chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a health professional via a medical science liaison, described the occurrence of shingles in a 45-year-old female patient with systemic lupus erythematosus. In 2013 the patient was vaccinated with a dose of VARIVAX (Merck). Other suspect therapies included BENLYSTA. Concomitant therapies included prednisone (manufacturer unknown), PLAQUENIL and methotrexate (manufacturer unknown). The patient received her first infusion of BENLYSTA (Variable dose) for systemic lupus erythematosus in July 2013. She received her second infusion of BENLYSTA as scheduled 2 weeks later (date was unknown) and 48 hours later in July 2013 she had a shingles outbreak. The outbreak was treated with antiviral medication and resolved (date was unknown). One month after, in August 2013, the outbreak resolved she received the VARIVAX (Merck) (lot#, dose, frequency were unspecified). Six weeks after she received the vaccine she had her third infusion of BENLYSTA. Within 24 to 36 hours she had another shingles outbreak. The outbreak was treated again and resolved. She experienced shingles after 4-5 infusions total. She received the VARIVAX (Merck) after only the first outbreak of shingles. Every time the outbreak was treated and resolved before trying the next infusion. After a total of 5-6 infusions of BENLYSTA (there was no shingles after the first infusion) the decision was made to discontinue her from BENLYSTA. The shingles that occurred after her last infusion of BENLYSTA was still in the process of resolving, but it had improved. The patient never made it out of the loading phase for BENLYSTA because they would have to wait for her shingles to resolve before another dose was administered. Treatment with BENLYSTA was discontinued on an unknown date. The health professional considered the event to be probably related to BENLYSTA. The health professional considered the event to be disabling and clinically significant (or requiring intervention). Additional information has been requested.
DEVELOPED ADENOPATHY AT BASE OF NECK ON THE SAME SIDE AS SMALLPOX VACCINE.
pt was difficult to arouse during the noc when was pale, cyanotic around mouth;had apnea episodes x2 during t99.4 ax;was sleeping in prone position;MD exam 11AUG97 AM determined to be possible pertussis rxn or possible near SIDS episode;
local rash; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of RASH (local rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (local rash). At the time of the report, RASH (local rash) 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.   Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
The patient received vaccine at 13:42  and went to the Observation tent to sit for by  14:05. Patient started to complain to Observer about warmth at injection sensation  going up into side of neck and nausea, cough, anxiety. Patient was moved to the ED. Patient received a  Intramuscular injection of Diphenhydramine of 25 mg(0.5mL)
Patient reports itchy tongue ad throat, feeling a slight tightness in her throat and dizziness within minutes after receiving her 1st Pfizer vaccine on April 1, 2021. Patient reports having an allergic reaction to a chemo medication but could not remember the name. Patient was administered 50mg benadryl by EMS. Vitals were taken and within normal limits. Patient did not appear in any distress and texting during her examination. Throat was without erythema and swelling.  Patient reported some relief of her symptoms after 10 minutes of Benadryl but not resolved. Patient was later transported to hospital by EMS for further evaluation.
Patient perceived reaction at injection site, area appeared red, slightly swollen and warm to touch , area approximately 1 in by 2 in in size.  Suggested OTC pain relief and ice to area. Appears to be normal reaction to IM injection not requiring medical attention
Pt reports expected soreness with some redness and swelling. Approximately 2.5 weeks after second SHINGRIX dose she experienced blistering on the shoulder near injection site. She ended up with 2 large blisters (lemon-sized) which broke open and scabbed. Blister sites have become infected and pt has been to her doctor and received an Rx for antibiotic cream.
received another 50% more vaccine; A spontaneous report  was received from a nurse concerning a 72-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt vaccine rolling down her arm. The nurse told her that in that case, their protocol was to administer another 50% dose which she received.  The patient's medical history was not provided. Concomitant medications was not provided by the reporter.     On 18 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number:010M20A) intramuscularly for prophylaxis of COVID-19 infection.    On18 JAN 2021, patient received her first injection of Moderna vaccine and she felt the vaccine rolling down her arm. The nurse told her that in that case, their protocol was to administer another 50% dose which she received.   Action taken with mRNA-1273 in response to the events was not reported.   The event, vaccine rolling down her arm and received another 50%more vaccine was considered recovered/resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
Syncope times 5 at home starting at 630 am.  Called 911.  Syncope 2 times at hospital.  Hospitalized 2 days until it subsided. Blood pressure kept dropping and heart rate kept spiking.  Had chills and aches off and on for 48 hours. orthostatic hypotension.  It?s now been 5 days since being released and I?m still dizzy. Feels like I?m off balance/vertigo. Syncope has subsided but dizziness is still present.
Bleeding through the band aid; Started bleeding in the area where she stuck it in; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 01Apr2021 as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 01Apr2021, the patient experienced bleeding through the band aid/started bleeding in the area where she stuck it in (as reported). The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A fast heartbeat; Dizziness; Weakness; This is a spontaneous report from Medical information team. A contactable consumer (patient) reported that a 55-year-old (same age at vaccination) female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot: EW0191) intramuscularly on 22May2021 as single dose in arm left for COVID-19 immunization/ preventative. Medical history reported was ongoing knee disability, she does not take any prescription medication for this, once in a while takes ibuprofen for pain. Diagnosed when she was 2 years old, ongoing thyroid developed as an adult (her mother had a thyroid condition), at least 20 years ago or so, ongoing allergies, breathing difficulties and sarcoidosis in her lungs. Concomitant medications reported was levothyroxine sodium (SYNTHROID, Tablet) orally and ongoing at 25mcg daily for thyroid and fexofenadine hydrochloride (ALLEGRA) for allergies in the morning. She will sneeze a lot if she does not take it. There were none additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks were reported. She explained since then, she has been experiencing a fast heartbeat, dizziness, and weakness. She asked if her symptoms, should continue for that long, now that it has been 13 days. Patient asked if she should get the second dose of the Pfizer-BioNTech COVID-19 vaccine if the side effects from the first dose persist. Around the day after the first dose, she thinks all the symptoms started, clarified all symptoms started Sunday 23May2021. It is not as much, but still enough that she can tell. For the first few days, almost first week even at night she was having it, at night she will still have the fast heartbeat. And now she was able to sleep through the night and when she wakes up the fast heartbeat will happen, it was not continuous but frequent enough during the day. She confirmed all the symptoms have slightly improved. Patient declined any treatment, she kept thinking it will go away. She takes two medications other supplements like vitamin b. In 2009 she was diagnosed with sarcoidosis in her lungs but was not given active treatment. They did tests and told her it was almost in remission and she would go in for check-ups. Two years ago, they told her she did not need any more check-ups, it is not active. The first year when she had breathing difficulties, she was given a medication and she was to take one puff of it and that was it. Stated it was not an inhaler or spray. It was a minimal dose that had a steroid in it, and she was concerned about the steroid. It was oral and she only used it as a precaution and to help with breathing. Her breathing issue went away as soon as she lost weight, so not sure if breathing issue was sarcoidosis or being overweight. The reporter assessed seriousness as non-serious. Outcome of the events was recovering.  No follow-up attempts possible. No further information expected.
swelling, erythema, pruritus started 9/12/06 evening on left deltoid area of arm.  Treated: BENADRYL 25 mg every 6 hours.
Had COVID 19 in November 2020 and again in May 2021. Came to hospital with complaint of worsening shortness of breath associated with cough and sputum expectoration. Recently discharged for recurrent pneumonia. WBC 20. Started on ceftriaxone, azithromycin and dexamethasone. Placed on 2L NC. Diagnosed with community acquired bacterial pneumonia. Had VRE bacteremia. Switched to daptomycin and discharged on linezolid x 10 days. Readmitted on 5/29/21 with SOB, cough, and new left-sided pneumonia. Discharged 6/9/21. Admitted again on 6/10/21 for aspiration pneumonia and CHF exacerbation. Placed on unasyn and discharged on augmentin. Admitted again on 6/28/21 for sepsis secondary to pneumonia. Went comfort measures at this time and discharged  with hospice. Died 7/15/21
Rapid test and she was positive/ Covid Quantitative Ab's were positive; Rapid test and she was positive/ Covid Quantitative Ab's were positive; not feeling well; This is a spontaneous report from a contactable physician. A 13-year-old female patient received BNT162B2(COMIRNATY), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient who had the vaccine series a month prior to this report. She was not feeling well at school and they did a Rapid test and she was positive in 2021. Saw her in the office and she had no fever and a mild cough. Her Covid Quantitative Ab's were positive in 2021. This at least indicates she had a response to the vaccine as this positive rapid test indicating infection is too soon to trigger a response and she has not had prior Symptoms suggestive of Covid. The outcome of event was unknown.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Case number PHEH2015US003159, is an initial spontaneous report received from a nurse on 10 Feb 2015. This report refers to a 17 years old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. On 29 Jan 2015, the patient received MENVEO (batch number: M14701, expiry date: Nov 2015) at a dose of 0.5 ml intramuscularly. It was reported that the patient received the vaccine that was frozen with excursions as follows: on 14 Jan 2015, the vaccine was 0.4 degree Celsius for 1 hour and 16 minutes and on 26 Jan 2015, the vaccine was 0.8 degree Celsius for 36 minutes. No adverse events were reported following the maladministration.
Pfizer Bivalent/14Oct2023; Mild-to-moderate arm pain; Mild-to-moderate arthralgia; Mild-to-moderate myalgia; Moderate fatigue; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2023 at 15:30 as dose 5 (booster), single (Lot number: 4665) intramuscular, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 14Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for influenza immunisation. The patient didn't receive bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)). The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "seasonal allergy" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL; NEXIUM [ESOMEPRAZOLE SODIUM]; DYMISTA. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2; Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3 (Booster); Manufacturer Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4 (Booster); Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 14Oct2023 at 15:30, outcome "unknown", described as "Pfizer Bivalent/14Oct2023"; PAIN IN EXTREMITY (non-serious) with onset Oct2023, outcome "not recovered", described as "Mild-to-moderate arm pain"; ARTHRALGIA (non-serious) with onset Oct2023, outcome "not recovered", described as "Mild-to-moderate arthralgia"; MYALGIA (non-serious) with onset Oct2023, outcome "not recovered", described as "Mild-to-moderate myalgia"; FATIGUE (non-serious) with onset Oct2023, outcome "not recovered", described as "Moderate fatigue". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, myalgia, fatigue.  Additional information: covid did not occur prior vaccination. Covid not tested post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300330651 same reporter/product; different patient;US-PFIZER INC-202300330630 same reporter/product; different patient;
(unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced CHROMATURIA (Dark colored urine off and on). At the time of the report, CHROMATURIA (Dark colored urine off and on) had not resolved. Unknown          Concomitant product use was not provided by the reporter.  The patient did not had any issue after receiving the first dose.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
I was fine until 11 days later, when I developed Bells Palsy. I went to my NP and I got prescriptions for high dose steroids. I had it for about 3 weeks. I have some residual numbness on the right side of my face, but my motor nerves are intact.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 03-OCT-2017, the patient was vaccinated with PNEUMOVAX 23, 1 dose, lot# reported as R73811, expiration date: 18-MAY-2018, for prophylaxis (route of administration was not reported). Other suspect therapies included ROTATEQ 1 dose, orally, lot# M038717, expiration date: 26-SEP-2019, for prophylaxis and PEDVAXHIB 1 dose, lot# M046133, expiration date: 26-SEP-2019 for prophylaxis (route of administration was not provided). No adverse effects were reported. The vaccines experienced a temperature excursion between 32 Fahrenheit degrees and 35 Fahrenheit degrees within the average temperature of 33.1 Fahrenheit degrees for 14 hours. Digital Data Logger was not involved. There was no previous temperature excursion. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1710USA002363.
Diarrhea x 5 days Vomiting x 1 episode 24 hrs later Would not walk x 48 hrs after vaccine erythema & edema at site of vaccine x 48 hrs No other contact or person at home with gastroenteritis symptoms
Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced ILLNESS (Sick). At the time of the report, ILLNESS (Sick) outcome was unknown.            The action taken with mRNA-1273 in response to the event was not applicable. No concomitant medication information was provided. No treatment product information was provided.
Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient 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: DRUG INEFFECTIVE (death), SUSPECTED COVID-19 (death), outcome "fatal" and all described as "Covid". The patient date of death was Mar2023. Reported cause of death: "Covid". It was not reported if an autopsy was performed.  Clinical course: the reporter's wife (patient) was living in a rehab hospital and nurse that gave her and the reporter COVID but the reporter had a very mild case because of the fact that he had been inoculated and unfortunately his wife (patient) passed away on the march of this year (Mar2023).   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Covid; Covid
Approximately 8pm on 1.21.15 patient began to experience pain from elbow to wrist and numbness from the shoulder to finger tips. Numbness comes and goes. Pain is constant. Seen in office 1-23-15. On 1-26-15, per mother symptoms unchanged. Coming for recheck 1-27-15
Patient developed malaise, headache, extreme fatigue and aches/pains, 24 hours post-vaccination.
Chills; Slight headache; This is a spontaneous report from a contactable Nurse reporting for herself. A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ej1686), via an unspecified route of administration on 16Jan2021 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. Patient age at time of vaccination was 52 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EI1284), administered on 26Dec2020 in left arm. Medical history included depression and anxiety. The patient had no known allergies. Concomitant medication included bupropion hydrochloride (WELLBUTRIN). On 16Jan2021 the patient experienced chills and slight headache. No treatment was given for the events. The patient recovered from the events on an unspecified date in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19.
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection)was received from a healthcare professional regarding a 24 month old female patient who experienced warmness, redness and swelling at the injection site. At 24 months of age, the patient received a dose on 3/16/2005. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 3/16/2005. Dose regimen was 1 dose. Patient was not taking concomitant therapy. The patient experienced redness (injection site erythema), swelling, and warmness at the injection site right thigh in Mar 2005. The patient was considered recovered 2005. No additional information was available at the time of this report. The reporter also stated that another patient also received this same lot number and developed the same reaction (see case HQWYE632401APR05).
TIGHTNESS IN BODY; BODY SORES; BODY CHILLS; BODY ACHES; TIREDNESS; COLD HANDS; SORE THROAT; This spontaneous report received from a patient concerned a 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, intramuscular, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced tightness in body. On 09-MAR-2021, the subject experienced body sores. On 09-MAR-2021, the subject experienced body chills. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced tiredness. On 09-MAR-2021, the subject experienced cold hands. On 09-MAR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tightness in body, body sores, body chills, body aches, tiredness, cold hands, and sore throat. This report was non-serious.
Received call from client. She states within 1 hour of receiving vaccine left arm started aching. Within 24 hours of injection, the site was swollen and red and tender to touch. Did not do any treatments (cool compresses). Today, client stated injection site is not swollen, red area is about 2 inches long and a little tender to touch. Client states left arm feels much better. Explained to client this is some possible side effects of Zostavax. She stated: "Yes. I know that but I thought you would want to know."
Nausea, vomiting, moderate fever, chills, full body muscle aches.