chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous prospective pregnancy report has been received from a 29 year old female healthcare student, for VARIVAX (Merck), a Pregnancy Registry product, concerning herself with no drug reactions or allergies. It was reported that in approximately 2013 (reported as "over 3 months ago") she was taking metformin and letrozole to help assist with becoming pregnant due to having polycystic ovarian disease but reported that the medications were stopped in approximately June 2013 (reported as "3 months ago"). On 20-JUN-2013 the patient was vaccinated subcutaneously with the first 0.5 ml dose of VARIVAX (Merck) (lot # was not reported). On 25-JUL-2013 the patient was vaccinated subcutaneously with the second 0.5 ml dose of VARIVAX (Merck) (lot # was not reported). The reason she received the VARIVAX (Merck) was due to titers being drawn before starting stool and the titers showed that she was not immune to varicella. There was no concomitant medication. It was reported the patient was currently 9 weeks pregnant. The patient became pregnant with LMP of approximately 22-JUL-2013 and EDD of approximately 28-APR-2014. At the time of reporting, the patient was at first trimester of exposure. No treatment was given for the event. The patient was seen by an unspecified endocrinologist on approximately 16-SEP-2013 (reported as"about a week ago"). At the time of report, the outcome of the pregnancy was unknown. Additional information is not expected.
Aching body muscles and joints.  Right knee joint is the worse. Symptoms have improved. Except for right knee pain.
7 days  after vaccination I had extreme vomiting, diarrhea, nausea, dehydration, dizziness, fever, chills, and a rash around vaccine site
Initial and follow-up information has been received from the Pregnancy Registry via a registered nurse concerning an 19 year old white female with bipolar disorder who on 05-DEC-2006 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (Lot #653736/0868F).  On 05-FEB-2007, the patient was vaccinated intramuscularly with a 0.5 ml second dose of Gardasil (Lot #655617/1447F).  There was no concomitant medication.  Subsequently, the patient was pregnant.  Her last menstrual period was on 05-MAR-2007 and the estimated date of delivery was 10-DEC-2007.  On 17-MAY-2007, and ultrasound was performed for bleeding and was found to be normal.  The patient had an office visit.  At the time of the report the patient's outcome was unknown.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/15/2008. Initial and follow-up information has been received from the Merck Pregnancy Registry via a registered nurse concerning an 19 year old female with bipolar disorder who on 05-DEC-2006 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (Lot #653736/0868F). On 05-FEB-2007 the patient was vaccinated intramuscularly with a 0.5 ml second dose of GARDASIL (Lot #655617/1447F). There was no concomitant medication. Subsequently the patient was pregnant. Her last menstrual period was on 05-MAR-2007 and the estimated date of delivery was 10-DEC-2007. On 17-MAY-2007 an ultrasound was performed for bleeding and was found to be normal. The patient had an office visit. At the time of the report the patient's outcome was unknown. Follow-up information was received from the registered nurse. The patient had a healthy baby girl on 20-DEC-2007 weighing 8 pounds 7 ounces the length of the baby was 30 inches and the apgar score was 6/9. The patient was 41 wees from LMP. Pre-eclampsia complication was seen during the pregnancy. The baby had shoulder dystocia. On 26-JUL-2007 the patient had an ultrasound and was normal. Additional information is not expected.
This spontaneous report as received from a physician refers to a 5 years old male patient. The patient was vaccinated with ZOSTAVAX (lot number not reported) on 23-OCT-2012. No concomitant medications were reported. The patient received a dose of ZOSTAVAX on 23-OCT-2012 instead of his second dose of VARIVAX (Merck). The patient received his first dose of VARIVAX (Merck) (lot number not reported) in March 2008. No adverse symptoms reported. Additional information has been requested.
This spontaneous report as received from a physician refers to a 14-year-old female patient. The patient's concurrent conditions included asthma exercise induced, allergic rhinitis, eczema and Raynaud's phenomenon. The patient had no drug reactions and no allergies. On an unknown date in June 2016 (reported as "sometime in June, 2016"), the patient was vaccinated with GARDASIL 9 (dose, lot #, expiration date and route of administration were not reported). Concomitant therapies included albuterol NASACORT. On an unknown date in June 2016, within hours after vaccination, the patient developed severe urticarial, over most of her body. She received an unspecified treatment and the hives subsided within one day. The outcome of the event was recovered on an unknown date in June 2016. The relatedness between the event and GARDASIL 9 was not provided. Additional information has been requested.
Severe muscle pain; Occasional chest pain, ER thinking a possible heart attack; Shortness of breath, ER thinking a possible heart attack; severe muscle pain in my left shoulder blade and arm down to; This case was reported by a consumer and described the occurrence of muscle pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included medication unknown (Blood Pressure Medication) and hmg coa reductase inhibitors (nos) (Statin (Unknown)).   On 5th January 2022, the patient received the 2nd dose of Shingrix. In January 2022, less than 3 weeks after receiving Shingrix, the patient experienced muscle pain, chest pain, shortness of breath and pain in arm. On an unknown date, the outcome of the muscle pain, chest pain, shortness of breath and pain in arm were recovered/resolved.   It was unknown if the reporter considered the muscle pain, chest pain, shortness of breath and pain in arm to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was unknown. The patient received a dose of Shingrix and experienced severe muscle pain in left shoulder blade and arm down to elbow and occasional chest pain and shortness of breath which lasted for more than 3 days after injection. The patient visited emergency room on 25th January 2022 for fear of experiencing possible heart attack symptoms. The patient underwent EKG (Electrocardiogram), chest X-rays and 2 rounds of blood work and several hours of heart monitoring. The patient was released as all tests showed normal activity and no signs of heart issues. The patient later read some comments on the website of the same symptoms by others months later. The patient was taking BP (Blood pressure),  medications and statin and not had any heart issues in past. The patient stated that the side effects on the information sheet should include these possible symptoms too which lasted for more than 3 days after injection. The patient expected to get paid the emergency room bill as a result of taking the vaccine. Consent to follow up was requested. This case has been linked to US2022AMR016128, reported by the same reporter, Hearsay case.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR016128:Same reporter. Hearsay case.
Erythemic, papular contiguous rash to torso & extremities. Excoriation noted, occurred 48 hrs post/vax. No localized reaction to injection site.
Hard swollen lump at the injection site.; Injection site itchy; Becomes red if barely rubbed; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the arm on 22Mar2021 at 13:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient previously received cephalexin and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), phentermine (MANUFACTURER UNKNOWN), vitamin b nos (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C) and biotin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient reported that she had no symptoms until one week from the first dose and her arm was not even sore. On 30Mar2021 at 20:00, the patient reported that she had a hard swollen lump at the injection site. It was itchy and became red if she barely rubbed it. No therapeutic measures were taken for any of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events hard swollen lump at the injection site, itchy injection site and red injection site were not resolved.  No follow-up attempts are needed; information about lot number cannot be obtained.
Developed shingles from administration of Zostavax. On June 21st saw primary care physician who diagnosed my condition as shingles.
Patient complained of tongue swelling and throat discomfort.  Received Benadryl and was transported to hospital for evaluation where she received steroids' and pepcid
I woke up with really extreme pain in my back stomach and my right shoulder so I went to the ER. I was told I had gallstones and was told to find a surgeon and ended up back in the hospital before then and was told I had a gallstone in my liver that caused Pancreatitis and waited for the inflammation to go down to remove my gallbladder which was removed 10MAR2023. I left the hospital 12MAR2023.
Patient c/o headache, fever 100.0, tiredness/fatigue and right shoulder pain near site.  No soreness or redness at site.  No congestion or sob.
I was at my physician's office for my annual physical and she noticed that my blood pressure was higher than normal. She did check it two more times before I left to see if it would come down, it did not come down. She prescribed a new blood pressure medication to add to my daily medication list. I was to take my blood pressure daily, input in online, come in every week for a while. It does appear my blood pressure has finally stabilized.
Mother reports child collapsed, became limp and did not respond, reports she was having trouble breathing, reports she had a seizure, febrile. Taken to medical center. Spoken with mother this morning reports child is febrile (100-101), crying continuously, sleeping, will take fluids, urinating decreased. Advised ER stat.
injection site was painful; shoulder muscle hurt; big artery y in back of my neck hurt; bowel movement was soft; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number and expiration date: not reported), via an unspecified route of administration on 14Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine includes took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number and expiration date: Not reported), via an unspecified route of administration on 20Feb2021 as dose 1, single for covid-19 immunization. It was reported that the injection site was painful, but patient's shoulder muscle hurt for the whole 3 weeks, the big artery y in back of neck hurt for 3 weeks too and it still hurts. For the whole 3 weeks bowel movement was soft. The outcome of the events was unknown.  Follow-up attempts were completed. No further information was expected.
restlessness during noc p/vax 23MAR93; began high pitched consistent crying approx 6AM on 24MAR & cont until 10PM on 24MAR; seen in ER x 2 on 24MAR approx 6AM & 6PM;
No additional adverse event reported.; Nurse reported a dose of expired VARlVAX (found supported) was given to a patient on 01/06/2021.; This spontaneous report was received from a nurse, referring to a 12-months-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 06-JAN-2021 (conflicting information also reported as "06-JAN-2020") , the patient was vaccinated with a expired dose (expired product administered) of varicella virus vaccine live (oka/merck) (VARIVAX), administered at a dose of 0.5 milliliter (ml), as prophylaxis (formulation, strength, vaccination scheme, anatomical site of vaccination and route of administration were not provided; lot number R034394, which has been verified to be valid, expiration date reported and validated as 27-NOV-2020). There was no previous temperature excursion reported. No additional adverse events were reported.
The patient is a 40-year-old female presenting for evaluation after receiving her moderna vaccine booster 2 days ago.  She states after receiving her booster she developed a headache and severe body aches.  She states now she is having nausea and vomiting and just cannot stop vomiting.  She had a couple episodes of diarrhea but this has resolved.  Last emesis was prior to arrival.  She denies any blood in her emesis or stool.  She states fevers are present and admits to chills.  Body aches did not improve with Tylenol or Motrin.  She has chest pain that sometimes occurs with coughing but is also present at rest. Patient has been taking her tramadol as well without improvement of her pain.  Patient states that she is able to keep down some fluids but cannot eat.  She denies any previous reactions to Covid vaccination.
This spontaneous report as received from a register nurse refers to unspecified number of patients of unknown age and gender. Since 26-JUL-2016, the patients were administered doses of oral, ROTATEQ lot numbers: K001716, expiration date 24-NOV-2016; K009753, expiration date 28-APR-2016; and lot number reported as K008144, expiration date 12-FEB-2016 (dose, strength and frequency were not reported), which were improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
After receiving my 1st dose I noticed that I developed a dry cough without mucus for 1 and half. I spoke with my doctor who changed my blood pressure medication 6-7 times within the years. She referred me to ENT. They checked and told me that everything was clear. I had nothing wrong. They even put a machine to check but found nothing wrong. Then I went to a Lung Specialist who told me my lungs were clear but I might have infection in my chest. He prescribed prednisone and promethazine. It helped with the cough for few days but after I finished the medication the dry cough came back. On the top of my breast bone is very painful. I can't even touch it. At this point nothing is ruled out. The cough is ongoing. It's bothering I can't sleep. I am getting worried. It is concerning. I will be going to a Gastroenterologist to see if they could rule out anything or where the cough is coming from.
Approximately 2 - 3 weeks after my booster shot I experienced the following; Abdominal throbbing pain (Lower right part) and some leg pain (both legs). I went to my primary doctor and he prescribed me with gas pills and Fiber that I include in my coffee in the morning. It did help and the pain went away.   As for the leg pain my doctor gave me some physical exercises that seemed to help but as of today it still comes and go every once in a while.
Pt received the 3 vaccinations and within 5 minutes began experiencing symptoms of vasovagal syncope. Pt proceeded to lie down on a floor mat while the local EMT's were dispatched to handle the situation from there. Pt seemed to continue to experience the symptoms about 15-20 min after they began and while she was take away in an ambulance to a local hospital for further evaluation.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # L002310, expiration date 08-JUL-2016 or lot # L012215, expiration date 13-JAN-2017 (doses and routes of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Heart Palpitations, still on going.  High fever Sweats Chills Shakes
This spontaneous report refers to an approximately 62 years old female patient who was also the reporter. Patient had pertinent medical history of high blood pressure. Drug allergy was reported as none. On 27-JAN-2014, the patient was vaccinated with ZOSTAVAX, injection, dose (unspecified), frequency (unspecified), in the arm. Concomitant therapies were reported as ALLEGRA and unspecified high blood pressure medication. On 27-JAN-2014, patients arm was sore and patient explained that in the arm she had the shot in she has had trouble moving and using the arm. Patient stated that the soreness lasted for a few days. On an unknown date in 2014, patient had begun to develop an increase in overall body achiness. The patient described the achiness as like having the flu but without the fever and cold symptoms, like she had aged 100 years overnight. The patient sought medical attention due to office visit. Patient explained that she was initially bedridden due to these symptoms. Patient initiated use with OTC ADVIL to help alleviate these symptoms, however due to the severity of the symptoms she asked her physician to increase her treatment to prescription strength IB Profin, 600mg. Patient also stated that this symptom had affected the quality of her sleep. Laboratory diagnostic studies performed were unspecified blood test and urine test. No product quality complaint was involved. The outcome of arm was sore was reported as recovered. Outcome of other events was reported as not recovered. Causality was not provided. On an unknown date in 2014 (around the time of vaccination), tuberculosis test was performed. Additional information has been requested.
Immediate tingling and numbness to left arm, hand and fingers on the side vaccine was given, followed by numbness/tingling that moved up neck and into left face lasting the rest of the day, palpitations starting same day affecting ability to sleep for several nights, palpitations continuing for approximately 8 weeks post injection, palpitations felt with exertion, unable to run at all after vaccine, normally I run 3x a week, unable to tolerate even as little as 30 seconds run/ jog without feeling SOB, lightheaded, palpitations, and extremely winded feeling, unable to tolerate lifting weights for 8 weeks after vaccine without palpitations.
COVID-19 virus infection; Diabetic ketoacidosis without coma associated with type 2 diabetes mellitus
Information has been received from a registered nurse concerning a 26 year old female with a yeast hypersensitivity, a history of yeast infections and rashes who on 11-AUG-2007 at 9:15am was vaccinated intramuscularly into the left deltoid with a first dose of Gardasil (658556/1060U).  There was no concomitant medication.  On 11-AUG-2007 at 9:20 am the patient felt dizzy and nauseated within minutes of the vaccination. The patient was placed in a reclining position and treated with 1 liter of oxygen nasal cannula. A cool, wet compress was placed on her forhead. Her blood pressure was 94/57. At 9:30 patient reported she was feeling better. Patient also reported that she had not eaten in the A.M. At 9:50 am patient was talking and feeling better. At 10:20 am patient was discharged to home and stated she was feeling well. Patient was instructed to call the office an Monday to report condition. On 11-AUG-2007 at 2:15 pm a call was placed to the patient. She reported not feeling well the rest of the day of vaccination and that on 12-AUG-2007 she recovered. Additional information has been requested.
Immediate pain in the arm after the injection and it still hurts 4 days later. Every arm movement causes pain. About 8 hours after the injection, I could feel my heart rate rising. I tried to sleep and experienced disturbed sleep. At 3:00 am I woke up and felt terrible. I checked my blood pressure, and it was normal at 105/61, but my heart rate was 99. My resting heart rate is typically  about 50. My heart rate doubling provided a terrible sensation. I could barely walk and shuffled around outside to get some fresh air. 3 hours later, my heart rate started coming back down but took a day to get back to normal. Even now, I have lost my appetite, am not eating much, and I just slept 16 hours. I have never experienced any vaccine such as this.
COVID related hospitalization after vaccination with Moderna vaccine series + booster (11/3/2021, 2/20/2021, 1/22/2021).  Moderna given 11/3/2021 left arm, lot 066F21A  2/20/2021 lot 006M20A   1/22/2021 lot 029L20A   Admitted 3/23/22  Discharged 3/26/22   Positive covid test 3/23/22  Presented with generalized fatigue, cough and shortness of breath for 7-8 days prior to admission.  Was treated outpatient with Levaquin 10-day therapy (suppose to finish in 2 days), but continued to have reduced oral intake and worsening fatigue and cough so came to hospital.   Chest X-ray with no acute abnormalities   On room air on admission 3/23/22. Overnight required oxygen and dexamethasone (Decadron) 6mg daily was started 3/24/22. Weaned back to room air in the afternoon on 3/24/22 but then required oxygen overnight.   Off of oxygen for 24hrs prior to discharge. Last dose of Decadron 3/26. No steroids after discharge.   Given guaifenesin 600mg for 7 days of therapy after discharge.
Exactly 7 days post injection, i developed a raised, red welt just below the injection site.  Borders were jagged and uneven.  It was originally thought by a doctor at the employee health clinic that it was a hive or histamine reaction to the injection.  A few hours after being seen, the area became extremely warm to the touch.  I took over the counter cetirizine, marked the margins and put a cold compress on the site.  The site has not spread outside the lines but remains warm to the touch.
Nausea and Vomiting over 2.5 hours Chills 2 hours Headache 3 days
TOOK TWO DOSES IN A ROW; This spontaneous case (PVX2019-1589) report was received from a consumer on 19-Jun-2019. It describes a 38-year-old female consumer who "took two doses in a row". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer took two doses in a row. The doses were taken on 18-Jun-2019 and 19-Jun-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
Premature atrial contractions lasting several weeks. Holter monitor confirmed. Then abated entirely.
My cheeks went numb instantly.  My arm hurt right away, but that is normal for  me.  Then I got extremely fatigued.  I waited the 30 minutes and went home.  Within two hours I had chills, low fever, shortness of breath, muscle and body aches, sore throat, congestion.  By the morning I still had all of the other symptoms but worse and I had no taste  or smell.  I had nausea and diarrhea along with all of the other symptoms.  I felt terrible for four days.  I remained very fatigued and my chest still feels heavy.