chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles, included any and all of its sequelae; shingles, included any and all of its sequelae; This spontaneous report was received from a lawyer regarding a case in litigation and referred to a 58-year-old female patient (pt). No information was provided regarding concomitant medications, concurrent conditions, or medical history. On or about 10-MAY-2017 (at 56 years old), the pt was administered zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route of administration, lot number and expiration date were not provided) by a healthcare provided (HCP) at a pharmacy as prophylaxis. As a result of her receipt of zoster vaccine live (ZOSTAVAX), on 11-JUL-2018, the pt was caused to suffer shingles (herpes zoster), including any and all of its sequelae (ill-defined disorder); the pt suffered severe personal injuries, pain, suffering, and emotional distress, and incurred substantial economic damages; which were all permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The pt required and/or would require more health care and services and incurred medical, health, incidental and related expenses. The pt was informed and believed and further alleges that she would in the future be required to obtain further medical and/or hospital care, attention, and services. Outcome of the events was not recovered. Causal relationship of the events reported as related to zoster vaccine live (ZOSTAVAX).  The reporter considered herpes zoster and ill-defined disorder to be disabling event.
Night of the vaccine, patient?s bones were aching. He broke out in a rash on cheek and an itchy rash in both his arms and face. He could not sleep for 2 days but the rash ceased 2 days later.
Immunization: COVID-19 PFizer-BioNtech 12yrs-adult, external - Pfizer vaccine was administered outside - reported by patient  I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 1/11/2022 COUGH, UNSPECIFIED I95.9 HYPOTENSION 9/10/2022 COUGH, UNSPECIFIED I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 1/11/2022 LETHARGY I95.9 HYPOTENSION 9/10/2022 LETHARGY I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 1/11/2022 IRON DEFICIENCY ANEMIA I95.9 HYPOTENSION 9/10/2022 IRON DEFICIENCY ANEMIA I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 1/11/2022 COVID-19 PNEUMONIA I95.9 HYPOTENSION 9/10/2022 COVID-19 PNEUMONIA I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 1/11/2022 HYPOTENSION DUE TO HEMODIALYSIS I95.9 HYPOTENSION 9/10/2022 HYPOTENSION DUE TO HEMODIALYSIS I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 1/11/2022 AORTIC VALVE STENOSIS I95.9 HYPOTENSION 9/10/2022 AORTIC VALVE STENOSIS I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 1/11/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION, W PSEUDOMONAS SEPTICEMIA I95.9 HYPOTENSION 9/10/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION, W PSEUDOMONAS SEPTICEMIA
Heaviest period I?ve ever had, early in cycle. Large clots. Extreme cramping. On day 5 and still large clots and cramping that has kept me up all night long almost unbearable. Bleeding through tampons in less than an hour.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) as single dose for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "She got swollen under her arm". Additional information: She reported that her husband, 62 years old, got their 1st shots of the Pfizer Covid-19 vaccine on 30Mar2021. A couple of weeks before, he had a heart attack on 10Mar2021 and received 2 stents. He had another stent put in today, 19Apr2021. He is scheduled for his 2nd shot on 21Apr2021 on Wednesday. She doesn't think he can go. He might be able to go by Friday or Monday. She reports that her husband did not feel any side effects however she got swollen under her arm. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
on 8/23/22 mom noticed rendess/swelling at injection site, gave benadryl and monitored, on 8/29/22 was seen in office due to worsening swelling/oozing at injection site, diagnosed with impetigo and give rx for augmentin, had f/u appt on 9/9/22 with improving infection
Vaccinator attempted to give vaccine using vanish point needle. Needle misfired and retracted when vaccinator attempted to administer. Some vaccine was injected, but some also squirted on the arm of the pt. Per CDC guidance, another vaccine of standard dose was administered in the patient's other arm.
Patient said she had some soreness immediately after receiving the vaccine, and that it has lasted since then.  She said the pain has gotten worse and she has trouble with daily tasks, such as putting clothes on. She was seen by her primary care provider and diagnosed with SIRVA.  Soon she is going to see a specialist, and may possibly receive therapy for this.
it is all swollen; it is all red; injection site itches like crazy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itches like crazy), VACCINATION SITE SWELLING (it is all swollen) and VACCINATION SITE ERYTHEMA (it is all red) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itches like crazy). On 15-Apr-2021, the patient experienced VACCINATION SITE SWELLING (it is all swollen) and VACCINATION SITE ERYTHEMA (it is all red). At the time of the report, VACCINATION SITE PRURITUS (injection site itches like crazy), VACCINATION SITE SWELLING (it is all swollen) and VACCINATION SITE ERYTHEMA (it is all red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Mom noted rash erupted 5 days, post vax. Dx'd with shingles on left upper thigh, buttock and around midline labia. Pt had pain and itching. On 8/18/00, Augmentin was started. on 8/22/00, Zovirax ointment and Bactrim. Still itching and pain.
48 y/o c/o feeling light headed w/ left arm tingling within a few minutes of receiving second vaccine dose.  Pt states she feels anxious and " unexplainable" ? Feels like heart is racing.States there are too many people in here.  Denies CP NO SOB  Pmhx - Unremarkable  Meds- None   VS : 136/87  HR: 87  RR : 17  Pt A & O x 3  Appears visibly anxious, jittery, speech coherent but speaks fast   Plan: Transfer to ED - symptoms resolved on arrival to ED, patient goes home
Shortness of breath, enlarged heart, thrombus in my left ventricle, low ejection fracture, congestion heart failure, cardiomyopathy.  Wore life vest for four month and finally had to get a internal cardiac defibrillator on June 3, 2022.  I have been on a heart failure protocol of medication since the end of January 2022.
Extreme inflammation (swelling, hot to the touch, rash) at injection site and extending four inches below the site.
Patient received COVID-19 vaccine booster in his long term care residence in the SCI unit at Medical Center on 10/26. On 10/27 he was transferred to the ER for fevers, chills, injection site warmth/erythema and afib w/ RVR. Also with increased SOB which improved with suctioning. He was admitted to ICU and started on empiric antibiotics for c/f infection. Infectious workup negative and so antibiotics were discontinued on 10/30, symptoms were deemed more likely vaccine adverse effect. Transferred back to the SCI unit on 10/31.
Initially a sore arm and  headache starting around 11 am the day after receiving the vaccine, I started feeling cold. By 1 pm, I couldn't get warm.  I took Tylenol at 3 pm My husband took my temperature sometime between 3 and 4:30 and it was 99.3 Sometime late in the afternoon, early evening, my husband had me measure my oxygen level and it was 91% We monitored both my temperature and oxygen levels the rest of the evening. My temperature was down to 98.1 by 5 pm and has not been elevated since. My oxygen level returned to around 95% by 10 pm.  When measured this morning, my oxygen level was 95 to 98%.
woke at 3:30 with severe nausea, vomiting followed, fever, body aches, exhaustion, injection site pain, diarreaha, slept most of the following day....on day two (evening) following shot, arm swelled in a big ball shape at injection site, big red rash, and hot to touch....this laster for 3.5 days, is largely resolved as of this morning
This spontaneous report received from a medical assistant referred to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. The medical assistant reported that unspecified patients were administered improperly stored vaccines ROTATEQ (lot: M007298; expiry date: 19-NOV-2017) on an unspecified date. No adverse effects were reported. The vaccine was stored at 35.52F for 8 hours and 2 minutes. There was no previous temperature excursion and the call was because of digital data logger. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA008775: same reporter US-009507513-1612USA008776: same reporter US-009507513-1612USA009010: same reporter.
7MAR dropfoot of rt foot; wk prior to that had numbness which resulted in tripping & falling-numbness extends from knee distally started pt 10MAr; wore brace, still wearing brace; 7APR numbness diminishing 7APR;
a nodule 0.5 x 1.5cm lt thigh;abscess? noticed 48hr p/shot
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 22-DEC-2014, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had two temperature excursions: 24 and 48 hours respectively. The lowest recorded temperature was 34 (1.111111111 Celsius degrees). The highest recorded temperature was 47 (8.333333333 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
First dose > 35 days ago; This case was received via the regulatory authority (Reference number: 126590) on 04-Aug-2021 and was forwarded to the company on 04-Aug-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose > 35 days ago) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, 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 experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose > 35 days ago). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose > 35 days ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
big red spots; rash all over his back and his sides and front, from back to shoulder; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over his back and his sides and front, from back to shoulder) and RASH (big red spots) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced RASH (rash all over his back and his sides and front, from back to shoulder). On an unknown date, the patient experienced RASH (big red spots). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (rash all over his back and his sides and front, from back to shoulder) and RASH (big red spots) outcome was unknown. Not Provided      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.
Work up with headache and chills, felt "fuzzy"  - not necessarily adverse event but side effect I guess you could call it.
sick; sore throat; Initial information received on 01-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who reported sick and sore throat while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event "sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date the patient developed a non-serious event "sore throat" (oropharyngeal pain) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (sick, sore throat).  At time of reporting, the outcome was Unknown for the event sick and was Unknown for the event sore throat.
I felt sick after receiving the second shot, I was told that was normal but there are long term effects that are have not gone away after 10 months.  Initially I just felt sick (headache, mild fever, fatigue, chest pain) and that all subsided after a day or two.  More concerning is that I was fairly athletic prior to the shot and have not been able to recover to my pre-shot abilities.  For example, prior to the shot I would run a 5K in about 23 minutes and have not been able to go any faster than 28 minutes since then, which is a struggle and is limited by my ability to breathe.  I realize that this is still decent for a 46 year old male but it represents a significant decrease in lung function.
Patient was administered COVID booster shot and high dose flu shot at 1528. At 1535, patient stated she felt like she was having a reaction. Patient reported she felt warm and her chest felt heavy, making it seem hard to take a breath. Patient's face, chest, and ears were red. Vitals were taken, see in chart. DNP was called to the conference room to evaluate patient. Patient remained in observation for 30 minutes, and voiced feeling better prior to leaving. Advised patient to report to the ER with any further concerns.
mom reported pt ha swollen rt leg-could not ben knee-area where shot was given was red, hot, swollen;t101 has been giving Motrin;told mom to apply ice or cool cloth;3JUL97 leg still swollen;
2 hrs after vaccination, not feeling well,  pt requested to be taken to ER. Per Spouse pt grabbing constantly to R side arm underneath armpit, pain. Pt discharged, next 2 days pt consistently sleeping  only 1 meal. Extreme tiredness and pain in R side underneath armpit continues. Per Spouse pt is "no where near alert as he used to be". Per Spouse pt fell to floor 1/19/2021 couldn't stand or walk, did not hit head or injury self. Spouse took pt to bed, pt has been in bed sleeping consistenly since then.
Maternal Exposure During Pregnancy, third trimester; Severe vertigo; This is a spontaneous report from a contactable consumer, the patient. A 35-years-old pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via an unspecified route of administration, in the right arm on 31Mar2021 at 16:45 (maternal exposure during pregnancy, third trimester) as a single dose for COVID-19 immunization (at the age of 35-years). The patient's medical history reported as none. Patient's concomitant medications were not reported. The last menstrual date of the patient was on 04Aug2020, gestation period was 34 weeks, and delivery date was on 09May2021. The patient had no known allergies. The patient received other vaccine within 4 weeks prior to the COVID vaccine which included tdap (tetanus-diphtheria- pertussis vaccine toxoid) (MANUFACTURER UNKNOWN) on 24Feb2021 for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in left arm on 10Mar2021 at 16:30 (at the age of 35-years-old) as a single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 03Apr2021, after 2.5 days of vaccination the patient experienced severe vertigo and it was ongoing and it was fourth day of vaccination at the time of report. On an unspecified date, she had maternal exposure during pregnancy, third trimester. No therapeutic measures were taken as a result of the reported events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event severe vertigo was not recovered, while outcome of another event was unknown.
The patient received their booster Moderna covid vaccine in clinic here on 1.26.22. Right arm was used. They indicated that they were on blood thinners and so pressure was applied to injection site post injection. Today the patient presented to clinic and complained of swelling and sore arm. They stated they had not contacted their primary physician and that the swelling had started the day after the shot.  On checking the arm there appeared a small bruise, mild swelling and firmness to the area. I advised the patient to contact their health care provider to see if they deemed any treatment besides those the patient had been doing ( cold compresses) and that I would complete a VAERS form.
Approx. 5 min after receiving vaccine; pt. stood up in order to put their jacket on. Had onset of light headedness followed by nausea. Symptoms subsided within 10 mins. Vital signs w/in normal limits for pt.
After receiving the vaccine I felt completely fine, just the regular sore arm. Two days later I thought I was getting bit  by mosquitos because I was experiencing hives, I even had to call the health department to take car of the mosquitos but that wasn't the case at all, because they were hives and not mosquito bites. I was also receiving heat flashes throughout the night and that is still going on until this day. I was prescribed Prednisone 20mg 3 times a day for four days by my PCP and I did not see any changes for the random hives that I was experiencing throughout the day. Another problem that I have been experiencing was being dizzy at random times as well. I was advised by my PCP to go to the dermatologist to receive an allergy test but haven't been able to get around too it.
This was the second injection. My reaction this time was MUCH more extreme than the first. It's now 2 days out and joints are much better, but still very stiff and sore?have tingling sensation in my right hand from elbow down. 1.  Joints became inflamed and swollen?the morning after I couldn't make fists with either hand due to pain and swelling. Knees, elbows, shoulders and neck all extremely inflamed, sore and stiff. Walking was difficult due to knee pain. 2.  Fever 3.  Headache 4.  Overall body aches and discomfort?flu-like symptoms on steroids
This spontaneous report as received from a Medical assistant refers to a female patient of unknown age. On 29-MAY-2015, the patient was vaccinated with an expired dose of MMR II (injection; lot#J006185; exp date: 24-MAY-2015) (dose and route not reported). No adverse effects reported. No PQC involved. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a adult female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, several hours after receiving SHINGRIX, the patient experienced injected limb mobility decreased, pain in arm and activities of daily living impaired. On an unknown date, the patient experienced injection site bruising. On an unknown date, the outcome of the injected limb mobility decreased, injection site bruising and activities of daily living impaired were recovered/resolved and the outcome of the pain in arm was recovering/resolving. It was unknown if the reporter considered the injected limb mobility decreased, injection site bruising, pain in arm and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left deltoid. The patient was unable to give the exact date and time, but the date was towards the end of June 2018, in the afternoon. The patient reported that after receiving the injection, she felt fine but later that same evening, her left arm became very sore to a point where you could not lift her arm, Her husband had to assist her with dressing and undressing over the next few days and she had to use her right arm to lift her left arm when she was at work. She also had difficulty showering and could not use her left arm for several days. She reported she was able to at least move her left arm after several days, but the left arm remained very sore over the course of several weeks and did have a small bruise at the injection site. The patient reported she did notify her physician about the symptoms and he was not concerned. The patient was scheduled to have her next injection in September which was scheduled in her doctor's office along with receiving a Hepatitis B vaccine. She was concerned she would have to go through similar arm pain with the second injection.
Received immunizations 02/22/2005, DTAP in left deltoid.  In late afternoon of 02/23/2005 the left arm in deltoid area of upper arm began to redden, swell, and feel hot and painful to child.  Warm to touch.  Mother brought child back to hospital on 02/24/2005 - Observed arm and referal to care at clinic in same building by physician.