chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired Daptacel was administered to patient/No AE; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 years old female patient who received expired dose of vaccines DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included POLIO VACCINE INACT (IPV), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 15-Nov-2019, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot C5307AA Expiry Date: 23-OCT-2019] via unknown route in the left arm.  It was a case of actual medication error due to expired vaccine was administered to patient   At the time of report no adverse event was reported.  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 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.
Patient was given Hep A adult vaccine instead of Hep A pediatric vaccine. Patient had no reactions to the vaccine. Patient's mother was informed that patient may have additional pain at injection site and to monitor adverse reactions.
Since first day of adverse events:   Injection site is hot to the touch, even through a shirt or other piece of clothing; Golf-ball sized lump under skin at injection sight; injection site is visibly red and bruised; aches and pains in both shoulders and neck; consistent headache; fatigue
Husband called on 7/12 to report chickenpox-like (itchy red blisters that scab over) cutaneous skin reaction with localized mostly to her abdomen and back. Reaction still ongoing, onset noticed by patient a few days after vaccine administration. Patient using calamine lotion to help with itchiness, and pharmacist also suggested using antihistamines like Benadryl to alleviate symptoms. Asked to follow up with primary care provider for actual evaluation, and treatment if necessary.
Patient developed projectile vomiting and grossly bloody stool 1 day after receiving rotavirus vaccine. She was found to have ileocolic intussusception which was reduced w/barium enema.
expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that flu-like symptoms after receiving the vaccination. No concomitant medications were provided. No treatment medications were provided.
Client became dizzy and fainted in monitoring area after vaccination.  Vital signs 80/54, 85, 14. EMS dispatched to site however patient fully recovered and declined going to ER for evaluation.
an hour after shot, I began to feel drained. Layed down for rest of day, the following day I was exhausted able to move about in for short periods.  The third day I was asleep on and off most the day. The fourth day I felt a  little better and did some work (I work from home) by the fifth day I felt much better had normal energy.
Narrative:  83yo male patient died on 1/8/2022 at home in home hospice care. with the following: Medical Hx: Alzheimer's dementia, vascular dementia, moderate valvular aortic stenosis, HTN, HLD, BPH, iron deficiency anemia, peripheral vascular disease, esophagitis, Rectal cancer s/p Lower Ant. Resection (2003) and ileostomy closure (2004), LUL carcinoma s/p wedges 2007 then lobectomy 2009. Surgical Hx: Lower Ant. Resection 2003, ileostomy closure 2004, Fem-Fem bypass 2006, LUL VATS Wedge 2007 and LUL Lobectomy 2009, OU IOLs 2021 Pt had received covid vaccines at non facility site on 7/14/21 & 8/13/21. This pt's death appears to not be related to covid vaccines given pt's advanced age, comorbidies, and long length of time between death & date of vaccine administrations.
Pt recvd MMR vax on 6NOV91 & approx 2 1/2 hrs following va pt exp a grand mal sz; pt was hospitalized & a neuro exam & CT Scan were nl; EEG was abn;
Tiredness, fever (101.2), chills, muscle pains, headach, feeling unwell
Client verbalized feeling dizzy and nauseous  about 5 minutes after vaccine administration. Client appeared pale, and sweaty.  Client was laid down on vaccine exam table with knees bent. Routine vitals were taken every few minutes which remained mostly stable - pulse slightly elevated. Client was given some water to drink. Client began to have more visible color in face about 30 minutes afterward. Client verbalized feeling better after about 35-40 minutes after vaccination.
PATIENT FELT LIGHTHEADED AND DIZZY ALMOST IMMEDIATELY AFTER RECEIVING VACCINE
3 days after the flu shot vaccine my blood pressure was much higher than it usually is(bp taken at rest 130/70 on this instance).   I could feel my heart beating even while sitting down and resting. Symptoms lasted for aprox. 24 hrs.  E-mailed my primary NP for advice regarding high bp (did not mention flu vaccine); no action taken.
This spontaneous report was received from a physician via company representative referring to a 85 year old female patient who on 28-AUG-2013, was vaccinated with a dose of PNEUMOVAX23 (lot # not reported), intramuscular. Concomitant therapies included an unspecified flu vaccine. The physician reported that on 28-AUG-2013 the patient had an injection site reaction to PNEUMOVAX23. The PNEUMOVAX23 was administered concomitantly with an unspecified flu vaccine, but these vaccines were administered in separate arms. Other concomitant medication information for this patient was not specified. The injection-site reaction was described as red and hot when the patient spoke to the physician. The outcome of injection site redness and injection site hotness was unknown. This is one of two reports from  the same reporter source. Additional information has been requested.
Blurred vision, zig-zag patterns, temporary vision loss, and sensitivity to light in left eye for about 20 minutes.
Bump/ hive at varicella injection site size of a penny with redness around it.
brain fog; slept for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of hypersomnia in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced hypersomnia and foggy feeling in head. On an unknown date, the outcome of the hypersomnia and foggy feeling in head were recovered/resolved.   It was unknown if the reporter considered the hypersomnia and foggy feeling in head to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received 2nd shingles shot along with his/her booster (unspecified vaccine) shot and slept for 3 days with brain fog. The patient was back to normal now. The patient never want shingles ever, ever again. It was unknown if the reporter considered the hypersomnia and foggy feeling in head to be related to booster (unspecified vaccine) shot. Additional supportive information: The follow-up would not possible as no contact details were available.
Pt received Flu Vaccine on 10/8/2019. C/O area becoming infected. Treated in the ED.
Positive covid test 4/2/21. Headache, sinus congestion, body aches, store throat
Client c/o lightheadedness 15 minutes after vaccination, was observed and VS monitored and were found to be stable Discharged home at 12:20p.m.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Mild, Systemic: Hyperventilation-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Mild
Saturday March 13 Evening . Stroke symptoms, facial drooping, weakness in legs, difficulty walking, speech difficulty, loss of use of left arm, rash on hands. TPA administered. Situation resolved. Hospitalized 4 days.   Note: My brother who resides in a different state suffered a stroke March 12.  He also received the Pfizer vaccine date unknown.
got a very metallic taste in my mouth; sleep a lot; tired; This is a spontaneous report from a contactable healthcare professional.  A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140/ELO140), via an unspecified route of administration, at the left arm on 30Dec2020 06:30 at a single dose for COVID-19 immunization at a hospital.  Medical history included seasonal allergies and doesn't take medications. On the same day of 30Dec2020, about an hour after vaccination, patient got a very metallic taste in mouth, which lasted for about 12-18 hours and did sleep a lot, which she expected, but woke up about 11 at night and still had it and it was gone. Patient knew she slept longer than she normally does, went to bed at 1PM and slept until 11PM, which is not usually normal. Was up for about an hour or two and then went back to bed until 8AM of 31Dec2020. Patient was concern was if it was some type of reaction that it would mean she was going to have a stronger reaction to the second one and stated it was irritating but not a huge deal. Patient also felt tired and expected it as she worked five 12-hour shifts in a row. Patient was not sure if the metallic taste was connected to the COVID-19 vaccine. No prior vaccinations within 4 weeks. Outcome of the events was unknown.
Swollen arm at site of injection. Pt reports onset 24 hours after vaccine, had fever and chills beginning >24 hours after vaccine, for 3 days afterward. Pt did nor seek medical attention.
Initial misuse case was received from a healthcare professional on 16 OCT 2013. Cases were received on 21 March 2014. A patient whose demographic details, medical history and concomitant medication were not reported received a dose of FLUZONE ID on an unspecified date (route, site, dose and batch number not reported). It was reported that on an unspecified date patient received vaccine in inappropriate age. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: None.
Coughing followed by gagging and vomiting. Then quit breathing. One hour later another episode of coughing and quit breathing again.
Called to obs area due to patient passing out. He is passenger in the car due to history of similar episodes of syncope with giving blood, getting shots in the past. Wife states that he was out from time it took to drive from injection area to obs area (less than 20 seconds). He is coherent, AOx4, RRR, CTAB on exam. He states that he does feel back to normal at time of my exam/questioning.  BP 113/84, pulse 68, oxygen saturation 100% on room air. Extended observation time by 15 minutes, no further issues and patient left under wife's care.
Around 5-6pm patient started to get hot, sweaty, and throat started to swell up.   Patient was sweating through dinner and did not feel good at all.  Later, started to feel cold so took shower and Tylenol. On Sunday, symptoms worsen and started alternating Tylenol and Ibuprofen alternating; had diarrhea after hot/cold flashes.  On Monday patient rested, symptoms continued, and coughing started. Yesterday patient felt better but still was sweating profusely.  Patient has overall body aches and hot/cold flashes.  Patient could not get in touch in PCP so yesterday went to ER.    Patient tested for Flu A/B and strepresults were negative. Doctor specified symptoms were probably related to the vaccine.  Patient given Afrin, Tylenol, Ibuprofen, Mucinex D, throat lozenges.  Patient noted her children received the vaccine the same day with no problems. Patient feels a little better today.    Patient has only received Flu vaccine the last 7 years; has not experienced any problems.
ITCHY THROAT; SORE THROAT; CONGESTION; This spontaneous report received from a patient concerned a female of unspecified age (ethnic origin unknown).  The patient's height, and weight were not reported.  The patient's concurrent conditions included allergies (further details not provided). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number unspecified) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the patient experienced itchy throat, sore throat, and congestion (event captured as nasal congestion). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itchy throat, sore throat and congestion was not reported. This report was non-serious.
nothing until 1 hour later, then increasing arm soreness and stiffness, fatigue and slight nausea.  By nightfall pain in arm severe,  Took 2 ibuprofen and felt better and was able to go to sleep.  Still sore in morning, trouble pulling clothes over head, but definitely better.
Ever since the first vaccine I feel like my immune system is a lot weaker then what it used to be. I am noticing I am getting sick more frequently now then before my first and second vaccine and I am not exactly sure why. I have always been a healthy person. I did contract Covid AFTER the vaccines.
Severe loud tinnitus in my ears. It's a very loud ringing, hissing, squeaking continuous noise. It interferes with my sleep and quality of life. It's very annoying!
Muscle fatigue lasting 2 weeks. Muscles easily cramped, strained and pulled.  Excessive sweating on whole body which is on-going.
pt recv vax; broke out w/ chicken pox 6 days p/ vax was given; no hx of exposure;
her face was swelling/still swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (her face was swelling/still swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced SWELLING FACE (her face was swelling/still swollen). At the time of the report, SWELLING FACE (her face was swelling/still swollen) had not resolved.            Action taken with mRNA-1273 in response to the events was not Applicable.
Pt recvd 2nd dose of vax on 3APR92 & day p/vax c/o stiffness in joints; w/in 10 days devel severe arthralgia assoc myalgias; lab eval was pos for rheumatoid factor, c-reactive protein & dec red blood cell magnesium;
N/V, HA, Fever, Fatigue, CP, SOB, Confusion
This spontaneous report as received from a physician refers to a 51 year old patient. On 27-MAR-2013 the patient was vaccinated with VARIVAX (Merck) (lot # not reported) 0.5 ml, once, subcutaneous. No other co suspect were reported. No concomitant therapy was reported. The physician reported that on 13-APR-2013, the patient developed an unspecified rash. The physician requested to complete a PCR analysis for rash that patient developed. The patient sought medical attention at office visit. The outcome of the patient received VARIVAX (Merck) and developed an unspecified rash was unknown. Additional information is not expected.
Slight local erythema at injection and arthralgia of left elbow. Treatment: cool compresses.
Patient reports having flu-like symptoms of fever and chills resolving 12/4, patient woke on 12/5 feeling weak and then experienced syncopal event with little warning. Patient reports feeling a little weak but otherwise is recovered,
Since the first three vaccine ,I had hand surgery and severe arthritis developed in my hand and fingers. Then I took my 4 th vaccine on 7/14/2022 after having the surgery on my second hand and have also developed severe arthritis in the second hand andfingers
Still having nausea and chills; Still having nausea and chills; This is a spontaneous report from a contactable consumer. This 73-year-old male consumer (patient) reported for himself that:  If known, what role does the reporter have? Patient/Consumer Patient Details: Gender: Male  Pfizer Product Name or Description: 2nd shot Covid-19 vaccine 01Mar2021 Also takes testosterone shots  Was the product used by the patient? Yes  Description of the event, comment, or concern as provided by the reporter: Still having nausea and chills  Follow-up attempts are needed. Information about batch/lot has been requested. .
difficulty passing urine; Back pain; Fatigue; Body ache; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (difficulty passing urine), BACK PAIN (Back pain), FATIGUE (Fatigue), MYALGIA (Body ache) and PYREXIA (Fever) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced FATIGUE (Fatigue), MYALGIA (Body ache), PYREXIA (Fever) and HEADACHE (Headache). On 21-Feb-2021, the patient experienced DYSURIA (difficulty passing urine) and BACK PAIN (Back pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, DYSURIA (difficulty passing urine), BACK PAIN (Back pain), FATIGUE (Fatigue), MYALGIA (Body ache), PYREXIA (Fever) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.
A couple days after shot, symptoms of psychosis began.  Talking to someone that I thought was there but  wasn't actually there, Full on conversations, was unable to sleep that night due to this.  Hallucinations of people being there when they were not.  Memory Loss, dysnomia, inability to recall events as they truly happened. Believing conversations were real when they never truly happened.  Extreme agitation, irritability, violence, inability to focus, extreme impulsivity and almost manic behavior, racing thoughts, increased blood pressure. It is now 3 months since I have had the first dose, I do not feel my normal self and I believe the vaccination triggered the psychosis.
On 6/20/00, the pt woke up with redness and itching. The symptoms then progressed into swelling to large sized approximately 60 x 70 mm. No systemic reactions.
itching; she received the 1st dose of Shingrix in April 2018, a late 2nd dose in November 2019; Extra dose administered; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in April 2018).   In November 2019, the patient received the 2nd dose of Shingrix. In March 2020, the patient received the 3rd dose of Shingrix. In March 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced extra dose administered. In November 2019, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced pruritus. On an unknown date, the outcome of the pruritus, drug dose administration interval too long and extra dose administered were unknown.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were received as follows: The patient received late 2nd dose in November 2019, which led to  lengthening of vaccination schedule and an extra 3rd dose in March 2020, which led to extra dose administered.  One week after receiving the 3rd dose, she developed itching all over her body; no rash.  The itching is ongoing at the time of report. The reporter consented to follow up.
Rash on arm/ Back; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number N9CA2, expiry date 2nd July 2021) for prophylaxis.   On 17th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and has rash on chest, arms and back.  The reporter gathered patient information.
This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot #, expiration date, albumin status, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion for 72.68 degrees Fahrenheit for 84 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as no consent was given for further contact.
pt recv vax 15OCT96 & 6PM on 17OCT96 pt fainted;upon arousal pt c.o stomach pain, diarrhea, & nausea;pt dies in home 8:45Pm;
Sore chest; Stiff neck; Sore arm / shoulder; This spontaneous case was reported by a pharmacist and describes the occurrence of CHEST PAIN (Sore chest), MUSCULOSKELETAL STIFFNESS (Stiff neck) and PAIN IN EXTREMITY (Sore arm / shoulder) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMITRIPTYLINE for an unknown indication.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Sore chest), MUSCULOSKELETAL STIFFNESS (Stiff neck) and PAIN IN EXTREMITY (Sore arm / shoulder). At the time of the report, CHEST PAIN (Sore chest), MUSCULOSKELETAL STIFFNESS (Stiff neck) and PAIN IN EXTREMITY (Sore arm / shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Patient became so dizzy he could not stand up.  Said he felt rubbery, like syncope was eminent.