chrisvoncsefalvay/vaers-outcomes huggingface dataset:
delivered on 25Mar2021, 7 weeks before her due date; Patient's mother was pregnant at the time, subsequently developed pre-eclampsia; This is a spontaneous report received from a contactable other Health Care Professional. This other health care professional reported information for both mother and fetus/baby. This is a fetus/baby report. A fetus male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose transplacental on 22Jan2021 (Batch/Lot number was not reported) as single dose, second dose transplacental on 18Feb2021 (Lot Number: EN6201) as single dose for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. Patient's mother was pregnant at the time, subsequently developed pre-eclampsia, and delivered on 25Mar2021, 7 weeks before her due date. The event outcome for events was unknown.; Sender's Comments: Based on the plausible temporal association, a contributory role of suspect product to the reported events 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 Regulatory Authorities, Ethics committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021372132 maternal case
Menstrual cycle started over a week early and was very heavy with visible clots, swollen lymph node on left side underarm
Patient with COPD here to receive her 1st dose of Moderna COVID vaccine.  Patient was feeling well prior and her husband states she has not had any breathing issues for 2 months. Approximately 10 minutes after receiving her immunization, she developed a dry, tight cough but lung sounds were initially clear.  Over the next 10 minutes she progressed to audible wheezing.  She took 3 puffs of her home albuterol inhaler.  Oxygen saturation was 99% but patient reported no improvement with her inhaler.  Acute bronchospasm secondary to vaccine administration  Patient was given albuterol 2.5 mg via nebulizer along with 25 mg Benadryl.  Following the nebulizer treatment, lung sounds were  once again clear, audible wheezing was gone, and patient was feeling back to baseline.  She  was given 125 mg Solumedrol to prevent relapse of symptoms.  Advised use of nebulizer  every 4 hours as needed today if cough or wheezing returns.  As for her second dose, we discussed pretreating with Benadryl 25 mg and an albuterol nebulizer treatment prior to  arriving. I would recommend she be monitored for 30 minutes when she receives it as well and be ready with Solumedrol and Epinephrine in the event she has issues.  Husband and patient encouraged to call back if worsening issues today.
This spontaneous report as received from a pharmacist refers to a 67 years old male patient with no medical history and no drug reaction/allergies. The patient was vaccinated with a dose of ZOSTAVAX in October 2012 (about two months ago). No other co-suspects were reported. There was no concomitant medication. The pharmacist noted the patient presented (on 26-DEC-2012) with a prescription for a three-day course of prednisone for some sneezing and coughing the patient had been experiencing. The date this sneezing and coughing began was unknown. There was no laboratory studies performed. The patient was prescribed prednisone by a physician. The outcome of sneezing and coughing was reported as not recovered/not resolved. Additional information has been requested.
Shingles - began with tingling/pain in left hip area on Tues May 18 and progressed to full rash outbreak by Thursday May 20.  Symptoms include pain at rash site and around the nerve line from mid-back to hip and around to front of hip in groin/pelvic region.  Itching, burning, and stabbing nerve shocks started the same day.  Treatment with valacyclovir.  The first day was within the six-week post vaccine period so I thought worth reporting.
Patient was given vaccine on 6/13/2019 but the vaccine expired in May 2019. No adverse reaction.
Three days after vaccination patient reached out to pharmacy to report that she had an area of persistent redness at the injection site that was about 2 inches in diameter and was itchy and hot to the touch.  I recommended she apply a cold-compress to the area, take acetaminophen for any pain, and apply hydrocortisone 1% cream to stop the itching.  I recommended that she monitor the size of the spot and call her doctor if the spot gets larger or does not resolve within 7 days or if she begins to run a fever.
pain + inflammation at site up to shoulder down to elbow. Could not raise arm. Other Rash + Hives
Information has been received from a physician concerning a male who on 29-MAY-2008 was vaccinated po with the third dose of ROTATEQ.  On 16-JUL-2008 the patient experienced intussusception.  Patient sought medical attention from physician.  The physician reported that the patient is "fine now".  The patient recovered from intussusception (date unspecified).  Upon internal review intussusception was determined to be an other important medical event.  Additional information has been requested.  9/10/08-records received for DOS 7/16 and 7/17/08-DX:Intussusception. Presented to ED with 1 1/2 days of vomiting, wretching and bloody mucus stool. Abdominal pain and decreased oral intake. Returned later in day to ED with C/O small speck of blood in stool and fussy. Referred for follow up to PCP.
I had a very strong reaction to the shots; I had an antibody test, and my antibodies were off the chart. I had very high levels of inflammation that happened twice. After the 2nd shot, I had extreme skin inflammation in the groin area. I tried home treatments with warm compresses and ibuprofen but that did not help. I contacted my doctor, and they recommended I go to a dermatologist. I saw the dermatologist in June of 2021. She did injections of KENALOG in June of 2021. I had injections every 3 visits for injections, and they attempted to drain it on the 2nd visit. It helped to reduce the symptoms and took a few months to resolve. Its currently in remission but could come back at any time. I have since had antibody level testing and the antibodies were extremely high. The levels were above 25,000.
chills; fever; headache lasting for two days; local right arm pain at injection site; began having tingleness in right arm from shoulder; Right Shoulder being dislocated; something wrong with right shoulder.; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), HEADACHE (headache lasting for two days), VACCINATION SITE PAIN (local right arm pain at injection site) and PARAESTHESIA (began having tingleness in right arm from shoulder) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced CHILLS (chills), PYREXIA (fever), HEADACHE (headache lasting for two days), VACCINATION SITE PAIN (local right arm pain at injection site), PARAESTHESIA (began having tingleness in right arm from shoulder), JOINT DISLOCATION (Right Shoulder being dislocated) and MUSCULOSKELETAL DISCOMFORT (something wrong with right shoulder.). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, CHILLS (chills), PYREXIA (fever), HEADACHE (headache lasting for two days), VACCINATION SITE PAIN (local right arm pain at injection site), PARAESTHESIA (began having tingleness in right arm from shoulder), JOINT DISLOCATION (Right Shoulder being dislocated) and MUSCULOSKELETAL DISCOMFORT (something wrong with right shoulder.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:32 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 62.73.  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 9 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
had a 24 hours reaction to the second dose; rundown; tired; low grade fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a 24 hours reaction to the second dose), MALAISE (rundown), FATIGUE (tired), PYREXIA (low grade fever) and MYALGIA (body aches) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A, 012L20A and 017F21A/012F21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION COMPLICATION (had a 24 hours reaction to the second dose), MALAISE (rundown), FATIGUE (tired), PYREXIA (low grade fever) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, bid. On 03-Mar-2021, VACCINATION COMPLICATION (had a 24 hours reaction to the second dose), MALAISE (rundown), FATIGUE (tired), PYREXIA (low grade fever) and MYALGIA (body aches) had resolved.            Concomitant medication includes high blood pressure medication.   This case was linked to MOD-2021-363444, MOD-2021-363015 (Patient Link).
swelling under his arm; inflammation under his arm: about 2 Inches x 3 Inches; fatigue; Excessive sleepiness; swelling of the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Excessive sleepiness), JOINT SWELLING (swelling of the shoulder), PERIPHERAL SWELLING (swelling under his arm), INFLAMMATION (inflammation under his arm: about 2 Inches x 3 Inches) and FATIGUE (fatigue) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No reported medical history.  Concomitant products included VITAMIN D NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced SOMNOLENCE (Excessive sleepiness), JOINT SWELLING (swelling of the shoulder) and FATIGUE (fatigue). On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling under his arm) and INFLAMMATION (inflammation under his arm: about 2 Inches x 3 Inches). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN 81) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Excessive sleepiness), JOINT SWELLING (swelling of the shoulder), PERIPHERAL SWELLING (swelling under his arm), INFLAMMATION (inflammation under his arm: about 2 Inches x 3 Inches) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
her left ear that is ringing; her skin hurt to the touch; weird static noise/ tinnitus, in her left ear; flu-like symptoms; chilled; her skin hurt to the touch; lethargic; This is a spontaneous report from a contactable consumer (Patient herself). A 71-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 05Feb2021 (at the age of 71-year-old) as single dose for covid-19 immunisation. Patient previously received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution injection; Batch/Lot number: EL8982), via an unspecified route of administration, administered in Arm Right on 15Jan2021 as single dose for covid-19 immunisation. Medical history included factor V leiden carrier from 2015 and ongoing. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) taken for factor V leiden carrier from 2015 and ongoing. Patient received no other vaccines on the day of her COVID vaccine. Caller stated that with her second dose, on the day of her second dose, 05Feb2021, maybe two hours after getting the second dose, she had this really weird static noise in her left ear, that she was hoping would go away, but it did not. Caller stated that same evening, she had flu-like symptoms, no fever but was chilled, and her skin hurt to the touch, and she was lethargic, the caller didn't get out of bed for a day and a half. Caller reported that the static in her ear started before she had the flu-like symptoms, but by Sunday, she was fine. Caller stated that she was hoping the static in her ear would go away, but it has not. Caller stated that the sound will sometimes disappear but then come back, but most of the time the sound was there. Caller stated that she thinks loud noises set it off. Caller was wondering if there have been any other people who have reported tinnitus after the vaccine. The outcome of the event weird static noise/ tinnitus, in her left ear was not recovered while the outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
14AUG92 pt devel cellulitis in the lt arm, site of vax given 11AGU92;
This spontaneous report was received from a medical assistant concerning an unknown number of patients of an unknown gender and age. On an unknown date, the patient were vaccinated with a dose of ROTATEQ (dose, dose number, lot number and expiration date were not reported) oral route. Co-suspect and concomitant therapies were not reported. The medical assistant reported dose of ROTATEQ that were exposed to a supported temperature excursion have been administered to unspecified patients on unspecified dates. No adverse effects have been observed or reported. This is one (1) of five (5) reports from the same source. Additional information has been requested.
Tooth infection; The initial tooth infection created abscess in the childs mouth which led to having multiple surgeries; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (Tooth infection) and TOOTH ABSCESS (The initial tooth infection created abscess in the childs mouth which led to having multiple surgeries) in a child female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TOOTH INFECTION (Tooth infection) (seriousness criterion hospitalization) and TOOTH ABSCESS (The initial tooth infection created abscess in the childs mouth which led to having multiple surgeries) (seriousness criterion hospitalization). The patient was treated with Surgery (Multiple surgeries) for Tooth abscess. At the time of the report, TOOTH INFECTION (Tooth infection) and TOOTH ABSCESS (The initial tooth infection created abscess in the childs mouth which led to having multiple surgeries) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient was hospitalized for health aliments inline with a tooth infection. It was reported that the child missed over 3 weeks of school as a result of symptoms. Treatment medication was not provided. Company Comment: This is a spontaneous case concerning child female patient with no reported medical history, who experienced the serious (hospitalization) unexpected, events of tooth infection and tooth abscess, which occurred on an unknown date and with unknown latency after a dose of mRNA-1273.222 (Original/Omicron BA.4/BA.5) vaccine (unknown COVID-19 vaccination schedule). It was reported that the initial tooth infection created abscess in the child´s mouth which led to having multiple surgeries. Child missed over 3 weeks of school because of symptoms. The outcome of the event was reported as recovered. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/BA.5) is not affected by this report.
Headache, Diarrhea, Injection site rash; chills Narrative:
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 22-FEB-2018, the patient was vaccinated with ROTATEQ (strength, dose and frequency were not reported) (lot # M005619, expiry date: 29-OCT-2018) orally for prophylaxis (product storage error). The vaccine was stored at 34 degrees Fahrenheit (F) for 12 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No additional information provided. There was no product quality complaint (PQC) reported. This is one of the 6 reports received from the same reporter. Lot number [M005619] is an invalid lot number for ROTATEQ. Sender's Comments: US-009507513-1803USA003815: US-009507513-1803USA003816: US-009507513-1803USA003817: US-009507513-1803USA003813: US-009507513-1803USA003594.
This spontaneous report was received from a registered nurse regarding a 1 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 19-JUL-2016, the patient was vaccinated with VARIVAX (strength, dose, route of administration, lot number and expiration date were not reported) or M-M-R II (strength, dose, route of administration, lot number and expiration date were not reported). The nurse could not confirm which vaccine was given to the patient and stated that "the vaccines may have been labeled wrong prior to administration". Additionally, a healthcare worker called asking if Merck could test the syringe, filled with the vaccine, to see what product was administered. On 19-JUL-2016 (the same day of vaccination), the patient experienced a reddened area that localized at the injection site (injection site erythema) and resolved within five minutes. The patient sought unknown type of medical attention and was unknown if a treatment was given for the event. No product quality complaint was involved. The outcome of injection site erythema was reported as recovered on 19-JUL-2016. The causal relationship between the event and VARIVAX and M-M-R II was unknown. Additional information has been requested.
recvd DTP inject @ 1215PM on 30JAN93; non-stop crying, uncontrollable, from the time recvd the inject until 4PM that day when parents called MD; No pertussis in the future;
Left arm pain in upper area since shot continues today. No pain at rest but noticed with arm movement.
After 2 days initial pain swelling  of injection site right arm only, and fatigue resolved   there  was  recurrence of itching rash erythema tenderness measuring 8x5 cm  at injection site area of right arm on 01/21/2021.    No fever.
Protracted headache  5/26/09 Received PCP medical records of 12/3/08-5/18/2009. FINAL DX:migraine HA; probable psychiatric illness Records reveal pt stated she was well on 12/3 for HPV #2.  RTC 2/26 w/HA, cold s/s, dizzy, light sensitivity.  Was on antibiotic prescribed by parent for presumed sinusitis.  Dx w/migraine, possible vertigo & presumed sinusitis.  HA persisted w/photophobia, phonophobia & nausea.  Missed several days of school.  Seen in ER 3/6/09 & Neuro consult done & dx migraine HA.  Initially responded well to meds but recurred on daily basis.  Outpatient Neuro eval 3/26, meds adjusted.  HA persisted w/4# wt loss & unsteady gait.  Added steroid pulse, labs & PT.  Neuro f/u 4/13/09 w/mild improvement.  Meds adjusted.  Neuro 2nd opinion suggested non-neuro findings, referred for psych & strongly encouraged to return to school even if using w/c.
Localized reaction, arm swelling injection site hard to touch. Patient developed fever chills. Stated she was sick in bed for 3 days.