chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. was requested to be vaccinated in the "high risk clinic" due to PMHX and concerns after the 1st vaccine.  Apparently after 1st vaccine had persistent cough for days.   Pt. presented for 2nd vaccine and vaccine was administered at 12:31p.   Shortly after vaccine, she developed chest tightness, felt like her throat was closing and SOB at 12:42 p.  Vitals B/P 145/88, Pulse 104, Resp 28, O2 sat 96%.   She was asked to take 2 puffs of her albuterol inhaler and I administered epi 0.3 mg IM to R. thigh at 12:44 pm and Benadryl 50 mg IM to right deltoid.   Medical First response was activated and responded within 2 min.   She was immediately transferred next door to the ED under the care of Dr. In ED Decadron 10 mg IV and additional diphenhydramine 25 mg IV, and Famotidine 20 mg  was administered.  She was discharged home later that afternoon with course of po decadron and epipen.  2/5/21- Pt. is not returned to work d/t continued SOB and continues to f/u with PCP.
Experiencing very painful left shoulder blade extending up to elbow. Can't sleep on her left side. Worse at night. Tried heat and cold compress. NORCO and TYLENOL with no much help.
This spontaneous report as received from healthcare workers refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9, lot # L007560, expiration date: 15-JUN-2017, (dose, route of administration and injection site were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
16 year old inadvertently received the vaccine; sore arm; supposed to receive the Pfizer vaccine but received the Moderna covid-19 vaccine by mistake; A spontaneous report was received from a healthcare professional (HCP) concerning a 16-year-old, female consumer who received Moderna's COVID-19 vaccine  (mRNA-1273) was less than 18 years old and had a sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 06 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number : 025J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 06 Jan 2021, a 16-year-old patient was inadvertently vaccinated. The patient was supposed to receive Pfizer vaccine but received Moderna COVID- 19 vaccine by mistake. The patient experienced a sore arm but no other known symptoms. No treatment was received for the sore arm.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, vaccine given to a patient less than 18-years-old, and wrong drug administered was considered resolved. The outcome for the patient's sore arm was not reported.; Reporter's Comments: This case concerns a 16-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age and Wrong product administered with an associated non-serious expected event of Injection site pain. No treatment received for the event. Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.
Skin abscesses developed in left thigh vaccination site which ruptured, drained and healed over 2 weeks.
I had the two shot shingrix vaccine as reccomended by my doctor.   The first dose in Pharmacy was no eventful.  The second vaccine at the Pharmacy has caused sever side effects.  Started with immediate swelling in my right arm followed by soreness in my right shoulder and neck.   The arm pain and shoulder pain are gone but my neck pain continues.   Plus i have a tingling sensation up my neck and into my ear five or six times a day.  Also I seem to be very fatigued all day which is affecting my ability to do normal things like playing golf, which I do 3 or 4 times a week.   I have never had a reaction to a shot at all.  In my opinion the side affects of this vaccine outway the benifit.  Do you know what I can do to help?  Thanks,
staff gave only the liquid portion of Pentacel with no reported adverse event; Initial information received on 15-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and gender patient to whom staff gave only the liquid portion of 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.  On an unknown date, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (batch number, expiry date, dose number unknown) via unknown route in unknown administration site for prophylactic vaccination (immunisation), only the liquid portion with no reported adverse event (wrong technique in product usage process) (same day latency). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event staff gave only the liquid portion of pentacel with no reported adverse 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.
Not feeling well; her appointment for the second dose is today,but is unable to go; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (Lot number: EW0162, Expiration Date: 31Jul2021) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Not feeling well"; PRODUCT DOSE OMISSION ISSUE (non-serious), outcome "unknown", described as "her appointment for the second dose is today,but is unable to go".  Additional information: The patient wanted to know when the latest day was to get her Pfizer COVID-19 second dose. Caller stated she was not feeling well and wants to reschedule her second dose. Caller also stated she received her first dose 04/16/21 and was scheduled this Friday for her second dose. Caller also wanted to know if the batch number or serial number on the vaccination card is the actual vial that of the COVID-19 vaccine.   No follow-up attempts are possible. No further information is expected.
Flu like symptoms, all over body aches, fever of up to 103.2 which has been ongoing for about 5 days now, loss of appetite, symptoms are finally subsiding.
Breakthrough COVID infection. Patient fully vaccinated 2/3/2021. Patient tested positive for COVID on 8/24/2021.
The vial was initially stored in the refrigerator on 03Oct2022, BUD was reported as 02Nov2022 and was administered on 11Nov2022; Temp Excursion - Yes; No adverse event; erroneously vaccinated clients with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03Oct2022, BUD was reported as 02Nov2022 and was administered on 11Nov2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion - Yes) and NO ADVERSE EVENT (No adverse event) in a 52-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated clients with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03Oct2022, BUD was reported as 02Nov2022 and was administered on 11Nov2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion - Yes) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03Oct2022, BUD was reported as 02Nov2022 and was administered on 11Nov2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion - Yes) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03Oct2022, BUD was reported as 02Nov2022 and was administered on 11Nov2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion - Yes).    No concomitant medication were reported.  It was reported that the patient was administered dose after 30 day use by date. The size of the vial was 2.5 ml. The vial was initially stored in the refrigerator on 03-Oct-2022 and was administered on 11-Nov-2022. Beyond use date was reported as 02-Nov-2022. The vial underwent temperature excursion. 9 days past expiry date the patient received the vaccine. No treatment information was provided by the reporter.   This case was linked to MOD-2022-681291 (Patient Link).
This is a spontaneous report from a non-contactable consumer reporting for herself. This female patient of unknown age received in Jul2016 a single dose of PREVNAR 13 for the prevention of pneumonia.  The patient medical history and concomitant medications were not reported. In Sep2016, in the week before this report, the patient reported that developed pneumonia. Her doctor told her that she had fluid in her left lung and it looked like pneumonia. Outcome was unknown. No follow-up attempts are possible. No further information is expected.
Adult patient received a peds dose of the Hep B instead of an adult dose.  Dose in medical record needs to be documented as invalid.  pt will be contacted.   No adverse event occurred  Pt did also receive a correct dose of Hep A adult the same day. No adverse event occurred.
erythema mult, minor seen 7 days p/vax;rash started 5 days p/vax;
Presented with dec appetit, lethargy, confusion; dx with covid 2 weeks prior; dx in ED: hypoxia secondary to Covid PNA and possible aspiration: labs: D-dimer 5.09; CRP 27.2; Ferritin 2009; CXR: Bil opacities likely representing multifocal PNA  Tx: No remdesivir due to out of admin window; rec'd steroids, IV antibiotics, Vit C, Vit D3, Lovenox, Zinc; Initially on NRB Mask, 15 LPM; down to 4 LPM at d/c
Pt. began c/o back neck pain.  This increased to shortness of breath and dizziness.  911 was called. Pt began vomiting.  She was transported to Hospital per squad.  Awake, alert and oriented, breathing w/o difficulty.  Called pt 09/07/21 for FU.  Pt has a history of HTN, she takes "aspiring 81mg to control HTN"  Pt was 8 weeks pregnant at the time of vaccination.  Due delivery date: 01/27/2022.  Pt denies knowing the weight of the baby.  Pt was told by her PCP to not take the second dose of Moderna vaccine. Pt. verbalized understanding.
Patient was fully vaccinated. Doses on 1/14/21 and 2/4/21. Diagnosed with COVID-19 on 6/21/2021 and passed away on 7/3/2021.
I got my second covid-19 dose on April 9th. I was supposed to start my period on April 16th and skipped it. I did not start my period until May 2nd and bled until May 9th, 2021. If my period was on track/normal flow I would have started again on May 28th -30th but didn't start bleeding again until June 7th-10th (what I thought was my normal period) ended up being a very light/abnormal bleeding. I spotted June 11, 12,& 13th- then I started bleeding again continuously June 14th- July 15th, 2021 (still bleeding). I have had continuous cramping and body aches  April 12th, 2021 (period symptoms).
24 hours after my vaccine, I felt a swelling in my armpit. I can only feel it when my arm is down. A few days later, the left side of my neck swelled up and my ear felt plugged up I also had sore throat and I couldn't hear out of the left ear. I used over the counter ear remedies and ibuprofen but I lost hearing in both ears eventually and my entire neck was inflamed. I went to see the doctor and he didn't prescribe me any medications so I used google and I read to keep taking ibuprofen and after about four days I started to feel much better.
I have never had any issues with memory, short term memory or cognitive function. Over the past month I am DAILY unable to recall familiar names multiple times a day and find myself searching for words. I feel like a bit of a fog has set in at times. (note: upon receiving the first shot, I had sharp tingling and prickling sensation in my lips for approx. 12-15 hours)
Pt reported noticing redness/swelling by right deltoid at around 8-9pm on 9/13/19 (day of administration). Reported it being very itchy and slightly hot to the touch. Came in to report this at around 2:30pm on 9/14/19 . Right arm was still slightly swollen and per pt, swelling is moving slowly down arm from area of vaccine administration to bicep area.
Sore/painful arm persisting since the vaccination on 11/27/07. Must take medication to relieve pain and unable to apply pressure to arm. Will see doctor soon.
pt reports having a rash and swelling in her left arm below the injection sites starting one day after immunizations. Rash and swelling extended from just below injection sites in left deltoid around her upper arm and down past her elbow. pt reported that she was seen in the local ER where the provider instructed her to take Benadryl and ibuprofen. no further treatment was needed. no lasting side effects were reported. patient called this health department on 10/29/2019 to report adverse event.
Covid vaccine site:   Per chart pt received covid vaccine at 1413 accompanied by his Grandma.  About a minute later, pt had a syncopal episode while walking to observation area.  Per grandma, pt hit L-side of face on plastic chair.  Medical staff responded to incident, RN and Dr, pt supine on ground - awake and alert.  Dr examined pt.  VSS taken:  BP:  130/60 HR: 74 O2sat:  99% RA.   1420: With permission from Dr, pt stood up to sit on the wheelchair.  Pt wheeled to observation/triage area.  Intervention:  Ice and gauze dressing.  Pt is awake and alert, mild swelling to L side of-face, under eye - small break in skin noted, bleeding controlled.  Pt had some juice, water and crackers, no difficulty swallowing.  Pain 2/10, tolerable.  Cold compression on and helping.  Grandma remains with pt - per grandma, pt has history of passing out with blood draws.   1440:  Pt remains awake and alert, NAD, no new or worsening complaints.  Grandma remains at bedside.   1505:  Orthostatic BP done per Dr.  Results given to MD.  No new orders.   1510:  Dr OK'd pt to go home with grandma.  Grandma and pt stated they are comfortable to go home.  Instructed pt and grandma to monitor for symptoms and to call PCP or 24 hour advice line for new or worsening symptoms.  Call 911 or go to emergency if has emergent symptoms.  Grandma and pt verbalized understanding and agreed.  Pt and grandma exited triage area, ambulatory with steady gait and in no apparent distress.  Grandma will drive pt home.
Acute schizophrenia, stiff, sore, dyskinesia, high blood pressure medication - insomnia, rash, disabled - sick, vomit, blurry.
On the 23rd of June, I had a fever and body aches.  I also had the fever on the 24th.  I had a fever still on the 25th.  I spoke to my doctor and they told me to ride it out until Sunday. My fever broke on Sunday.  It has returned since then it is still 100 degrees as of today.  I also dizziness and nausea which have not gone away.
Leg swollen; red and 3 in x 4 in area- warm to touch. Today blisters on leg. Using MOTRIN and ice on leg.
I have Friends that got the shingles shot 11 of them now have shingles/ Suspected Vaccination failure; I have Friends that got the shingles shot 11 of them now have shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have Friends that got the shingles shot 11 of them now have shingles/ Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have Friends that got the shingles shot 11 of them now have shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUL-2023 This case was reported by a patient's friend via interactive digital media. The patient got shingles shot and now he/she had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This was 1 of 11 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR104620:same reporter US-GSK-US2023AMR104628:same reporter US-GSK-US2023AMR104626:same reporter US-GSK-US2023AMR104625:same reporter US-GSK-US2023AMR104621:same reporter US-GSK-US2023AMR104623:same reporter US-GSK-US2023AMR104624:same reporter US-GSK-US2023AMR104627:same reporter US-GSK-US2023AMR104617:same reporter US-GSK-US2023AMR104619:same reporter
11/21/06 seen for URI, 11/27/06 fever unknown illness, 11/29/06 to ER for listlessness, 11/30/06 admitted for viral meningitis, 12/05/06 transferred to NICU for truncal ataxia. 12/07/06 d/c home, normal CT, no growth on CSF x2, Abnl MRI. 01/08/07-records received and reviewed.  DOS 12/1-12/5/06 DC DX: from Methodist Hospital. Began with FUO, progressed to listlessness and not responsive, not looking at people. CSF: WBC 100 with glucose and protein studies consistent with meningitis. IV Rocephin, vancomycin and acyclovir. CSF cultures negative, PCR HSV negative, CXR mild bronchitis. Allergic to vancomycin. IV treatments discontinued. However, clinical picture did not rapidly improve. CT essentially negative. Suspected possibility of partially treated bacterial meningitis and repeated LP showed 0 WBC, slightly decreased glucose and protein in range of 60s. Restarted on acyclovir and Rocephin. Afebrile throughout stay. PE: nucal rigidity, truncal ataxia and drooling. Transferred to Sutter Hospital. records requested.  01/16/07-records received and reviewed from Sutter Memorial . DC Summary for DOS 12/5-12/7/06 DC DX: Viral meningeal encephalitis MRI no mass or hydrocephaly. Abnormal signal bi-thalamic and bilaterally in basal ganglia. This can be due to ischemic hypoxemic, infectious , inflammatory demyelinating causes. The absence of definite diffusion abnormality suggests that acute ischemia is not the explanation. Differential diagnosis is ischemia, infection, demyelination. Admitted with truncal ataxia and no feeding and fevers.  RX with acyclovir, ceftriaxone and vancomycin. Developed red man syndrome with vancomycin
I began experiencing swelling around bone on outside of left wrist bone and after that increasing pain in that area and around the thumb on same hand. After x-ray and MRI on that hand confirmed arthri; This is a spontaneous report from a contactable consumer. A 81-years-old male consumer (patient) reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL9264) via an unspecified route of administration on 13Feb2021 at 11:45 in left arm as a single dose for covid-19 immunization at hospital. Medical history included arthritis in neck, psoriasis and irritable bowel syndrome all from an unknown date and unknown if ongoing, left knee replacement in 2014. The patient previously took celebrex for drug hypersensitivity. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot Number: EL3249) on 23Jan2021 at 10:00 in left arm for COVID-19 immunization. Concomitant medications received in two weeks included finasteride (FINASTERIDE), gabapentin (GABAPENTIN), levothyroxine (LEVOTHYROXINE) and magnesium (MAGNESIUM) all taken for an unspecified indication, start and stop date were not reported. On an unspecified date in Mar2021, the patient experienced swelling around bone on outside of left wrist bone and after that pain increased in that area and around the thumb on same hand. X-ray and MRI confirmed arthritis that hadn't been evident before Covid-19 jabs. He also experienced some pain in left elbow and outside bone on right wrist and left hip bone discomfort had intensified into sharp pain at times. Bone density test showed normal range. Therapeutic measures were taken, and patient was treated with steroid injection in left wrist (zero help). The patient underwent lab tests and procedures which included magnetic resonance imaging and x-ray which confirmed arthritis and bone density test showed normal range. The events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered.
Cancer / maybe it was Multiple Myeloma; Multiple Myeloma; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced cancer (serious criteria GSK medically significant) and multiple myeloma (serious criteria GSK medically significant). The patient was treated with acyclovir, lenalidomide and dexamethasone. On an unknown date, the outcome of the cancer and multiple myeloma were unknown.   It was unknown if the reporter considered the cancer and multiple myeloma to be related to Shingrix.  Additional details were provide as follows: After vaccination, the patient started taking medications for Cancer. The pharmacist did not provide lot number and expiration date of the first dose because it was administer in another pharmacy. The pharmacist was not sure of the type of cancer, she thought that might be it was Multiple Myeloma.  She mentioned that the medications were Lenalidomide, Dexamethasone, Acyclovir and another one which name was not clear. The pharmacist wanted to administer the second dose before the patient started with chemotherapy. The reporter consented to follow up.