chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the 5/17/2021 , Monday, at  about 11.00am the patient came to the pharmacy to report adverse reaction to the administered moderna vaccine that was given on 05/08/2021. She  had a swollen arm that was tender at the injection site. She also complained of aches,pain,headache,fever and rash. I  calmed her and advised to take otc  Ibuprofen ( for pain and inflammation) and  Benadryl  ( antihistamine ) to reduce pain ,inflammation and the  allergic reaction
Patient received a second dose of bivalent Moderna when they were up to date at the time per responses on vaccine screening questionnaire.
Pt received dose on 08APR2021 @ 1200. Pt had adverse reaction at 1300. Pt states she felt tightness in jaw which still continues to 16APR2021, feeling unwell, and weakness in arms and legs starting on 16APR2021.
hives 3 hours after vaccine, shaking . hives were on my arms , legs, back and my tongue was tingling
He comes to the emergency room complaining of 2-3 days of right upper  quadrant abdominal pain with nausea, vomiting, diarrhea, cough, body aches.   He said he was immunized with COVID-19 in January and February of this year.   He lives with his wife and children, none of whom are sick.  He came to  emergency room with these complaints.  He tested positive for COVID-19.  Also,  his urinalysis was abnormal showing esterase 2+ and WBC 6-10.  CT abdomen and  pelvis is raising the possibility of acute cholecystitis for which the  surgeon was called and will see the patient in the morning.  Patient was  saturating anywhere between 92% to 94% at rest, but when we did the ABG, his  pO2 was only 66.% on room air.  So, the patient was also started on Decadron  and remdesivir.  For his UTI and his COVID-19 status, he is already started on  Zosyn. Admitted on 9/13/2021. Urine culture 09/13/21 E Coli . He had acute hypoxemic respiratory failure secondary to COVID 19 viral and suspected secondary bacteria pneumonia . Was on  decadron , remdesivir , supportive oxygenation , CXR showed right basilar subsegmental atelectasis. Upon discharge , patient was not using oxygen. Discharged on 9/18/21
Information has been received from a nurse concerning a 3-year-old patient who at approximately 12-15 months of age, approximately in 2005, was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). In August 2007, it was reported that "the patient is experiencing a severe breakthrough of chickenpox". On an unspecified date, the patient was seen at the doctor's office. The outcome was reported as recovering. No product quality complaint was involved. Additional information has been requested.
Body aches; Feverish, Temperature- 99.9; This is a spontaneous report received from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: P81301EP6955), via an unspecified route of administration on 24Mar2021 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included blood pressure (as reported). The patient did not have any allergies to medications, food, or other products. Concomitant medications included losartan (MANUFACTURER UNKNOWN) for unknown indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. On 25Mar2021, the patient experienced body aches and feverish with temperature of 99.9 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome for the events general body pain and fever was recovering.  No follow-up attempts are possible. No further information is expected.
Complaints of Joint Pain and full body aches for 48 hours+. She did not report adverse event until 8/28/2017.
Temp inc 103.4ax; No other s&s; 28FEB91 mom states temp normal, child active; 19MAR91 temp 104.5 - no sz or high pitched crying;
This case was reported by a physician via call center representative and described the occurrence of bullous pemphigoid in a 85-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included cataract. On 30th April 2018, the patient received the 1st dose of SHINGRIX. In May 2018, several weeks after receiving SHINGRX, the patient experienced bullous pemphigoid (serious criteria GSK medically significant) and rash. The patient was treated with steroids nos (Steroid Injection). On an unknown date, the outcome of the bullous pemphigoid and rash were not recovered/not resolved. It was unknown if the reporter considered the bullous pemphigoid and rash to be related to SHINGRIX. Additional details were provided as follows: The patient developed a rash a few days after receiving cataract surgery in May 2018 (several weeks after SHINGRIX). The patient saw a dermatologist and was given Steroid injection and rash got significantly better in mid-July 2018.  The patient then had second cataract surgery and rash seemed to get worse following the surgery. In 2018, rash was biopsied and diagnosed as bullous pemphigoid. The rash was bilateral and on torso, arms and legs. The lot number, expiration date, site of administration and route of administration of SHINGRIX were asked but were unknown to the reporter.
This spontaneous report as received from a female pharmacist of unknown age refers to herself. On an approximately 20-NOV-2014 reported as about two weeks ago the pharmacist was administering a dose of ZOSTAVAX (dose, route and lot number were not reported) to patient but during administration approximately on 20-NOV-2014 some of the ZOSTAVAX got on her hand. The pharmacist reported that on 01-DEC-2014 she developed a shingles like rash and pain at the rash site. The pharmacist was seen by an unspecified physician on 04-DEC-2014, and was diagnosed with shingles. The pharmacist reported that her physician prescribed VALTREX and Lidocaine cream for treatment. The patient's outcome was not reported. The relatedness between ZOSTAVAX and the patient's events was not reported. This report is one of 2 reports from the same source. Additional information has been requested.
This spontaneous report as received from a health care worker (medical assistant) refers to ten unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, ten unspecified patients were vaccinated with GARDASIL (dose, route and lot number were not provided. On an unknown date, GARDASIL were exposed to temperatures outside of the proper storage range and no adverse effect was reported. Additional information has been requested.
About 3hours after shot, I started having breathing problems, like an asthma attack. I used my ProAir Respiclick once an hour for about the next 6-8 hours. I used it several times during the night and continued to use it about 4-6 times a day for the next 3 days. I still seem to have a hard time breathing a few times a day.  On top of that my knee that had January surgery in, started hurting so bad about the same time. I had to get my cain out and use it the next 4 days. The pain from surgery was almost gone before shot.
Hospitalized in ICU on vent, dialysis and sedation, angioedema and exacerbation of all underlying chronic disease states.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot # not provided). On an unknown date, other unspecified pharmacist had been removing ZOSTAVAX from the freezer and let the vaccine sit out on the counter for 5 minutes before reconstituting, so it could thaw a little before administration. No adverse effect were reported. Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 12:35 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 12:35 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) 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 40.01 Concomitant products were not provided.  On 13-FEB-2021, Excursion time was reported at 9:00 A.M  with  temperature as 32  degrees Fahrenheit, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-FEB-2021, vial was moved to clinic on  13-JAN-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-MAR-2021.  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 Fisherbrand 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 on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Painful period; Painful, heavy period beginning 3 days after first injection, extremely abnormal; Next 3 periods were also very heavy/menstrual flow was twice as heavy as it had been for the past 10 years; Horrible lower back pain 10 daysbefore menstruating began.; Pain; Discomfort; Symptoms was similar to adenomyosis; Abdomen feels bruised a few days before cycle begins and a few days after; Spotting before most recent period which was something that never occurs; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 17Feb2021 at 15:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, sleep apnea and penicillin allergy. The patient has taken unspecified concomitant medications. The patient previously took cephalosporin nos (MANUFACTURER UNKNOWN) and experienced allergy on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Feb2021 at 09:00, the patient experienced painful, heavy period beginning 3 days after first injection, extremely abnormal for her, the next 3 periods were also very heavy and resulted in horrible lower back pain 10 days before menstruating began, ultrasound showed no uterine abnormalities to indicate the pain and discomfort, symptoms was similar to adenomyosis and her abdomen felt bruised a few days before her cycle begins and a few days after and had spotting before her most recent period which was something that never occurs for her and her menstrual flow was twice as heavy as it had been for the past 10 years, none of this occurred for her until 3 days after her initial injection, now once a month she was in misery for 1/3 of it. Therapeutic measures were not taken as a result of these events. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events painful, heavy period beginning 3 days after first injection, extremely abnormal for her, the next 3 periods were also very heavy and resulted in horrible lower back pain 10 days before menstruating began, pain and discomfort, adenomyosis and her abdomen felt bruised a few days before her cycle begins and a few days after and had spotting, her menstrual flow was twice as heavy as it had been for the past 10 years was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Swollen supraclavicular lymph nodes on the left side of body, same side as injection. The lymph nodes are hard and painful to the touch. They appeared after the first shot but have grown in sensitivity after the 2nd shot. Fever, headache, fatigue and nausea are also apparent symptoms. Today I woke up with pain in my neck, like someone chopped me in the throat. It?s not a sore throat pain, but a hurts to swallow pain.
cancer; heart disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: unknown, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer"; CARDIAC DISORDER (medically significant), outcome "unknown", described as "heart disease". Clinical course: Withheld called in asking where to get a prescription Paxlovid or a list of doctors who's prescribing it. She also mentioned that she, her husband and son have all been vaccinated and boosted and that her husband has cancer and heart disease and her son has an autoimmune disease. She also said she managed to get Covid even after being vaccinated. The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a other medical assistant concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 04-FEB-2014 the patient was vaccinated with ROTATEQ (dose, strength and route were not reported) dose 1. Co-suspect and concomitant therapies were not reported. The medical assistant reported that on 04-FEB-2014, the patient received a dose 1 of ROTATEQ (that was improperly stored). No adverse effects reported. These case is linked to MARRS # 1402USA005231 by the same reporter. Additional information has been requested.
Metallic taste in mouth about an hour after receiving the vaccine - lasted about 5 hours.  Body Aches, Fatigue all over starting 24 hours after receiving vaccine.  Lasted for about 8 hours. Fully recovered by next morning.
Headache; fever; When I walk I get tired; Fell bad; Feel weak; Can't breath / when I walk fight to be able to breath; Flu; Cough; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Fell bad), ASTHENIA (Feel weak), DYSPNOEA (Can't breath / when I walk fight to be able to breath), INFLUENZA LIKE ILLNESS (Flu) and COUGH (Cough) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 28A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included Blood pressure pill and Cholesterol pill for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced FEELING ABNORMAL (Fell bad), ASTHENIA (Feel weak), DYSPNOEA (Can't breath / when I walk fight to be able to breath), INFLUENZA LIKE ILLNESS (Flu), COUGH (Cough), DIARRHOEA (Diarrhea), PYREXIA (fever) and FATIGUE (When I walk I get tired). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Fell bad), ASTHENIA (Feel weak), DYSPNOEA (Can't breath / when I walk fight to be able to breath), INFLUENZA LIKE ILLNESS (Flu), COUGH (Cough), DIARRHOEA (Diarrhea), PYREXIA (fever) and FATIGUE (When I walk I get tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-103859 (Patient Link).
About 3 hours after receiving the vaccination for Shingles, my arm starting hurting, very sore, difficult to move. Could not sleep well due to pain. Next day, felt fluish, arm from shoulder to elbow was red, warm, swollen and hurt to touch or move.  Took aspirin, tried to sleep. Day 2.5 now and it's still sore but better.  I"m still very weary, feel somewhat fluish.
Cried continuously off & on x 3 days; vomitting/diarrhea x 3 days;
pt arm became itchy, red, & swollen, area swollen & sore was approx egg size & warm to touch, went to ER 12:00;tx was taken DPH;pt refused because of large dose @ 745PM;DPH taken & heat applied to area for 3hr;
Shot given (PNEUMOVAX) 10/7/14. On 10/8/14 client calls complaining of swollen, hot upper arm. Patient told to see primary MD. MD prescribed KEFLEX, wants to perform MRI to rule out blood clot.
After receiving the vaccine I had soreness in my left arm. I developed a severe urinary tract infection the next day. I had severe heavy bleeding in the urine and severe left sided pain in the back. A week later I started to feel some aching under my left under arm and left breast. I had a mammogram on May 5th and I still had pain under my left breast area. A few weeks after getting the shot, the aching continued until early May. I had a headache the first day.
Hib  Conjugate Vaccine was mixed with "Sterile Diluent For Merck" instead of "Sterile Saline Diluent (0.9% NaCl), which is provided with the vaccine. After speaking with GSK, they offered no advice other than it is the provider's choice to re-administer vaccine or not, because the HIB has never been tested with any other diluent.
Pt came to clinic c/o reaction to pneumonia vaccine pt received yesterday. Arm is red from shoulder down to hand, pt c/o itching, swelling and soreness. Pt injection site is clear. Pt has taken BENADRYL twice. Pt given IM 40 mg DEPO-MEDROL/ 4mg DECADRON to rt hip/per vo Dr. Pt tol well. Pt instructed to take BENADRYL every 6 hrs. Pt voiced understanding. Treatment Drugs Used: Diphenhydramine Dose: 25 units: MG Freq: BID Route: PO Dexamethasone Dose: 4 units: MG Freq: ONCE Route: PO.
6 days of extreme nausea. Slowly got better after 6 days.  (Reporting on this because she reacted more severely to Dose 2).
May 29, 2003 - lg area of redness (11cm x10cm), swelling, warm, itchy, skin tight on left deltoid. Area not tender to touch.  No fever.  Recommended warm compresses, Motrin & Benadyl.
After 4month vomited several times, fever 102, very irritable. 6 month - no reactions, DT only.
Aches, headaches within 24 hrs. 14 days after, nausea, headache, vomiting, leg and arm numbness
third dose of Hiberix and accidentally received a dose of Vaxelis; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 6-month-old male patient who received Hib (Hiberix) (batch number 4SM94, expiry date 18-APR-2024) for prophylaxis.   Co-suspect products included VAXELIS VACCINE for prophylaxis.   On 22-MAY-2023, the patient received the 3rd dose of Hiberix (left thigh) .5 ml and VAXELIS VACCINE .5 ml. On 22-MAY-2023, an unknown time after receiving Hiberix, the patient experienced accidental overdose (Verbatim: third dose of Hiberix and accidentally received a dose of Vaxelis). The outcome of the accidental overdose was unknown.   Additional Information: GSK Receipt Date:23-MAY-2023 The reporter was the medical assistant of practice who states a male patient was given third dose of Hiberix and accidentally received a dose of Vaxelis (non GSK vaccine that contains Haemophilus b) the same day, which led to accidental overdose for Haemophilus b antigen. Adverse Event had been filed. The reporter consented to follow up.
I felt very bad a week after vaccine. I had flu like symptoms and was in the bed for 2-3 days. I felt fatigued from that point on. Approximately 2 months later, I got COVID with a positive COVID-19 test on January 11, 2022. I had extreme exhaustion and was in the bed for 1 week. My breathing was worse so I went to the doctor and was put on Prednisone. Two weeks later, I had a negative COVID-19 test on January 25, 2022.
PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 18-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498: