chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching on her face, shoulders, back, arms, and thighs; They would raise up go from a red spot to a lump, crusted over, like poison ivy or poison oak does, like eczema or psoriasis; Red spot; Crusted over; Covered in red blotches. It's gone to the lower part of her legs: calves and shin areas; Shedding skin/ would leave a trail of where the welts had crusted and the skin started flaking off; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on her face, shoulders, back, arms, and thighs), SWELLING (They would raise up go from a red spot to a lump, crusted over, like poison ivy or poison oak does, like eczema or psoriasis), ERYTHEMA (Red spot), SCAB (Crusted over) and RASH MACULAR (Covered in red blotches. It's gone to the lower part of her legs: calves and shin areas) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PRURITUS (Itching on her face, shoulders, back, arms, and thighs), SWELLING (They would raise up go from a red spot to a lump, crusted over, like poison ivy or poison oak does, like eczema or psoriasis), ERYTHEMA (Red spot), SCAB (Crusted over), RASH MACULAR (Covered in red blotches. It's gone to the lower part of her legs: calves and shin areas) and SKIN EXFOLIATION (Shedding skin/ would leave a trail of where the welts had crusted and the skin started flaking off). The patient was treated with TRIAMCINOLONE ACETONIDE for Itching, at an unspecified dose and frequency; CYPROHEPTADINE (oral) at a dose of 4 mg at bedtime and ADALIMUMAB (HUMIRA) on 12-Aug-2021 at a dose of 40 mg every two weeks. At the time of the report, PRURITUS (Itching on her face, shoulders, back, arms, and thighs), SWELLING (They would raise up go from a red spot to a lump, crusted over, like poison ivy or poison oak does, like eczema or psoriasis), ERYTHEMA (Red spot) and SCAB (Crusted over) had not resolved and RASH MACULAR (Covered in red blotches. It's gone to the lower part of her legs: calves and shin areas) and SKIN EXFOLIATION (Shedding skin/ would leave a trail of where the welts had crusted and the skin started flaking off) outcome was unknown.            No concomitant medications were provided. After 2nd dose patient started breaking out in welts, but the welts have gone down, but it still itches.
pt recvd vax 16FEB93 & w/in 6 hrs of the vax pt exp severe swelling in arm, pain, erythema, chills & fever; pt was treated w/Lodine & Hismanal;
No adverse event; expired vaccine administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to patient) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     Patient doesn't have any allergies (medications, food and other products) and patient never tested COVID-19 positive test or diagnosis. Patient received no other vaccines within one month prior to Moderna COVID-19 vaccine. No history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.     On 23-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 23-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to patient).    Patients year of birth was reported.  No concomitant medication.  It was reported vial was in open carton in the freezer and vial size was 5.5 mL and vial had not undergone any temperature excursions. It was also on 23-SEP-2022 around 5pm the dose was administered to patient and adverse event had not caused patient to seek medical care (office visit, Urgent care, ER, hospitalized). It was reported that the reporter had not seen the vaccine expiration warning and later noted the expiry date. 2 primary full doses were administered to 2 patients. Reporter stated that the reporters colleague checked in with the patients to see how they were feeling and they had no complaints.     Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Live follow up received: updated reporter state, updated narrative.
Syncope approximately 4-5 minutes after injections. Stated "I can't see" then proceeded to lose consciousness momentarily. Medical assistant had been advised to stay in room after injection and fortunately was able to prevent patient from injury due to fall. MA supported patient onto exam table, NP called in to room to assist. Symptoms resolved spontaneously within seconds while lying supine, applied ice pack to forehead, elevated legs. Monitored, provided food/drinks. Observed for an additional 15 minutes. Vital signs rechecked, completely stable. Reported feeling completely fine within one or two minutes from episode.
Left arm pain numbness, stiffness. Nighttime increase in pain. L deltoid pain.
1320 Post vaccination experienced syncopal episode w/diaphoresis and episode of lethargy; Medical monitoring w/LE elevated, BP 84/62 P50 RR 16, O2 via NRM applied, po hydration consumed; 1330 BP 108/45 P70.  Declines ER evaluation/ treatment; reports "feels better"; released from facility w/ wife.
After my second dose I had an issue that I had to take medication for. It went away and then after my booster it came back. I had a CT scan in may that showed a blood clot in my liver. I also had Covid arm about a week after my second shot.
Pt received 2nd Moderna vaccine on 2/24/21.  Presented to hospital emergency department on 3/26/21 with complaint of syncope. Found to have acute pulmonary embolism in right lower lung lobe.
I have gotten the Pfizer vaccine and still ended up with COVID so I'm not the biggest fan of it.; I have gotten the Pfizer vaccine and still ended up with COVID so I'm not the biggest fan of it.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "I have gotten the Pfizer vaccine and still ended up with COVID so I'm not the biggest fan of it.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Menveo that was reconstituted with sterile water instead of the supplied CYW-135 liquid conjugate; Menveo administered reconstituted with sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA926A, expiry date 31-MAY-2024) for prophylaxis.   On 16-MAY-2023, the patient received Menveo. On 16-MAY-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo that was reconstituted with sterile water instead of the supplied CYW-135 liquid conjugate) and inappropriate dose of vaccine administered (Verbatim: Menveo administered reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-MAY-2023 The reporter reported that at the time of reporting the Menveo vaccine dose was not repeated. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Menveo reconstituted with sterile water instead of the supplied CYW-135 liquid conjugate, which led to Wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Dizziness, hot inside.  Patient stated that she is still feeling dizzy.  Pt. refused transport to hospital.  Pt. advised to call 911 and f/u with medical provider if symptoms persist.  Pt. A+Ox3.  Pt. verbalized understanding. O=100%, 190/106, BG 195, HR 108.
after a week of second shot neuropathy came back; after a week of second shot neuropathy came back; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Mar2021 (Batch/Lot Number: EN6207) as dose 2, single for COVID-19 immunisation. Medical history included anxiety, 2 years ago (2019) patient had chemotherapy and experienced neuropathy in feet and hands. Historical vaccine included 1st dose of BNT162B2 (Lot/batch number: EN6203) on 23Feb2021 for COVID-19 immunization and experienced static electric shock. Concomitant medication included duloxetine hydrochloride (CYMBALTA) taken for anxiety, start and stop date were not reported. 2 years ago (2019), patient did experience neuropathy in feet and hands. It was almost gone and after patient had the second shot, about after a week of second shot neuropathy came back and it really had gone much better and it started to fade again. It was almost like it was awakened but it was getting better. No treatment was received for the events. Outcome of the events was resolving.  Follow-up attempts are needed. Further information is expected.
Immediate pain at site of injection, which led to tenderness and swelling later and a feeling of warmth. Next day, extensive brusing/redness all the way down to the elbow.
pt recv vax 24JUL96 IM instead of SC & 24JUL96 pt devel a lump on thigh where the vax was administered;
On 01/01/21 woke up at 1am with worst chest pain I?ve ever had. I thought something was expanding in my chest or rupturing. I went to ER. Then on 01/04/21 I had the worst leg pains. I could hardly stand up. On 01/05/21 the pains continued badly with low grade temp and hives. I continued with hives and overall itchiness of my skin multiple times over a 4-6 week period needing Prednisone during one of those times.
Redness, hot on injection site ( L and M). Spread to L upper chest. 15 ml BENADRYL P.O. @ 5:50 pm.
Started to cough, red eyes with watery drainage, difficulty breathing, sore throat.  Used an inhaler and took Tylenol.  Saw acute care and was told to take Benadryl.
Fever; vomit next day; diarrhea 3 days; extreme pain shoulder; extreme pain arm 3 days; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Right on 19Feb2021 at 13:45 pm (at the age of 76-years-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing other (was Hospitalized with covid from 31Oct2021-11Apr2020) and ongoing blood pressure and thyroid disorder. Patient had no known allergies. Concomitant medications included unspecified medications for blood pressure and thyroid. Facility type vaccine was reported as doctor's office/urgent care. It was reported that patient received the first dose of vaccine and on 19Feb2021 at 16:00 pm experienced fever lasted 4 days, vomit next day, diarrhea 3 days and extreme pain shoulder, arm 3 days. Patient had not received any treatment to treat the event. Post vaccination patient had not tested for covid. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
left sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left sore arm) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included DULOXETINE, METOPROLOL, LOSARTAN, ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D [VITAMIN D NOS], MULTIVITAMIN [VITAMINS NOS] and APPLE CIDER VINEGAR for an unknown indication.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced PAIN IN EXTREMITY (left sore arm) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (left sore arm) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2021, Blood pressure measurement: 176/111 (High) high and 156/98 (abnormal) lowest blood pressure reported.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication hydralazine was just prescribed has not taken yet by the patient  as her doctor "just prescribed"
pt states that later the day of the vax that her left eye lid was dropping  and she had a blood blister develop a couple of inches below injection site.   The next day she had sore left arm with some fatigue. Pt states all symptoms have subsided but still has a droopy eyelid and has an apt w/ an eye doctor today.  She states she has had cataract eye surgery on 1/13/2021 and on 1/26/2021 had Botox injection on brow.  Pt has appt w/ PCP on 2/18/2021.
p/vax pt awoke that night from sleep w/rapid heart rate; sweating; anxious;
Patient administered expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medications were not reported.  It was reported that date the vial was initially stored in the refrigerator was 01-Oct-2021. The vial did not undergo any temperature excursions. Number of doses/vials was 1.
Patient received 1st dose of covid-19 vaccine however had received tetanus booster 9 days before. It was discovered after patient was given vaccine that she had marked "yes" on her questionnaire regarding the question about any vaccines in the last 14 days.
pt recvd vax; on 31aug94 pt started fever; t 103 on 1sep then 101-102; pt had h/a & swollen glands in neck; eyes reddened; on 5sep pt got rash all over body; at hosp; in ofc 6sep94 & MD thought rash may be an allergic rxn to amoxicillin;
DVT -- leg pain began the day after vaccination, patient was seen in the ER a week later and diagnosed with right leg DVT.  Started treatment with Eliquis.
This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis.  On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was unknown. It was unknown if the reporter considered the shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller reported that friend of hers, who was also the physician's assistant, told her they were getting a lot of patients in the emergency room with extreme shoulder pain after receiving SHINGRIX. This is 1 of 3 cases, reported by the same reporter.
Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain). At the time of the report, VACCINATION SITE PAIN (Injection site pain) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Company comment: 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.
Reportedly, this employee's mother died the night of the vaccine.  The details are not known at this time.
The day after the second dose was injected, my upper left arm was red, warm, painful, and swollen. The swelling was beyond the injection site and involved the whole muscle. The adverse event began to clear three days after the second dose was received. The redness, pain, warmth, and swelling  was significantly reduced.
Arm swelling, redness, and warmth on L arm around site of injection extending several inches in diameter
My first 2 doses of the vaccine were Moderna. Starting 07/15/2022, I had simple cold symptoms: cough, sneezing and nasal congestion. By that evening, I started feeling really tired and it felt different than a normal cold. I noticed that something more was the matter. The cough started getting worse and felt like acid was in my throat, almost like strep throat. The next day, I started running a low grade fever. That day, I called my doctor (07/16/2022) and was prescribed a steroid pack and Doxycycline and Hydrochloroquine. That Sunday (07/17/2022), I was very fatigued, couldn't stay awake and couldn't sleep well due to coughing and my throat was very sore. My temp went up to about 101.5. The next day, Monday 07/18/2022, my temperature returned to normal. I started feeling a lot better but my throat still hurt, my voice was hoarse and I had an intermittent headache. Yesterday, my temp came back and I was still very tired, my voice was hoarse and throat was still sore. Today, I have lost my sense of smell and things taste bland (no real taste to things). The fever is gone and I think I am well enough to go back to work tomorrow. I have been coughing up phlegm today.
On 4/23/01 the pt experienced 5cm x 3cm wheal at the injection site. On 4/24/01, there were erythematous areas surroudning ears and cheeks the left greater than the right. The injection site had a 6cm round indurated erythematous area. The pt had a temp of 100 axillary, treated with Motrin. On 4/25/01 the injection site was still induratied with redness, Motrin given again. Face and ears had rash. On 4/26/01 the injection had grown to 10cm round, was hot, indurated and had a hematoma.
I had swelling of my arms, legs, feet, face, eyes and throat. I was dizzy and my heart was racing. I had hives all over my body for many hours.  I have taken 2 rounds of Benadryl and it starting to go away.
Fever of 101-102.5.  Muscle aches all over.  Shivers and cloudiness.  Headache
Patient came to ED with other symptoms but was found to be Covid positive and short of breath on exam.  Patient admitted with respiratory failure due to Covid.
patient is currently pregnant with no reported adverse event; patient received an expired FLUZONE QIV NP with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 20 years old female pregnant patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] where patient received an expired fluzone qiv np with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported patient received an expired FLUZONE QIV NP with no reported adverse event occurred at 14 weeks of pregnancy during second pregnancy trimester for INFLUENZA QUADRIVAL A-B VACCINE.  The date of last menstrual period was reported as 11-Jun-2023. The estimated due date is 17-Mar-2024.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  On 11-Sep-2023, the patient received 0.5 ml (TOTAL) dose 1 of suspect influenza quadrival a-b vaccine Suspension for injection (batch number- UT7680NA and expiration date- 30-Jun-2023) via unknown route in unknown administration site (strength: not provided) for Immunisation (expired product administered) (latency- same day).  On an unknown date the patient is currently pregnant with no reported adverse event (exposure during pregnancy) (unknown latency).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for both the events.  Additionally, at time of reporting, the pregnancy is still ongoing.  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 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.
Severe and persistent joint pain in ankles, toes, wrists and fingers. Joint pain led to difficulty walking and inability to operate mouse/keyboard. Treated at urgent care with steroids. That relieved the pain but it returned within one week of ending the steroids. Became increasingly worse and was treated with steroids a second and third time. After third round of treatment, pain has not subsided but is less severe. Treatment continues. Symptoms remain.
04/21/2021: 4:00 am - Injection site soreness 10:00 am - Headache 11:30 am - nausea, muscle aches, chills, fatigue, aversion to food and fluids (forcing fluids anyway)