unknown dose. On an unknown date, unknown after receiving Pediarix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Pediarix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received Pediarix and had fever.      Lab Comments: Lab test performed on unknown date
Patient is a 37 y.o. female with a history of left-sided weakness that occurred around 2 PM today patient states she was picking up her daughter from school and also began having some left-sided weakness upper and lower extremities well some tingling on the left side of her face she states symptoms persisted so she presented to the emergency room stroke alert was called neurology evaluated the patient was initiated on TPA as she was a candidate. She states symptoms have completely resolved at this point no nausea no vomiting no chest pain denies blurred or double vision patient states she tested positive for Covid February 1 is vaccinated and was asymptomatic during positive testing.
chills; bad headache for 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (bad headache for 12 hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and HEADACHE (bad headache for 12 hours). At the time of the report, CHILLS (chills) outcome was unknown and HEADACHE (bad headache for 12 hours) had resolved.            No concomitant medication was reported.  No treatment medication was reported.
Patient presents to the clinic with erythematous patch on left arm just below injection site, left upper arm noticed to be longer than the right and c/o low grade fever for 6 days, body aches.
Fatigue; diarrhea; weakness; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729), via an unspecified route of administration in the left arm on 07Apr2021 at 18:00(at the age of 19-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported and the patient did not have a history of allergies to any food or medications or other products. The patient did not receive any other medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021 at 13:00, the patient experienced fatigue, diarrhea and weakness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fatigue, diarrhea and weakness were unknown at the time of the report.   No follow-up attempts are needed. No further information is expected.
Pt reported nausea and vomited once approximately 10 min after vaccine. No other symptoms present. Pt given ice pack and water and reported feeling better.