chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site of the injection started to burn as I sat in the waiting area.  The best way to describe the burning feeling in my arm  is the feeling of when you receive a local anesthetic or a nerve block at the dentist.  It lasted for 30 seconds to 1 minute .  I began to feel nauseous and hot, I broke into a sweat and called over someone as I felt like I was going to pass out.  All happened within the first 3 minutes in the waiting area.  I sat with the medics for a few minutes and I returned to normal.  I never lost consciousness.  I was able to leave after the 15 minutes.
Jynneos that had been punctured for at least eight hours was administered; Jynneos was administered intradermally with a vial that had been punctured for at least eight hours; Jynneos was administered intradermally; Case reference number US-BN-2022-002658 is a spontaneous case report initially received on 21-Sep-2022 from other health professional via Agency (reference number: USBAV22-1488) and concerns a male patient of an unknown age.  The patient's medical history and concomitant medication details were not provided.  On 20-Sep-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at a dose of 0.1 ml, administered intradermally at an unknown site of administration for monkeypox prophylaxis. The vaccine was administered with a vial that had been punctured for at least eight hours (explicitly coded as 'product storage error ', 'product administration error' and 'intradermal injection').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received on 22-Sep-2022 included local BN case ID.; Reporter's Comments: A male patient of an unknown age was vaccinated with the first dose of Jynneos, administered intradermally at an unknown site of administration for monkeypox prophylaxis. The vaccine was administered with a vial that had been punctured for at least eight hours, which is considered as a product storage error and product administration error. No associated adverse events were reported. Intradermal injection, product storage error and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection, product storage error and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: A male patient of an unknown age was vaccinated with the first dose of Jynneos, administered intradermally at an unknown site of administration for monkeypox prophylaxis. The vaccine was administered with a vial that had been punctured for at least eight hours, which is considered as a product storage error and product administration error. No associated adverse events were reported. Intradermal injection, product storage error and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection, product storage error and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.
Received COVID-19 vaccine on 1/8/21 and 1/29/21.   On 4/23/21 the patient developed chills, cough, headache, loss of taste/smell, shortness of breath, and congestion.     Tested positive for COVID.  Treated with monoclonal antibodies (BAM/etesevimab).
1 mon after vax pt had major flare & systemic onset juvenile rheumatoid arthritis w/ pleuritis & pericarditis requiring corticosteroid treatment.
Redness (R) arm upon waking this morning. Pain and induration (L) arm, no fever.
Iodiopathic Transverse myelitis; This is a literature report for the following literature source(s):   A 75-year-old female patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, 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: MYELITIS TRANSVERSE (medically significant) with onset 24Jan2021, outcome "recovering", described as "Iodiopathic Transverse myelitis". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: unknown results, notes: nml; CSF cell count: 2 nucleated cells; CSF oligoclonal band: negative; CSF protein: 50 mg/dl; Exam findings: mild hyperreflexia in the left leg, notes: and a T5-6 sensory level; Magnetic resonance imaging: contrast enhancing lesion at T5; Magnetic resonance imaging head: normal; Magnetic resonance imaging spinal: normal. Therapeutic measures were taken as a result of myelitis transverse. Clinical courses: Acute left leg weakness and sensory loss and T10 senosry level, progressing to numbness and paresthesias in the right leg. Exam findings included mild hyperreflexia in the left leg and a T5-6 sensory level. Treated with IV methylprednisolone x5 days and transferred to rehab. Significantly improved with residual numbness in the left leg. Diagnosis: iodiopathic TM.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, a causal association between suspect drug and the reported event cannot be completely 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/drug, similar event and different patient;
I can hardly walk; If I sit down for a few minutes, I could hardly move them (knees); I've had pain ever since; knees are very painful/ His knees give him trouble all the time/pain in his both knees. It's pretty painful; starting having pain in my right arm where I had the second shot; not real good; pain in my right arm and still gets pain/pain in his right arm stuck with him; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (I can hardly walk), HYPOKINESIA (If I sit down for a few minutes, I could hardly move them (knees)), PAIN IN EXTREMITY (pain in my right arm and still gets pain/pain in his right arm stuck with him), FEELING ABNORMAL (not real good) and PAIN (I've had pain ever since) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in my right arm and still gets pain/pain in his right arm stuck with him). On 13-Sep-2021, the patient experienced FEELING ABNORMAL (not real good). On an unknown date, the patient experienced GAIT DISTURBANCE (I can hardly walk), HYPOKINESIA (If I sit down for a few minutes, I could hardly move them (knees)), PAIN (I've had pain ever since), ARTHRALGIA (knees are very painful/ His knees give him trouble all the time/pain in his both knees. It's pretty painful) and VACCINATION SITE PAIN (starting having pain in my right arm where I had the second shot). The patient was treated with VITAMIN D2 (oral) for Knee pain, at a dose of 50000 unit once a week. At the time of the report, GAIT DISTURBANCE (I can hardly walk), HYPOKINESIA (If I sit down for a few minutes, I could hardly move them (knees)), FEELING ABNORMAL (not real good), PAIN (I've had pain ever since) and ARTHRALGIA (knees are very painful/ His knees give him trouble all the time/pain in his both knees. It's pretty painful) outcome was unknown and PAIN IN EXTREMITY (pain in my right arm and still gets pain/pain in his right arm stuck with him) and VACCINATION SITE PAIN (starting having pain in my right arm where I had the second shot) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The patient reports taking the vitamin D2 50,000 unit capsules once a week, and he's into the sixth week now.  No relevant concomitant medications were reported.   This case was linked to MOD-2021-317664 (Patient Link).
This spontaneous report as received from a other health professional refers to a 2 month old patient.    On 19-JUN-2017 the patient was vaccinated with VAQTA lot # M047658 for prophylaxis. Other suspect therapies included RECOMBIVAX HB. On 19-JUN-2017, 1 day after onset of therapy the patient experienced wrong drug administered. On an unknown date the patient experienced no adverse event. The outcome of wrong drug administered and no adverse event is unknown. The reporter considered wrong drug administered to be not related to VAQTA and RECOMBIVAX HB. The reporter considered no adverse event to be not related RECOMBIVAX HB and VAQTA. {Additional information has been requested. / Additional information is not expected.}
Cheek (right) numbness/weakness , hard to explain the feeling as it has never happened before . I tried to smile and couldn?t without my face twitching . Right side continued until the next day . At random times I will get a twitch in that same side . Another is back pains right at my lungs on the left side that will cramp and then go away cramping last for 10 seconds (noticeably uncomfortable) about once an hour .
Fever, chills, body aches, fatigue. I felt like my mind was out of it like I was extremely tired. Took Tylenol and ibuprofen alternating throughout the day. Did not feel better until around 10pm the following day after vaccine.
Pain, heat and redness at site. Muscle weakness. Woozy feeling. Low grade fever. Rash.
acute voluminous diarrhea starting ~ 6 hours after vaccination, treated with conservative measures. improving by Day #3
Information has been received from a nurse practitioner concerning an approximately 20 year old female with no relevant medical history, no relevant concomitant medications and no relevant past drug history who on 11-MAR-2009 was vaccinated with the third dose of GARDASIL at about 12:00. The patient did not develop any adverse events after 2 doses of GARDASIL. On 12-MAR-2009, at approximately 02:00 am, the patient woke up with uncontrollable shaking and called the nurse practitioner. The nurse practitioner described the patient as being alert and able to talk. She recommended her to take an unknown dose of BENADRYL. As of 12-MAR-2009, the patient's uncontrollable shaking subsided after she took BENADRYL. Additional information has been requested.
Patient inadvertently received a 1.0 mL dose instead of the prescribed 0.5 mL dose. Patient was originally cleared to leave the office after having no symptoms or complaints for 15 minutes following inject. Once dose error was caught, patient was contacted by clinic physician, MD. Patient notified of error, possible side effects reviewed and advised to go to ER if symptoms develop. Patient had no current symptoms or complaints at that time. Staff followed up with patient several times over the course of the next 24 hours. Was unable to reach patient until 04/09/21 approx. 1030 am.  Patient doing OK, tired, but no other symptoms or complaints.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24May2022 as dose 1, single (Lot number: ER2613), on 17Mar2021 as dose 2, single (Lot number: EN6202), on 19Apr2022 as dose 3 (booster), single (Lot number: FJ4989) and on 09Nov2021 as dose 4 (booster), single (Lot number: FH330268D) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "overweight" (unspecified if ongoing); "heart issues" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; METFORMIN; ADVAIR; MONTELUKAST; FLUTICASONE PROPIONATE; AZELASTINE HCL. Past drug history included: Aspirin, reaction(s): "Allergy"; Sulfites, reaction(s): "Allergy"; Levofloxan 750 mg, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: It was reported that patient received vaccine, other medication in 2 weeks. Patient received treatment for COVID 19 with Paxlovid, Treatment start date on 20Aug2022, Lot number: GE4259.
Patient was given the vaccine and advised to wait 15 minutes in the pharmacy area. About 13 minutes into that time he fainted onto the chair next to him. help patient onto the floor and pharmacy staff assisted afterwards. called EMT and they came out to asses the patient. Patient was given OJ and some food and advised to remain in the pharmacy area an additional 15 minutes and to have another person drive him home.
On 11/4/16 it was discovered last years' FLUZONE QUADRIVALENT vaccine was administered. The expiration date was 30Jun16. No Known reaction. Vaccine manufacturer was notified.
This spontaneous report as received from a pharmacy technician refers to unspecified patients of unknown age. On an unknown date the unspecified patients were vaccinated with VARIVAX (Merck) (doses, routes, lot numbers not reported) that had been shipped between clinics on dry ice and possibly exposed to temperatures below -58F. No adverse effects reported. Additional information has been requested.
pain at injection site 8-9 hours later shaking, fever101.5, flu like symptoms, bone and muscle aches, heart palpitations, toes cramping. This lasted for about 3 hours
headache, nausea, abdominal pain, muscle aches, dizziness, hives, pain in the joints, fever, skin feels like it is burning
April 18 went to Er  dizziness, fatigue, chest pain  Released 4/21/2021,  unstable blood pressure ( high blood pressure. Given  atrovastatin high cholesterol, losartan 50 mg and metoprolol 25 mg
Developed fever to 102.2 last 2 days - treated with Tylenol & Advil.  Red spot on L thigh where got vaccines for 2-3 days.  Red spot on face also that is less now.  No cough or runny nose.  No V or D.  Drooling more.  Appetite and energy level are good.  Little fussy with temp yesterday.
Pt. is a 51  y/o  female reporting feeling she would pass out 15" into her 30" post-covid 19 first vaccine observation period.  Reports felt dizzy slightly immediately after vaccine injection then progressed in observation area.  Scheduled for 30" observation due to reported anaphylactic reaction per patient to Tylenol.  When first observed by physician in observation at 4:10,  nursing staff was holding her upright in chair, eyes were closed, face flushed markedly and a few myoclonic movements were noted in both arms.  She did open eyes to command but stated she was going to pass out and wanted to lie down.  A Emergency responders call was immediately placed, she was transferred into wheelchair with continued nursing support and brought into office where placed in supine position.  First vitals were as stated below.    4:15PM supine vitals:  BP 106/68, HR 95, O2 sat 99%   Emergency responders was called at 4:28pm
loss of her sense of taste and smell; loss of her sense of taste and smell; This is a spontaneous report from a contactable nurse (patient herself). A 53-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Since 29Dec2020, the patient had a loss of her sense of taste and smell that was unresolved. The patient wanted to know if this was a known side effect. The patient was not recovered from the events.  Information on the batch/lot number has been requested.
Information has been received from a physician concerning a 14 year old female who on 08-AUG-2007 was vaccinated with a first dose of Gardasil.  A few minutes after vaccination the patient felt dizzy and nauseous.  Unspecified medical attention was sought.  On 08-AUG-2007, the patient recovered.  No further information is available.
Episodes of feeling really bad, chest having extreme tension, heart flutters, tiredness, complete disorientation within these episodes. Slight disorientation event around 8/12/2021. No major events since. Feeling Better.
2x nodules 0.5x1cm each at anterior-lateral thigh at the site of vaccinaiton. Right thigh. Fussy acting like leg hurts since shots.
RN called to pt's bedside d/t pt's c/o dizziness/headache and diaphoresis. Pt's vital signs stable on assessment. No rash noted. Pt declined nausea/vomiting. Frequent vitals assessed. Drs notified. Order received to medicate pt. Benadryl 25 mg po given and Tylenol 650 mg po given. Pt remained on constant observation. Pt voiced relief after an hour and half of monitoring.
Patient received a pneumonia vaccine on 10/19/12 and later that evening her (R) arm started itching and swelling. The area of injection was red and warm to touch. Patient states her arm was sore to touch and movement.
Large injection site reaction which has enlarged to 12 cm x 7 cm by day 6. Tenderness but no pain. No induration, fluctuance, abscess.
patient was given an expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 23-Aug-2021 from an Other health care professional via Agency (Reference number- 00736347) and transmitted to Sanofi on 23-Aug-2021.  This case involves an 18-month-old female patient who was given an expired HIB (PRP/T) VACCINE [ACT-HIB] (Expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP).  On 23-Aug-2021, the patient received a 0.5 ml (total) dose of suspect HIB (PRP/T) VACCINE [lot UJ357AAA and expiry date 26-Jul-2021] via intramuscular route in left thigh for prophylactic vaccination.  It was reported, "A dose of ACT-HIB was given to a child which was expired. Caller is want to know what to do".  It was a case of actual medication error due to expired vaccine used (latency was on the same day).  At the time of reporting, patient had no adverse event.  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 seen in the ED on 7/3 after a possible fall. She was found down at home by her daughter. Overall patient was weak in the ED and had  some increased wheezing. She was given a nebulizer treatment in the ED and afterwards felt improved. A COVID-19 PCR test was done in the ED and found to be positive. Ultimately patient was admitted from 7/3 - 7/6 for COVID-19 infection with mild acute hypoxia. This meets criteria for vaccine breakthrough case review.
Chest pain approx. 1 week after injection. Chest pressure then random stabbing and squeezing pains following  chest tightness.
Pt woke up with red swollen feet, no peeling. Red papules on leg, trunk - worse today.
Child was given Pfizer for 12yrs +, 30mcg, instead of Pfizer for 5-11 year olds (10mcg) . Parents notified. Mother reports child had a headache and a light rash to torso which has resolved. Did not seek medical attention, did miss school.
pt recvd vax 14AUG95 & 11SEP95 pt devel 6 red areas which looked like mosquito bites, but were very hard; MD reported that the area did not look like varicella & described them as papular urticaria;no further details were provided;
Initially pain in left breast & underarm. Later breast pain resolved completely. Then experienced left arm numbness, shooting pain, weakness & limited movement that extends to hand & fingers. Will see neurologist later in month.
Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 05-JUN-2015 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. Throughout February 2016, patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. Patient was prescribed antivirals but continued to feel residual pain at the site of the outbreak. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
redness & itchy @ inj site 48-72 hr p/inj;unk prev immun;
After taking the vaccine, my left arm was slightly sore. Before taking a bath at night, I found a rash on the skin under the bra, which was neither painful nor itchy.  The next morning, I found that the rash began to spread on my body. I saw the doctor. The doctor said that I might be allergic to the vaccine, and gave me some common allergy medicine and ointment.  Afterwards, I noticed some rashes that were slightly crusted, but still spreading on my stomach, back, collarbone and buttocks.