chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; fever; tired; red spot on arm; large bump on arm; nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Jan2023 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 18Jan2023 at 16:00, outcome "recovering"; PYREXIA (non-serious) with onset 18Jan2023 at 16:00, outcome "recovering", described as "fever"; SKIN DISORDER (non-serious) with onset 18Jan2023 at 16:00, outcome "recovering", described as "large bump on arm"; NAUSEA (non-serious) with onset 18Jan2023 at 16:00, outcome "recovering", described as "nauseous"; MACULE (non-serious) with onset 18Jan2023 at 16:00, outcome "recovering", described as "red spot on arm"; FATIGUE (non-serious) with onset 18Jan2023 at 16:00, outcome "recovering", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, pyrexia, fatigue, macule, skin disorder, nausea.  Additional information: No other vaccine patient received in four weeks. Dose received was more than 3. . Headache fever tired red spot on arm large bump on arm nauseous. It was reported that Covid prior vaccination was yes. No Covid tested post vaccination.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This case was reported by a nurse via call center representative and described the occurrence of numbness of upper extremities in a 34-year-old female patient who received ENGERIX B Adult (batch number 35G7C, expiry date 1st February 2019). Concurrent medical conditions included tuberculosis (tested positive). On 6th February 2016, the patient received the 2nd dose of ENGERIX B Adult (intramuscular) 1 ml. On 7th February 2016, 1 days after receiving ENGERIX B Adult, the patient experienced numbness of upper extremities and tingling of extremity. On an unknown date, the outcome of the numbness of upper extremities and tingling of extremity were not recovered/not resolved. The reporter considered the numbness of upper extremities and tingling of extremity to be possibly related to ENGERIX B Adult. Additional details were provided as follows: The patient received a dose of ENGERIX B Adult on her left arm. The patient experienced numbness and tingling in the left arm. At the date of reporting, the patient reported that the numbness comes and goes and it feels as if it was going up to her neck.
Burning sensation in his right foot and that is the same side he had vaccine on; He starts feel bad; This is a spontaneous report received from a contactable reporter (Consumer).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BURNING SENSATION (non-serious), outcome "unknown", described as "Burning sensation in his right foot and that is the same side he had vaccine on"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "He starts feel bad".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
arm was swelled up, really hard, hurt, burned; arm was swelled up, really hard, hurt, burned; arm was swelled up, really hard, hurt, burned; arm was swelled up, really hard, hurt, burned/ burning up; freezing,shaking all over,tremors; muscle spasm in legs; chills; joints on neck side and back; terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swelled up, really hard, hurt, burned), PAIN IN EXTREMITY (arm was swelled up, really hard, hurt, burned), INDURATION (arm was swelled up, really hard, hurt, burned), BURNING SENSATION (arm was swelled up, really hard, hurt, burned/ burning up) and TREMOR (freezing,shaking all over,tremors) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045T21A, 0c2A21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FELODIPINE, LOSARTAN, LEVOTHYROXINE SODIUM (SYNTHROID), ALLOPURINOL, PRAVASTATIN and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm was swelled up, really hard, hurt, burned), PAIN IN EXTREMITY (arm was swelled up, really hard, hurt, burned), INDURATION (arm was swelled up, really hard, hurt, burned), BURNING SENSATION (arm was swelled up, really hard, hurt, burned/ burning up), TREMOR (freezing,shaking all over,tremors), MUSCLE SPASMS (muscle spasm in legs), CHILLS (chills), ARTHRALGIA (joints on neck side and back) and HEADACHE (terrible headache). At the time of the report, PERIPHERAL SWELLING (arm was swelled up, really hard, hurt, burned), PAIN IN EXTREMITY (arm was swelled up, really hard, hurt, burned), INDURATION (arm was swelled up, really hard, hurt, burned), BURNING SENSATION (arm was swelled up, really hard, hurt, burned/ burning up), TREMOR (freezing,shaking all over,tremors), MUSCLE SPASMS (muscle spasm in legs), CHILLS (chills), ARTHRALGIA (joints on neck side and back) and HEADACHE (terrible headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: 161 (High) blood sugars at high at 161..         No treatment medication information provided.
Left upper forearm/lower legs, both erythermatous. Maculo-papular rash, 5 vesicles/blisters.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced HEADACHE (headache). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) on 02-Mar-2021 for Headache, at an unspecified dose and frequency. On 02-Mar-2021, HEADACHE (headache) had resolved.            Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 in response to the events were not applicable.
lymphoma; Patient receieved it twice, on 10Jan2020 and other dose 28Sep2020 within 8 months; This is a spontaneous report from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs). A contactable healthcare professional reported that a patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date unknown), a single dose on 10Jan2020, and another single dose on 28Sep2020, both via an unspecified route of administration for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) twice, on 10Jan2020 and other dose 28Sep2020 within 8 months. The patient has lymphoma on an unspecified date but wasn't supposed to get it this close. The patient does not have symptoms. The reporter asked for any consequences. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lymphoma with PREVNAR 13 can not be fully excluded based on the limited information.  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.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 02-AUG-2017, the patient was vaccinated with one dose of improperly stored VARIVAX (lot # M033904, expiration date 20-JUL-2018, 0.5 ml, subcutaneous) for prophylaxis along with M-M-R II (lot # and expiration date were unknown) and hepatitis b virus vaccine (unspecified) (manufacturer unknown). The other two vaccines did not experience temperature excursion. No adverse effects were reported. The vaccine stored under -9 Celsius degree to 8 Celsius degree for 1 hour. Previous temperature excursion was -9 Celsius degree to 8 Celsius degree for 63 hours. Data logger was not involved.
a little bit sore; a patch which is bright pink; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (a little bit sore) and INJECTION SITE ERYTHEMA (a patch which is bright pink) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced INJECTION SITE PAIN (a little bit sore) and INJECTION SITE ERYTHEMA (a patch which is bright pink). At the time of the report, INJECTION SITE PAIN (a little bit sore) and INJECTION SITE ERYTHEMA (a patch which is bright pink) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient was scheduled to receive Pfizer Bivalent but received the Pfizer Monovalent form in error.  No adverse events were reported.
Ached all over for 2 days. Tenderness in the area. Very swollen under the armpit for 24 hours-difficult to bathe that evening very uncomfortable through the next day. Never had a rash on the affected arm. Felt more comfortable after 48 hours.
This is a spontaneous report from a contactable physician. A patient (sex and age unknown0 was administered a dose on PREVNAR13 by an unknown route of administration on an unknown date. Medical history was not reported. Concomitant medications were not reported. After vaccination , on an unknown date, the patient developed a rash on the thigh . The outcome was unknown.
Hives, started on abdomen, spread to back 8 hours later, 28 hours later to arm.  Took oral benadryl 28 hours after onset.
Covid breakthrough.  Was vaccinated with Janssen on 5/3/2021.  Presented with dry cough, HA and generalized weakness after Covid exposure.  Treated with steroids and Remdesivir.
I had lower back pain, I had pain on my right hip and my pelvis area (in the joints). It could be muscle or nerve pain. My doctor sent me for a physical therapy, I did that for the whole month of Dec, after holidays, still hurting, I had physical therapy for 3 months and he did ultrasound on me, MRI. On dec 2nd I went to a Urologist for the Bladder Spasm and the gynecologist, radiology and primary doctor. Tomorrow I will have another MRI to see where the pain is.
INJECTION SITE REDNESS AND PAIN; LOCALIZED ALLERGIC REACTION, ITCHING; TINGLING DOWN THROUGH FINGERS.
Pt. states that after receiving the 1st dose of Jansen J&J 05/21/2021, started experiencing symptoms 06/21/2021 of a Shingles breakout in the Left Eye and facial area. Diagnosed with Shingles 06/26/2021  Optometrist. Facial, Left eye, and Scalp area effected, still experiencing symptoms.
Patient presented to the ED  reports he has been coughing a lot. Had chest pain a few days prior but pain is gone by now. His daughter at bedside noted that his O2 waxes and wanes a lot and O2 dropped to 70s today. Pt lives with his wife but with her daughter, but she drove him to ED today.   Hospital Course   #Acute hypoxic respiratory failure #Severe Covid-19 infection # COVID-19 pneumonia -tested positive 1/18 at hospital -pt presented to ED 1/25 due to hypoxia -completed course of dexamethasone and remdesivir -Baricitinib added and continued until discharge. -He responded to treatment and was weaned off high-flow nasal cannula to RA at the time of discharge -patient was intermittently diuresed    Discharge Disposition/Condition Disposition: Home Condition: Stable (s/sx potential problems absent or manageable)
At the time of the vaccine, I experienced a hard breathing, my pressure & pulse went up and they kept me onsite for 45 minutes and then they let me go home. 36 hours after, I broke out with a rash all over my body, lower back & side of my caps, my hands & feet were clear. Hard red rash, spread gradually. I had a telephone visit and sent pictures and the doctor did not want me to have the 2nd shot.   (After 3rd dose I got COVID on feb 1st, 2022), had fever & chills, very exhausted for three days, oxygen level went down but with the breathing exercises went back to normal, I did not have to go to the doctor).
I was not feeling well and was feverish and achy. I was lethargic and did not have much energy and I had a headache. I took a COVID-19 home test and it was positive. I reached out to my health care provider and had a telehealth appointment and they had me take TYLENOL, rest, and get plenty of fluids, but did not give me the antiviral due to the medications that I take. My symptoms lasted about three days other than the lethargy which to this day I still struggle with the fatigue.
Fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 84 year-old male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 84 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "Fatigue". Therapeutic measures were not taken as a result of fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented 9 hours post vaccinations to the ER with a fever of 102 untreated. Provider ordered TYLENOL. Baby not given TYLENOL, no fever upon admission. Pt tx for hyponatremia poor mixing of formula. Increased white ct high. Pt discharged the next day.
Within 7 minutes: "Hives, burning in my arms, tingling in my arms, headache, high blood pressure, nausea, throat clogging and irritation type"
Mother phoned health dept on 11/15/00 and stated client has hives and itching that developed 3 hours, post vax, and had not resolved. Mother took client to MD on 11/15/00. Requested consent for release of information from MD to health dept. Received 1st flu shot in 1999 without complications per client's mother.
Fever, CHILLS Narrative: LOW GRADE FEVER AND CHILLS LASTED 12 HOURS
Extreme headache, experienced with both dose one and two; resulting in random  but historically  and employment significant memory loss.
FEVER; This spontaneous report received from a patient concerned an adult male. 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) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch or lot number. No concomitant medications were reported. On 22-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
I reported initial complaint of severe pain/stiffness in arm. On 10/7/13 but VAERS was unable to find claim. Today 6/25/14 she reports that she has had MRI's due to loss of range of motion, physical therapy and possible surgery in the future due to flu shot.
Tingling over face and head.  The redness noted knuckles, bilateral hands.  The noted large red areas both elbows and fine raised rash both arms, upper and lower.
my feet feel so cold like ice; tingling to my hands and feet/Hand & feet tingling; leg weakness; felt like my heart pounding and racing/ fast heart rate; feeling too sick; started to feel flu like; muscle pain; fatigue; The initial report was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 24Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse (patient herself). A 40-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via intramuscular route of administration in the left arm on 15Jan2021 09:15 AM at a single dose to prevent COVID-19. Medical history included known allergies: latex. Concomitant medications in two weeks included ergocalciferol (VIT D) and cyanocobalamin (VIT B12). The patient did not have any other vaccine in four weeks. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via intramuscular route of administration in the left arm on 26Dec2020 10:30 AM. She also previously took NYQUIL and experienced known allergies. The patient was not pregnant and was not diagnosed with COVID prior to vaccination. The patient stated "I started to feel flu like around 7pm on January 15th. I had extreme muscle pain and fatigue. I woke up at 2am with what felt like my heart pounding and racing. The fast heart rate lasted about an hour. For the next +5 days, I had extreme fatigue, taking 3 hour naps at a time and still suffering from muscle pain. I attempted to go to work a couple of those days but went home half way through my shift because I was feeling too sick. Friday morning, 22Jan, I woke up feeling like I had leg weakness but I was still able to do activity normally. Saturday morning, 23Jan, I woke up with tingling to my hands and feet. I even had trouble typing at work. I made it through my shift this day with waves of muscle pain, fatigue and constant tingling to my hands and feet. Today Sunday, 24Jan I still have hand & feet tingling and my feet feel so cold like ice. I still feel 'off' overall. I plan do see my PCP this week to discuss these new symptoms in my hands and feet." The patient did not receive treatment for the events. She was not tested for COVID post vaccination. The outcome of 'heart pounding and racing/ fast heart rate' was recovered, and of remaining events was not recovered.
Initial information received on 07-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 years old patient (unknown gender) who was given expired MENACTRA vaccine (expiry date 03 Jun 2018), with vaccine MENACTRA. The patient's past medical history, medical treatment, vaccination, concomitant medication and family history were not provided. It was an actual medication error due to expired vaccine used. On 06-Jun-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE with expiry date 03 Jun 2018 (Lot number not reported) via unknown route in unknown administration site. No lab data provided. It was unknown whether patient experienced any adverse reaction after the injection. 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. List of documents held by sender: none.
patient received FLUZONE QIV-PFS on 21Feb2023 and last injection on 30Jan2023 with no reported adverse event; Initial information received  on 22-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 months old male patient who received influenza quadrival A-B vaccine [Fluzone QIV] on 21-feb-2023 and last injection on 30-Jan-2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Jan-2023 he also received a dose 1 of the influenza quadrival A-B vaccine, suspension for injection (with an unknown: dose, strength,  batch number and expiry date) via unknown route in unknown administration site and on 21-Feb-2023, the patient received a 0.5 ml (dose 2) once (1X) of same vaccine (lot UT7731MA; expiration Date :30-Jun-2023)  via intramuscular route in the vastus lateralis (thigh nos.) (side not reported) for Immunization last injection on 30-Jan-2023 with no reported adverse event (inappropriate schedule of product administration) (latency: 22 days) following the first dose and (latency; on same day) from the last dose administration of quadrival A-B vaccine .  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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient received the shot on Thursday. Friday night at bedtime she noticed red places on her arm (NOT immediately surrounding the injection site) and the top of her shoulder. It was still there on Saturday. The places were not itchy but had heat and felt painful to the touch. Patient took BENADRYL and applied NEOSPORIN to the places. Monday all places were gone except for the one on the top of her shoulder which was fading and decreasing in size.
PATIENT WAS GIVEN 2ND VARICELLA AS NOTED; PATIENT WAS TAKEN TO ER ON SUNDAY (9/26/10) MORNING BY FAMILY DUE TO CHILD'S C/O PAIN IN THE RIGHT ARM. GRANDMOTHER STATES CHILD WAS GIVEN BENADRYL LIQUID AND RELEASED. PRESENTED TO HEALTH DEPARTMENT (9/27/10) SITE WHERE VACCINE GIVEN WAS STILL RED, SWOLLEN, SORE, AND HOT TO TOUCH. GRANDMOTHER TO CONTINUE BENADRYL AND TYLENOL AND WATCH FOR BREATHING PROBLEMS.
Severe soreness in shoulder starting the night of getting the vaccine.  then started with muscle weakness and pains all over.  Also felt numbness in hands and feet at times.