chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SHORTNESS OF BREATH - DIFFICULTY BREATHING AND TALKING AT SAME TIME- DRY COUGH- COULDNT TAKE DEEP BREATH IN. WENT TO EMERGENCY ROOM AND ADMITTED TO HOSPITAL FOR 3 DAYS. PNEUMONITIS DIAGOSIS- GROUND GLASS OPACITIES IDENTIFED  IN LUNGS .  MYOCARDITIS, AND/OR CARDIOMYOPATHY.
12/30/21 @2130, patient experienced chest pain, centralized that radiated to the neck bilaterally, he then went to sleep. Had another episode with SOB and went to ER 12/31/21, Covid-19 positive incidentally- no s/s. Patient admitted.
got shot first day and felt fine - woke up and had liver pain - abdominal discomfort - low grade head ache - blood pressure fine - blood sugar was normal stoole was normal
Information has been received from a physician concerning a 19 year old female patient who in 2008, was vaccinated with her first and only dose of GARDASIL (lot # not reported), intramuscularly. The physician reported that on 21-AUG-2008, the patient had developed Guillain-Barre Syndrome after receiving vaccination with GARDASIL vaccine and was hospitalized in a hospital. On an unknown date, the patient was released from the hospital after she recovered. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Headache, Sedation, Rash, Extreme fatigue, hives Narrative:
This case was reported by a consumer via call center representative and described the occurrence of lower extremities weakness of in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced lower extremities weakness of, joint disorder, pain in arm, mobility decreased and walking difficulty. On an unknown date, the outcome of the lower extremities weakness of, joint disorder, pain in arm, mobility decreased and walking difficulty were unknown. It was unknown if the reporter considered the lower extremities weakness of, joint disorder, pain in arm, mobility decreased and walking difficulty to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient reported extreme weakness in legs, joints and left arm. The patient's left arm was also so painful and weak at times she could not use it. The patient had trouble driving or even lifting the arm up to her face. The patient walked regularly and had never had any muscle or joint problems before taking this vaccine, now it was a struggle to walk to the bathroom when she get out of bed or after sitting for a bit. The patient stated that something was wrong with this vaccine.
got shingles the worst case ever / Suspected vaccination failure; blind in the left eye; got shingles the worst case ever; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got shingles the worst case ever / Suspected vaccination failure) (serious criteria GSK medically significant), blind left eye (Verbatim: blind in the left eye) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles the worst case ever). The outcome of the vaccination failure was unknown and the outcome of the blind left eye and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, blind left eye and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, blind left eye and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JUN-2023 This case was reported by a patient's child via interactive digital media. The patient received the Shingles shot then got shingles the worst case ever. The patient went blind in the left eye. The reporter mentioned that there was a medication that lessens symptoms if anyone got Shingles. The reporter suggested that it was needed to look up safety and effectiveness of this shot and all vaccines. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Dizziness; This is a spontaneous report received from a contactable consumer, the patient. A 68-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6201) in the left arm on 23Feb2021 at 13:15 (at the age of 68-years-old) and second dose (Lot/batch no: EN6208) in the left arm on 16Mar2021 at 13:15 as a single dose via unspecified route of administration for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included Amlodipine/Benazepril (10-20mg) and Carvedilol (6.25, units unspecified) for an unknown indication from an unknown date to unknown date. The patient previously took Amoxicillin and experienced drug allergy on an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Mar2021, the patient experienced dizziness, when getting up, laying down and bending over. The patient did not receive treatment for the event. The clinical outcome of the dizziness was not recovered. No follow-up attempts are needed. No further information is expected.
blood vessels are not reacting properly; Swollen lymph nodes; Legs keep swelling; Oozing fluid out of legs; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 83-years-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 01Apr2021 at the age of 83-years-old (Batch/Lot Number: ER8732) as single dose for COVID-19 immunization. Medical history included hip arthroplasty from Jan2021 to an unknown date.Provide other relevant medical history including but not limited to these conditions were diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine. Patient took first dose of BNT162B2(COMIRNATY, Solution for injection, Batch/Lot number was EN6206) on 11Mar2021for COVID-19 immunization. Family Medical History Relevant to AE was not reported .The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On Unspecified May2021, (these symptoms began about 3 weeks ago) between 1pm to 2pm after vaccination the patient experienced swollen lymph nodes, legs keep swelling, oozing fluid out of legs, on an unspecified date blood vessel are not reacting properly. The patient underwent lab tests and procedures which included blood potassium: normal on May2021, blood test: normal on May2021.Therapeutic measures were taken as a result of swollen lymph nodes, legs keep swelling, oozing fluid out of legs treatment included "10 water pills."which have all been taken, last water pill was on 18May2021. Other Conditions includes still recovering states that she had a messed up physical therapist. The outcome of events swollen lymph nodes, Legs keep swelling was not recovered, oozing fluid out of legs was recovered on 21May2021, blood vessels are not reacting properly was unknown.  Information on lot/batch number was available. Additional information has been requested.
pale, prolonged sleep w/difficulty arousing pt, dec responsiveness to environmental stimuli approx 8 hrs; no treatment;
This spontaneous report was received from a physician who is a 67-year-old female patient. Current conditions included chronic sinusitis and history of endometrial cancer. On 24-SEP-2013 the patient was vaccinated with a dose of 0.5 milliliter (ml) PNEUMOVAX23 (lot#, expiration date not reported) intramuscularly in the right arm. Concomitant therapies included FLUVIRIN administered on the same date in the left arm. The physician reported that she developed redness and pain at the injection site on 25-SEP-2013. The patient also developed right ear pain and nasal congestion. On 27-SEP-2013, the physician experienced a warm sensation at the nape of her neck after walking for exercise. The sensation resolved after she drank sugar water. Later that evening, she developed welts on the right and left scapula area, which resolved with the use of BENADRYL and unspecified cortisone cream topically. On 30-SEP-2013, the patient developed a circular welt on her mid-back. On 01-OCT-2013, she developed welts under both axilla. These welts also responded to BENADRYL and cortisone cream. The evening of 02-OCT-2013, the patient developed a large welt on her left forearm which she treated with BENADRYL and topical cortisone cream. The physician stated she was evaluated on 03-OCT-2013 by her unspecified healthcare provider who diagnosed an unspecified allergic reaction. It was suggested that the patient eliminated medications and foods one at a time in an attempt to determine the cause of her allergic reaction. Laboratory diagnostic studies were not performed for the events. The patient sought medical attention for the events (office visit). The events were resolving at the time of this report. Causality was not reported. This is one of the reports from the same reporter. Additional information is not expected.
This spontaneous report has been received from a licensed practical nurse referring to a patient of unknown age and gender. No current of historical conditions were reported. On 17-MAY-2016 the patient was vaccinated with PEDVAXHIB (lot # L051122, expired date of 12-OCT-2018, dose and route unknown). The vaccines were improperly stored under 9.1 Celsius degree for 30 minutes. No previous temperature excursion. Data logger was involved. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Physician ordered FLUMIST (intranasal seasonal flu vaccine) to be administered on 12/29/09. H1N1 mist erroneously given instead. Patient previously received H1N1 injectable 0.25 mL IM doses on 11/2/09 and 12/8/09, so pt received 3 doses of H1N1 vax in total. Child with no known sequelae of 3rd vaccine.
undiluted vial of Pfizer vaccine was given to patine patine could have received upto 180mcg instead of 30mcg dose
7 month old given an adult (1mL) dose; 7 month old given an adult (1mL) dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 7-month-old female patient who received HBV (Engerix B adult) (batch number AC397, expiry date 8th August 2023) for prophylaxis.   Previously administered products included Engerix B (1st and 2nd dose received on an unknown date).   On 22nd October 2021, the patient received the 3rd dose of Engerix B adult 1 ml. On 22nd October 2021, unknown after receiving Engerix B adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional details were provided as follows: The nurse reported that the 7 month old patient received an adult (1mL) dose of Engerix, which led to overdose and adult product administered to child. No symptoms were reported. The reporter consented to follow up.
Moderna Covid-19 Vaccine EUA Itching and redness around injection site 8 days following injection
Caught the flu; Nasal congestion; Sore throat; Coughing; This spontaneous case was received on 04-Nov-2022 from other non-healthcare professional (consumer) via Agency (reference number: SEQW22-05445) and concerned a 63-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications. The patient described herself as healthy and added she was not immunocompromised in any way.  On 17-Oct-2022, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v dose: 0.5 ml, route of administration and anatomical location: not reported) for active immunization against influenza disease caused by influenza virus subtypes A and B present in the vaccine. The batch number was not reported.  On an unspecified date in 2022, an unknown amount of time after receiving Afluria Quadrivalent, the patient claimed to have caught the flu. The patient stated her husband and a neighbour (reported as 'neighbor') had it and that she must have caught it from them. The patient reported sore throat, coughing and nasal congestion and knew for a fact that was it not Covid 19 considering her test came out negative.  The outcome of the events was not reported.   The reporter did not provide causality assessment.  The event of 'flu' was considered to be medically significant by Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 63-year-old, female patient was vaccinated with Afluria Quadrivalent. An unknown amount of time following vaccination, the patient caught the flu. Reportedly the patient developed sore throat, coughing and nasal congestion. As reported, Covid 19 test came out negative. The patient had no relevant medical history and was not taking any concomitant medications. Information regarding the additional diagnostic findings was not provided. Causal role of the suspect vaccine is unassessable, with the currently available information and unclear temporal relationship.; Sender's Comments: A 63-year-old, female patient was vaccinated with Afluria Quadrivalent. An unknown amount of time following vaccination, the patient caught the flu. Reportedly the patient developed sore throat, coughing and nasal congestion. As reported, Covid 19 test came out negative. The patient had no relevant medical history and was not taking any concomitant medications. Information regarding the additional diagnostic findings was not provided. Causal role of the suspect vaccine is unassessable, with the currently available information and unclear temporal relationship.
Patient was given an extra dose of Prevnar. In the chart, it showed that the patient had only received 3 doses of Prevnar, but 2 were after the age of 1 so therefore the patient did not need the fourth one that was given on 9/14/22. Provider spoke with parent and patient is doing well.
Reported 30-40 min after vaccine administration in respiratory distress, airway difficulty crowing. Epinephrine 0.3cc given sq O2 at 4 liters. IV solumedrol and IV Benadryl 50mg given improvement of breathing some continued cough when transported on O2 to medical center.
MODERNA COVID VACCINE #3 GIVEN 5/28/22, LOT #058A22-2A; pt admitted to hospital with worsening SOB; hypoxia; c/o diarrhea and generalized weakness; 1 wk ago pt dx with COVID, started on Paxlovid, completed the course; diarrhea has continued; placed in ICU; required vasopressors, ABX, steroids, BiPAP; didn't respond to tx in ICU; pt found passed away in the hospital
Arm pain and redness began the day after administration and continued to worsen. On 9/1 when reported the patient said her redness spread and she began getting pink dots on her face.
Day 1-Confusion and weakness Day2-Increase in weakness, inability to swallow, confusion, fatigue Day 3-Weakness, confusion, incontinence, hospitalized for hypoxia, pneumonia Day 20- Deceased
We were informed that the vaccine that the patient received may have been stored prior to administration under conditions that departed from the manufacturer's specifications.
Numbness and tingling - pain - weakness in legs and arms starting app. 12-1-12. Extensive blood tests, nerve conduction study, spinal taps. Treatment consist of pain meds and physical therapy.
Bruising for 2 weeks after shot at injection site. Petechiae on legs and bruising on legs. Pain in joints and muscles. Extreme Fatigue. Sleepiness. Headaches. Nausea. Confusion.
Patient reported swelling about the size of her palm ~3in in diameter in the first 4 hours after receiving vaccine.  Called the pharmacy and was instructed to use ice to reduce swelling and NSAIDs or APAP for discomfort.     Patient came to the pharmacy 24 hours later and the swelling had increased to ~6 in diameter below the injection site, was warm to the touch and tender.  Patient did not use ice and slept on the affected arm the evening before.  Patient referred to PCP or urgent care to assess reaction.   They drew around swelling and will watch and wait and follow up in 2 days as long as the swelling does not increase.  Patient was recommended to use Tylenol and ice in meantime.
PATIENT PREVIOUSLY RECIEVED 1 DOSE OF PFIZER VACCINE (1/11/2021-LOT EL1625)
She had headache; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (She had headache), CHILLS (chills) and NAUSEA (nausea) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced HEADACHE (She had headache), CHILLS (chills) and NAUSEA (nausea). On 24-Feb-2021, HEADACHE (She had headache), CHILLS (chills) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information included meclizine ( The patient did not specify for which dose event the patient had taken the drug).   This case was linked to MOD-2021-065280 (Patient Link).
Patient received an adult dose of Pfizer instead of a pediatric dose. Mother had input her sons birthday instead of a her daughters and based off the sons date of birth, the daughter was eligible. Upon giving the vaccine, the mother noticed the wrong date of birth but it was too late. Spoke with patients  mother and advised her that her daugher received the adult pfizer dose. Second dose is scheduled on Feburary 16th and we've amde arrangements to provide the pediatric dose to the patient on that date. Pharmacy manger will be following up with the patient daily to monitor for side effects
has always has strong side effects, like 2 or 3 days; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (has always has strong side effects, like 2 or 3 days) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (has always has strong side effects, like 2 or 3 days). At the time of the report, IMMUNISATION REACTION (has always has strong side effects, like 2 or 3 days) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   Treatment medication not reported.  The patient stated, she got all the Moderna shots and boosters and has always has strong side effects, like 2 or 3 days. Her husband took all Pfizer and never gets side effects.   This case was linked to US-MODERNATX, INC.-MOD-2023-743874 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743874:Same patient monovalent moderna vaccine
About eight hours after my vaccine, I began to have chills, fever, headache, pain/tightness in my calves. Later that night I felt hot, sweaty, intense pain at injection site, headache become worse. The next morning I had body aches, skin felt tender to touch, headache, pain in ribs, ear ache, lethargy, continued pain in calves and injection site.
Initial misuse report received from health care professional on 13 May 2014. IPOL, TENIVAC, FLUZONE and MENACTRA were stored at inappropriate temperature as the fridge temperature had dropped at 32 Fahrenheit. No adverse event was reported. List of documents held by sender: none.
My tongue started tingling and got a bit swollen about noon on 1/28/2021.  The swelling in my tongue did not go away and persists . I originally thought it was angioedema but when the swelling did not go down I did not know what the problem was! I heard last night about COVID tongue and knew that is what I was/am dealing with.  For what it?s worth I thought I?d let you know.  I tried to let Vsafe know but did something incorrectly and my message didn?t go through.
Area around injection site slightly warm/ and pink 3d post injection. C/O tenderness shoulder to elbow had - titer so vaccine given. States had fever at home prior to reporting 101.5 - 103 per his account. He went to MD 8/13/07 and was given Rx for antibiotic.
Pt had nausea and vomiting for several days (April 1 and 2, 2003). Began experiencing leg weakness on 4/2/03. On 4/4/03 she was unable to stand and walk. Admitted to hospital; diagnosed with Guillain Barre syndrome. Received plasmepheresis treatments. Started on rehabilitative therapy.
Patient was given a 4th dose of covid vaccine (Moderna). The medical assistant saw that in patient's chart there were only 2 doses of covid vaccine administered.  English is not the patient's first language and she was offered an interpreter, but refused interpreter.  MA offered if she would like a booster dose, which the patient said yes to. However, because of the language barrier, the patient may have misunderstood and thought MA was asking if she had the booster yet and answered yes to that. MA did ask twice to ensure that was what patient wanted. Covid card was shown to MA where only 2 dated labels were visible.  MA gave covid injection with the flu vaccine and it wasn't until after the injections were complete, patient realized that she had gotten a covid vaccine. The patient then showed the covid vaccination card again and saw that the 3rd dose was documented on the back of the card. Patient was frustrated and worried about her health. A nurse sat down with the patient to go over side effects and answered patient's questions. Message was sent to patient's PCP for review. Another Nurse called and spoke with patient's daughter to see how patient was doing and if there are any side effects. Daughter had stated patient was at work and feeling well. Questions and concerns were answered by nurse. No adverse reactions reported by patient or daughter.
12/10/21  Pt states since last weekend (Sat/Sun) she has been having congestion, post-nasal drip and a cough. She reports a mildly productive cough of green/yellow sputum.  She has been taking a decongestant at home and it has been helping.  She denies fever but endorses subjective chills.  Husband also has a cough.  Is concerned that 2 years ago this happened and lasted for about 3 months before it resolved, finally improved with DuoNeb.  Is vaccinated x2 for Covid, no flu shot.  Constitutional: Positive for chills. Negative for fatigue and fever.  HENT: Positive for congestion, postnasal drip, rhinorrhea and sneezing. Negative for ear pain, facial swelling, hearing loss, sinus pressure, sinus pain, sore throat,