chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from Pfizer (#2015272178) on 18-AUG-2015. This spontaneous report as received from a pharmacist refers to an adult patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the practice accidentally gave the patient a dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported). The patient was supposed to received a dose of PREVNAR 13. The outcome of the adverse event was unknown. The relatedness between the adverse event and the PNEUMOVAX 23 was not reported. Additional information has been requested.
Arm soreness; Dry heaves; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), RETCHING (Dry heaves) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), RETCHING (Dry heaves) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Thursday afternoon. At the time of the report, PAIN IN EXTREMITY (Arm soreness), RETCHING (Dry heaves) and NAUSEA (Nausea) outcome was unknown.            This case was linked to MOD-2021-036177 (Patient Link).
1st dose: pins and needles in arms legs and face, twitching. Subsided after 2 weeks.   2nd dose: pins and needles, numbness, spasms, half of body going numb, loss of control of bladder.
Received the Moderna Covid 19 vaccine from a vial that had already expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine from a vial that had already expired) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine from a vial that had already expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine from a vial that had already expired) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.     Vaccine expiration date: 02-Apr-2022.   This case was linked to MOD-2022-543435 (Patient Link).
On 05/15/2021- woke up with a swelling in my left leg, and a nagging in the left calf. Kind of a nagging mild pain.  Sunday, and Monday were not so bad, I went to work on Monday, I exercised and lifted weights. On Tuesday, it was still about the same. On Wednesday, I went for a walk, I thought the exercise would help. On Wed. 05/19/2021, significant swelling in the left leg, and nagging, like a muscle pull or tear, a consistent discomfort. I decided to go to the ER. They did a Doppler study- they saw a blood clot in the left leg. They put me on Eliquis, the standard for blood clots, and they said I could go home from there. I have been on the Eliquis for the last 8 months. I am still on the Eliquis. I have a follow up study in February 2022. I have not had any more issues with the leg.
Received GARDASIL in right deltoid & MENACTRA in left deltoid on 06/30/08, Monday. Monday afternoon started with Flu-like symptoms. Fever & chills, swelling right arm, body aches. No redness at injection site but swelling.
Anthrax injection given 01 Sept 2004.  This was the 5th in the series.  The 4th in the series was given in year 2000, which was four years prior to the 5th injection.  I advised the technician that my last injection was in 2000 and I was assured that there was no problem to have the 5th injection. One week after the injection, I started to experience malaise, fever, backache, joint-aches.  These symptoms escalated for another week until I registered a fever of 103 F.  I went to the base-hospital and was told that there was no link to the injection.  I requested a script of Clindimycin.  My symptoms quickly resolved in 2-4 days.
Within 5 minutes of vaccine administration, patient felt lightheaded, went pale and suffered low BP.  Within 15 minutes she recovered after ice pack to head, salty fluid and lying down. Recheck BP improved.  2 hours later-she got flushed & lightheaded again at school, bluish, reseen by MD-fine now with N BP.  Fatigued only.
Symptoms of Covid arm beginning a few hours after injection. Redness, swelling to area roughly three inches in diameter. By day 3 entire upper arm red. Patient also experiencing nausea, aches, and rashes on armpit and back of neck.
Postural Orthosthatic Tachycardia Syndrome; This spontaneous report was received from a consumer regarding a case in litigation, referring to a patient of unknown age and gender. Information about the patient medical history, concomitant medications, drug allergies or reactions was not provided.  On an unknown date,  the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), for prophylaxis (2 doses, scheme , dose, administration route, lot number and expiry date were not provided).  On an unknown date, after the two shots the patient experienced postural orthostatic tachycardia syndrome (POTS).    The outcome of postural orthostatic tachycardia syndrome was unknown.   The reporter considered postural orthostatic tachycardia syndrome to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL).  This is one o 2 cases from the same reporter.; Sender's Comments:  US-009507513-2303USA007746: US-009507513-2303USA007759:
Arm pain at the site of injection; This is a spontaneous report received from a contactable consumer from a sales representative. The reporter is the patient.  A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: IRBESARTAN; HCTZ; METOPROLOL; DOXAZOSIN. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Arm pain at the site of injection".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a patient (unknown gender and age). No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated by a physician at a healthcare facility/office with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 15-AUG-2016, the patient was treated by a physician at a healthcare facility/office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  Causality assessment was related. The outcome of the events was unknown. Additional information has been requested.
Redness, swelling, warmth, itchy began within 24hrs of injection. Treated with ice. Presents 4 days later with improvement.
No additional adverse events; The caller reported a supported temperature excursion for PROQUAD (lot: U006313, expiration: 24AUG2022) which has been administered.; This spontaneous report was received from a nurse, referring to a 5-year-old male patient. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 27-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number U006313 had been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA), expiration date reported and upon internal validation established as 24-AUG-2022) as prophylaxis (product storage error).  The administered dose of the vaccine was stored in a temperature of 38.8 degrees Fahrenheit (F) for 8 hours 0 minutes and 0 seconds. There was no previous temperature excursion reported. It was unknown if a digital data logger was involved. No adverse events were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA008073: US-009507513-2108USA007980:
Pelvic pain; Stomach pain/ache; Pain is very bad, goes from 5 to 7 and 8, Pain getting worse everyday; Hard time standing on feet; Lower back pain; Will not get second dose of the Moderna COVID-19 vaccine; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PELVIC PAIN (Pelvic pain), ABDOMINAL PAIN UPPER (Stomach pain/ache), PAIN (Pain is very bad, goes from 5 to 7 and 8, Pain getting worse everyday), DYSSTASIA (Hard time standing on feet) and BACK PAIN (Lower back pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced PELVIC PAIN (Pelvic pain), ABDOMINAL PAIN UPPER (Stomach pain/ache), PAIN (Pain is very bad, goes from 5 to 7 and 8, Pain getting worse everyday), DYSSTASIA (Hard time standing on feet), BACK PAIN (Lower back pain), PRODUCT DOSE OMISSION ISSUE (Will not get second dose of the Moderna COVID-19 vaccine) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN at a dose of 400 mg. On 30-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Will not get second dose of the Moderna COVID-19 vaccine) had resolved. At the time of the report, PELVIC PAIN (Pelvic pain), ABDOMINAL PAIN UPPER (Stomach pain/ache), DYSSTASIA (Hard time standing on feet), BACK PAIN (Lower back pain) and FATIGUE (Fatigue) outcome was unknown and PAIN (Pain is very bad, goes from 5 to 7 and 8, Pain getting worse everyday) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Blood test: normal (normal) normal. On 30-Apr-2021, Computerised tomogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.
13 minutes after given vaccine, patient told me her heart was racing. She went into a catatonic state and had difficulty communicating. I called and he said we would continue to monitor her, but let him know ASAP of any changes. She has been our patient for over a decade, so he was familiar with her history. She has a history of going into catatonic state in stressful situations. She was monitored closely, and about 15 minutes later, relayed to me that she was having difficulty breathing. Dr. was called again. and ordered 0.3 mg epinephrine and start IV. Both of these actions were taken and breathing improved quickly after epinephrine was given. Vitals were checked Q 15 throughout the event and remained stable. After about 90 minutes, patient began to talk more clearly. Her respirations became less labored. She told me she could feel her muscles relaxing. She was monitored for another hour and continued to improve. She was sent home with her husband another hour later.
After receiving vaccine, pt had vasovagal event and "fell out of" open car door, waking on ground. Intermittent vomiting x 30 min.
Lost feeling and use of legs for 5 mins Lung congestion Back Pelvic pain Exhaustion Headache Heavy menstruation after 1 1/2 yrs of no periods
c/o fast/hard HR, HR auscuitated, reg + strong rate of 66, no trouble breathing monitored.
PAIN IN UNILATERAL THYROID ON LEFT SIDE; MUSCLE PAIN; MILD SORENESS AT THE INJECTION SITE; FATIGUE; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-APR-2021, the subject experienced fatigue. On 04-APR-2021, the subject experienced mild soreness at the injection site. On 05-APR-2021, the subject experienced muscle pain. On 14-APR-2021, the subject experienced pain in unilateral thyroid on left side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 06-APR-2021, muscle pain on 08-APR-2021, and mild soreness at the injection site on APR-2021, and had not recovered from pain in unilateral thyroid on left side. This report was non-serious.
Localized redness and swelling at injection site that occurred almost immediately. Treated with ice and Benadryl observed for 30 minutes without respiratory compromise or increase in rash size 10-26-07 rechecked patient and doing fine.
pt recv vax when was pregnancy & had no adverse rxn;during pregnancy pt esp hyperemesis gravidarum;30MAY95 @ 40wk gestation delivered a 7lb 4oz healthy female;pt devel a sl hemorrhage during the vaginal delivery
Immediately after injection I had no pain.   I went to get tested and was positive for Covid.
1/6 got vaccine don?t hurt- Initially slightly sore arm a few hours after vaccine  1/7 Next day when woke up very sore arm and shoulder and  feeling not 100% 1/7 Mid morning, Headache, stuffy head, Body aches all over, joint pain all over, chills, low grade fever 99/100 by noon, all of these side effects lasted 1/8 and subsided into 1/9 feeling almost 100% better 1/10
Mo took pt to ER 3-4 hrs p/vax given; mom reported pt felt warm & was shaking; ER MD determined pt did not have a sz, pt reported as alert; t104 R, P162, R40; neg exam reported;
Got worse; Overdosed; Sleep deprived for so long; Couldn't function; Felt suicidal/Wanted commit suicide (described as the patient overdosed); Tinnitus; Head tremors; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of INTENTIONAL OVERDOSE (Overdosed), TINNITUS (Tinnitus), HEAD TITUBATION (Head tremors), SLEEP DEFICIT (Sleep deprived for so long), IMPAIRED WORK ABILITY (Couldn't function) and CONDITION AGGRAVATED (Got worse) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced TINNITUS (Tinnitus) (seriousness criterion hospitalization) and HEAD TITUBATION (Head tremors) (seriousness criterion hospitalization). In April 2021, the patient experienced INTENTIONAL OVERDOSE (Overdosed) (seriousness criterion hospitalization), SLEEP DEFICIT (Sleep deprived for so long) (seriousness criterion hospitalization) and IMPAIRED WORK ABILITY (Couldn't function) (seriousness criterion hospitalization). On an unknown date, the patient experienced CONDITION AGGRAVATED (Got worse) (seriousness criterion hospitalization). The patient was hospitalized from sometime in March 2021 to sometime in April 2021 due to CONDITION AGGRAVATED, then on sometime in March 2021 due to SUICIDAL IDEATION, then on 18-Apr-2021 due to HEAD TITUBATION, IMPAIRED WORK ABILITY, INTENTIONAL OVERDOSE, SLEEP DEFICIT and TINNITUS. At the time of the report, INTENTIONAL OVERDOSE (Overdosed), TINNITUS (Tinnitus), HEAD TITUBATION (Head tremors), SLEEP DEFICIT (Sleep deprived for so long), IMPAIRED WORK ABILITY (Couldn't function) and CONDITION AGGRAVATED (Got worse) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment for the event included stomach pumping, psychiatric medications and Vitamin D. The patient was initially hospitalized on an unknown date in Mar 2021 due to suicidal tendency and was discharged on an unknown date in Apr 2021, then readmitted on 18 Apr 2021 due to inability to work, tinnitus, head tremor and suicidal tendency. This case was linked to MOD-2021-100820 (Patient Link).; Sender's Comments: Very limited information regarding the events (Suicidal ideation and other events) has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the event (tinnitus), a causal relationship cannot be excluded. Additional information regarding medical history and concomitant medications are required for further evaluation.
Vaccine expired; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included Headache. Concurrent medical conditions included Obesity, Depression, Anxiety and Penicillin allergy (allergy to PCN). Concomitant products included HYDROXYZINE and FLUOXETINE for an unknown indication.   On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine expired) to be not related.    No treatment medications were provided.  The vaccines expired on 31-Aug-2021, there were two dates that the vaccine clinic was open, 03-Sep-2021 and 17-Sep-2021. The vials did not undergone a temperature excursion. The vials were removed from the freezer on the day of vaccination. This lot number expiration date was not extended.   This case was linked to MOD-2021-328706 (Patient Link).
Information has been received from a pharmacist concerning a female patient who was vaccinated with Recombivax HB. Subsequently the patient developed hives. The patient sought medical attention via telephone. Subsequently, the patient recovered from the hives. Additional information has been requested.
Patient fainted within 15 minutes of vaccination.  She had not eaten that day.  Given some food; no treatment needed and she was released to home with a parent.
unilateral swelling of the face and RUE w/o erythema, SOB/flushing/malaise.
Report received from a PharmD on 27-Oct-2008.  An employee received AFLURIA (CSL influenza vaccine, data of administration unknown).  At unknown time after administration, the patient developed localized reactions at the injection site 2-4 inches in diameter.  The site was red and circular, warm, and puffy.  The employee received a prefilled syringe.  (The report concerned two patients.  For other patient, see case 200814226).  Additional information has been requested.  ASSESSMENT:  No serious criteria mentioned.  Causality: unassessable/unclassifiable.  Follow-up information was received on 11-Nov-2008 from the PharmD.  Per the PharmD, he will not be providing any additional details as he discussed the case with the hospital nurse and they decided the events were within the expected and listed ADRs.  No change in assessment.  Information derived from this AE report dies not change the current safety profile of AFLURIA (FLUVAX).
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe
Fever of 101.6 degrees F starting at 11:00am 4/6/2021 through the night. Fever concluded the next day. 48 hours after 2nd dose, slight feelings of nausea, like about to throw up. Nausea only lasted less than a day. 24-36 hours after second dose, slight feelings of forgetfulness and confusion. Concluded after 4/6/2021.
VACCINE DRAWN UP DAY BEFORE AND GIVEN AT THE 15 HOUR MARK. PER MODERANA CLIENT TO BE CALLED TO SEE IF ANY ADVERSE REACTIONS . CLIENT COMPLAINTS OF FEVER AND ACHINESS LASTING 1 DAY.
About 36 hours post vaccination patient reported rash around the injection site and the area was hot/tender to the touch. Patient iced area, took APAP and notified her PCP. She also reported the expected reactions of low grade fever, headache, fatigue and chills.
Fairly rapid onset of excess fatigue, difficulty keeping eyes open associated with oscillating vision, near simultaneous distortion of sound (at the time was watching a show using my phone, and the actors no longer sounded like themselves), sense of subtle disequilibrium, and a sense of intense heat involving my upper abdomen and lower chest, centered around my xiphoid process as if being pressed up against a space heater, the latter symptom was non-painful, perhaps the best example is the feeling one has after receiving intravenous contrast dye for CT imaging although more the "warmth" was more intense. Lasted 90-120 minutes before going to sleep, then gone by morning.