chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered IPOL 0.1 ML intradermally instead of the ordered PPD test with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 29 years old female patient who was administered IPV (VERO) [IPOL] 0.1 ml intradermally instead of the ordered ppd test with no reported adverse event.  The patient's past medical history, medical treatment(s),  vaccination(s) and family history were not provided. Patient had no other concomitant medication.  On 25-Oct-2022, the patient received 0.1 ml, 1 X(once) dose of suspect IPV (VERO) (strength, formulation was unknown, lot V1B901M and expiry date: 02-Jun-2024) via intradermal route in the right forearm for Immunization.  On 25-Oct-2022 the patient developed a non-serious event of  was administered ipol 0.1 ml intradermally instead of the ordered ppd test (strength, formulation, route, administration site, batch and expiry date was unknown for prophylactic vaccination) with no reported adverse event (wrong product administered) (Latency: same day)following the administration of IPV (VERO).  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Discharge Provider: MD Primary Care Provider: DO Admission Date: 7/17/2022 Discharge Date: Jul 22, 2022  PRESENTING PROBLEM: COVID-19 [U07.1]   HOSPITAL COURSE: 79-year-old patient with a past medical history of nonrheumatic aortic stenosis, chronic diastolic dysfunction, coronary artery disease presented to the emergency department after a syncopal episode and was found to have acute hypoxic respiratory failure.  She was positive for COVID-19 A acquired 2 L of oxygen at the time of admission which was eventually weaned off to room air.  Patient was placed on telemetry which showed persistent bradycardia along with associated dizziness because of his cardiology was involved.  Patient underwent placement of dual-chamber permanent pacemaker on 07/21/2022 after which her symptoms significantly improved and resolved.  Patient was discharged home in a stable condition.
felt pressure in rt hand (fingers);then metallic taste in mouth;sore throat;lightheadedness, nausea (very brief) then red, itchy rash on fore arms, dry mouth, sore throat & metallic taste in mouth;
POTENTIAL ADMINISTRATION OF AN EXPIRED JANSSEN COVID VACCINE; This spontaneous report received from a health care professional concerned an 18 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown if patient was pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAY-2021, the subject experienced potential administration of an expired janssen covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potential administration of an expired janssen covid vaccine was not reported. This report was non-serious.
Misadministration --> inadvertently received PENTACEL and IPOL injections.
generalized rash noticed approximately 8 hours after receiving vaccine.lotion applied to rash at time noticed. called OMS on 1/23/09 to report rash and came in to OMS for treatment.  Received Benedryl 25mg orally after being examined by staff physician and was told to take Benedryl 25mg orally three times a day and Clarinex 25mg orall daily.
Narrative: Patient reported headache following administration of 1st dose of pfizer covid vaccine. Patient was released with no intervention.
Pins and needles sensations, numbness in back of legs and face, swollen face, vomiting, lasted around 3 weeks, broke in hives in the back of the leg, pin needles in arm left hand
Slight arm soreness at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the right arm on 01Mar2021 at 14:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient's 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 COVID-19 vaccine. Concomitant medications included loratadine (CLARITIN) and vitamin d nos (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received sulfamethoxazole/trimethoprim (BACTRIM) and experienced drug allergy. On 02Mar2021, the patient experienced slight arm soreness at injection site. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event slight arm soreness at injection site was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
This non-serious spontaneous case, initially received on 04-Dec-2017, reported by other health professional and concerns a 28-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 01-Nov-2017, the patient received FLUVIRIN Thiomersal (batch number: 1721001, expiry date: 31-May-2018, dose, route of administration, anatomical location: not reported). It was reported that, temperature was checked, and it was 39 degrees. Between 9:00 am to 5:00 pm, the temperature was 32-34 degrees. Upon adjustment the temperature went to 36 degrees (explicitly coded as incorrect product storage). It was stated that, one vial was administered after the excursion (explicitly drug administration error). It was confirmed that, MDV (unopened) reached down to 32F for 8 hours, it was the first-time excursion, six doses were administered, and the vaccine was not frozen. It was reported that, the patient did not experience any adverse events after the vaccination. Non-significant case correction received 04-Dec-2017: The expiry date of the suspect product was corrected from May-2018 to 31-May-2018. The narrative was amended accordingly.
Pt claims to be flushed, cold feeling, sore throats starting +- 5 hours after vaccine administration. Left shoulder joint in particular was painful. #8 pain level. Pt used TYLENOL and a heating paid which helped to resolve the pain. Could not sleep. Did not seek medical help.
got the vaccine and he got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were reported as follows: The patient was the reporter's co-worker. The age at vaccination was not reported. The patient got the vaccine and about a month or so later, he got shingles/ The reporter was just curious if it was related or not. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Received initial anthrax vaccination at about 0830. 8 hours later felt lightheaded and hot. Awakened next morning at 0530; in standing had vertigo, which resolved in under 30 seconds. Mild occipital and retroorbital headache persists bilaterally.
Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Mild, Systemic: Weakness-Mild, Additional Details: Patient stated she had similar reactions when she received her first two doses of this pfizer vaccines. This incident occured upon giving her the third dose of pfizer. Ambulance was called in and the patient was transported to the Hospital (ER). However, patient did come back to the pharmacy to let us know that she was treated and feeling better after being discharged from the Hospital.
FEVER, CHILLS, COUGH, FATIGUE, SINUS DRAINAGE,  MAB TREATMENTS
5 days post vaccine patient developed foot swelling/rash.  Seen by PCP 4/20/21 for this issue and diagnosed with rash/vasculitis like reaction.
Pneumo vaccine given in am on 10/23/06, in afternoon, pt noticed swelling, tenderness. Came to clinic on 10/24/06, re upper arm, red, swollen tender to touch. Seen by DR. Recommended ice pack, Tylenol, Ibuprofen. Call us in 48 hours.
severe hives throughout body, swelling of eyelids, urticaria. Exacerbation of eczema. Parents administered Benadryl. Was seen the following  incident.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (received 1st dose on 12th September 2018, refer case US2019040249). On 9th November 2018, the patient received the 2nd dose of SHINGRIX. On 10th November 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, muscle pain, erythema, swelling, tenderness and influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, muscle pain, erythema, swelling, tenderness and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the injection site pain, muscle pain, erythema, swelling, tenderness and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and following day after shot, she experienced a sore left arm and muscle aches feeling like the flu. The muscle aches lasted a day. The sore arm lasted 4-5 days. There was a golf ball sized raised red spot that was swollen and sore to touch. The golf ball size circle was describing the red area not the swelling. The reporter gave consented to follow up. This case linked with US2019040263 and US2019040249, reported by same reporter.
PT STATES THAT THEY ARE NOW 3 WEEKS OUT FROM VACCINE ADMINISTRATION AND STILL EXPERIENCING INJECTION SITE PAIN (LEFT ARM). PT REPORTS PAIN IS EVIDENT AT REST THROUGHOUT THE DAY BUT DOES NOT CHANGE WHEN THEY ROTATE ARM. PT DENIES ANY BRUSING. PT HAS TRIED ORAL NSAIDS WITH MODERATE RELIEF. RECOMMENEDED PT TO SEE PCP FOR EXAMINATION. STATES THEY WILL SEEK MEDICAL ATTENTION IF PAIN CONTINUES TO PERSIST AN ADDITIONAL WEEK.
I had tachycardia about 18 hours following my second dose. It lasted a few hours before subsiding. I had this along with aches, headache and fatigue which I expected but the tachycardia was pretty significant. Up and walking to the bathroom HR was in 130s, laying down it was in the 110s.
Patient presented to emergency department on 11/30/2021 with shortness of breath. She was found to be COVID-19 positive. Patient was treated with dexamethasone, remdesivir, baricitinib and supplemental oxygen. Patient was transferred to the ICU on 12/6/2021 and was intubated on 12/7/2021. Patient coded during intubation and went into cardiac arrest. Patient expired on 12/7/2021.
Pt has history of hearing loss and uses aids. Within 3 d of taking vaccine had significant loss of hearing. No pain, h/a, bleeding. No trauma.
HALLUCINATIONS; This spontaneous report received from a patient concerned 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 not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered in right arm on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient reported that she was concerned because she was seeing things she knew wasn't there (out of the peripheral of her eye). It was reported that she was hallucinating from afternoon of 09-Apr-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hallucinations. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421275-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Hallucination. This event is considered unassessable. The event 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.
FEVER, SWEATS/CHILLS, FATIGUE, FLUTTERING, PALPITATIONS, HEADACHES, WEAKNESS, SHORTNESS OF BREATH, COUGH, LOWER ABDOMINAL PAIN, MUSCLE PAIN, CHEST PAIN. PAIN AND SWELLING AT INJECTION SITE.
Migraine; Headache; This is a spontaneous report from a contactable consumer (patient) received from a female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medication history and concomitant medication were not reported. After receiving the first dose of bnt162b2, the patient experienced migraine and headache. The patient would like to delay getting the second dose instead of getting it on 10Mar2021 and she would like to get it on 12Mar2021. The outcome of migraine and headache was unknown.  No follow-up attempts are required; information about lot/batch number cannot be obtained.No further information is expected.
Telephone 3/16/2021 COVID Vaccine Clinic  APRN Family Medicine Other  Reason for call Conversation: Other (Newest Message First) APRN      3/16/21 4:48 PM Note    This provider from the Covid-19 vaccine clinic called pt to follow up on her recent covid-19 vaccine that was done on 03/01/2021.  She has end stage COPD and noted that she became more short of breath 1-2 days after receiving her 2nd dose on 3/2/21.  She tried to manage it on her own at home, but noted in the couple of weeks that it was not improving. She would be more short of breath with and w/o ambulation. Her husband, took her to an express care place today (03/16/21) whom evaluated her with blood work, chest x-ray and gave her a breathing tx.  States she was prescribed abx and prednisone.  She does not see much change yet since discharge.  On her discharge paperwork, she notes that she was instructed to let  vaccine clinic and pcp know about her potential reaction vs. Exacerbation of copd.  Pt states she is scheduled to see her pcp on Monday, 3/22, along with her pallative care team.  She also is scheduled to see her heart doctor on Friday the 26th.   We discussed reasons to return to express care and/or ED. Otherwise she's to keep her appt with providers as mentioned above.  Denies any further questions or concerns.   Pt is appreciative of phone call.    Email sent to RN for agency reporting  ARNP
Pt is 9 mths old. Got Hep B # 3, IPV # 3, and Prevnar #3 on 10/29/2002 at 3pm. Pt slept from 3pm to 8pm, woke up screaming and remained fussy till 1:30 am 10/30/2002. Pt refused to drink, eat, lethargic, and had temp. 103.8 till 10/30/2002  10am.
This literature marketed report has been received from authors of a published article, referring to a female child with ataxia telangiectasia and lymphopenia. On an unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. The previously healthy patient was initially evaluated at the age of 15 months for recurrent dizziness and poor balance. Between the ages of 15 and 22 months, her neurologic symptoms worsened. Extensive imaging revealed no abnormalities. An ear, nose, and throat (ENT) evaluation was undertaken secondary to persistent middle ear effusions. Around the age of 22 months a Pediatric Neurologist finally determined that her symptoms represented ataxia and not developmental delay. Evaluation at that point included measurement of alfa fetoprotein levels which were markedly abnormal. After referral to our center, an immunologic evaluation revealed abnormal quantitative immunoglobulins, marked lymphopenia and absent response to polysaccharide antigens when challenged with the pneumococcal polysaccharide vaccine (no therapeutic response). Genetic testing confirmed the suspected diagnosis of Ataxia Telangiectasia and revealed the presence of two novel mutations in the Ataxia-Telangiesctasia mutated (ATM) gene that had not been previously reported. The outcome of the event was unknown. The authors considered the event to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience.
Vomiting approximately 16 hrs and 20hrs after vaccine. Urticaria approximatley 20hrs. after vaccine - feet, face, arms, trunk.
This spontaneous report was received from a pharmacist concerning a 63 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-DEC-2016 at 10:43, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously in the left arm, lot # M033335, expiration date 11-OCT-2017, for prophylaxis (dose number were unknown), which was improperly stored at 8.96 degrees Fahrenheit for 2 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. The pharmacist stated that their freezer temporarily read the temperature out of range because 2 non-frozen cold packs were placed both above and below sensor, once removed the temperature stabilized and returned to normal. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received.; Sender's Comments:  US-009507513-1612USA004193:
Vaccine administered after stored greater than thirty days in refrigerated temperatures. A case opened with the vaccine manufacturer demonstrated the vaccines were still safe and effective but requested that we report it.
died since taking your covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "died since taking your covid vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Added: Reporter also reported that he/she has countless sick friends thanks to it. Stated that the clock was ticking, the truth will prevail.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020087 same reporter/drug/event, different patient;; Reported Cause(s) of Death: died since taking your covid vaccine
Complaints of dizziness after administration of vaccine for aproximately 20 minutes. Patient states he has not had anything to eat or drink yet this morning aside from redbull prior to administration of vaccine. Symptoms resolved at 11:58 and patient left site.  Educated that if symptoms return to seek care at an emergency room.
pt recv vax 20OCT97 & 3 days later, pt exp inj site rxn described as redness @ the site;
Onset blotchy, warm sensation to neck on 09/30 then outbreak w/hives on 10/1/07 located on (L) arm, shoulder, along waistband arms hips on back, right thigh.
Systemic: Other- patient needed to have Epinephrine administered after lunch due to asphyxiation possibly due to napkin stuck in throat.  Approximately one hour after receiving covid 19 shot that moring-Severe
This spontaneous report was received from a nurse practitioner and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In September 2017, the patient was vaccinated the first dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). In November 2017, the patient was vaccinated with the second dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). In January 2018, the patient was vaccinated with the third dose of GARDASIL 9, intramuscularly, lot# N015089 and expiration date: 20-OCT-2019 (dose was not reported). There was no adverse effect reported.
Tested positive for COVID-19 on 20Jun22; Tested positive for COVID-19 on 20Jun22; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 as dose1, single (Lot number: EL3257), in right arm, on 15Mar2021 at 09:00 as dose 2, single (Lot number: EN6203), in right arm and on 30Nov2021 at 09:00 as dose 3 (booster), single (Lot number: FJ1620) at the age of 37 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "birth control" (unspecified if ongoing). Concomitant medication(s) included: ENPRESSE taken for contraception. Past drug history included: Augmentin, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant) with onset 19Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 19Jun2022, outcome "not recovered" and all described as "Tested positive for COVID-19 on 20Jun22". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  Clinical course: No other vaccine was taken in four weeks. Facility type vaccine was Walkup site  No follow-up attempts are possible. No further information is expected.