chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient came back in the office at a later date and did not report having any side effects; The patient was in the office to receive the Meningitis Vaccine, Manectra, but the MMR II was administered instead; She states the patient had already received all his childhood MMR II doses; This spontaneous report has been received from an office manager concerning a 17 year old male patient. The patient's concomitant therapies, concurrent conditions, historical drugs and medical history were not reported.      On 17-AUG-2020, the patient was inadvertently  vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA) (dosage regimen was not provided)  Lot # S032036, expiration date 10-OCT-2021 for prophylaxis.        The patient was in the office to receive the meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA), but the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)  was administered instead. The reporter stated this error was due to product confusion because the meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) vaccine and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) were next to each other in the fridge. The fridge was organized in alphabetical order.  Further details about the product confusion were not reported.  On an unknown date (reported as ¨at a later date¨), the patient came back in the office  and did not report having any side effects. The reporter confirmed,  the patient had already received all his childhood measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses.
- Within a few days after my 1st shot, I felt a soreness in my arm shot and fatigue, which disappeared after then. - 10 days after my 1st shot (today), I woke up at 4am with a really bad fever, with fatigue/weakness/body aches to follow later in the morning. I took Advil to reduce my fever,  which lowered my temperatures.... but I still have a headache and feel light headed.
A spontaneous report received from consumer. The report concerns a 13 years 21 weeks 1 day old, male patient, (height : 68.0 inches, weight: 140.0 pounds). The patient's relevant history included hospitalization. The patient's concurrent diseases included arm swelling after flu shot. Concomitant medications included salbutamol for respiratory wheeze and fluticasone propionate for inflammation in lungs post infection. Patient received FLUMIST (intranasal) 0.2 ml in 2012, 2013, and 2014. Also prescribed oral PRILOSEC Rx capsule unknown dose and frequency, started 18-Jan-2015. Unknown stop but he took the PRILOSEC Rx for about 3-4 months. The reporter thought patient may have taken Omeprazole Rx  for about 1 month sometime after 18-Jan-2015 for stomach pain. He also took Omeprazole OTC for 2-3 months sometime after taking PRILOSEC Rx. The reporter stated the patient may have switched from PRILOSEC Rx to Omeprazole Rx to Omeprazole OTC based on availability. Specified dates are not known. It was reported that patient used PRILOSEC Rx for long term and FLUMIST QUADRIVALENT did not work still got influenza B, hospitalized 5-Jan-2015 to 18-Jan-2015 ICU and was intubated on 07-Jan-2015 and had bad stomach issues after intubation, was throwing up and gagging on tube, after extubation anything he would eat would throw up it was painful to eat, swallow, or drink, had stomach pain. ZANTAC was not working was still having stomach pain after discharge from hospital. Esophagus was burning had reflux and stomach was burning, septic with low blood pressure, pneumonia, blood clot and attributes to a cast that was placed after x ray showed bilateral tibia fracture but left leg fracture was worse and was casted, leg cast placed for fracture 12-Aug-2015, weight loss 20 lb with continued complications with stress fractures and residual complications from being sick from the flu. Complaining of leg pain and was walking around on stress fractures and this was treated with shin splints. The reporter assumed that the patient had loss of bone density. The outcome of influenza B/flu, septic, stomach issues, throwing up, stomach pain, esophagus was burning/stomach was burning, pneumonia, blood clot in leg, weight loss, complaining of leg pain, gagging, painful to eat, swallow and drink, reflux, stress fractures, sick, flu, bilateral tibia fracture, loss of bone density, long term use PRILOSEC Rx and FLUMIST QUADRIVALENT did not work was unknown. The event loss of bone density was identified by the company physician from the source documents and added as adverse event and considered it serious due to the important medical event. The company physician assessed the septic, stress fractures and bilateral tibia fracture to be serious due to important medical event. The company physician assessed the FLUMIST QUADRIVALENT did not work, influenza B/flu to be serious due to hospitalization and rest all events were assessed as non-serious.
Patient reports that after receiving FLUZONE HD that side's neck and face swelled for several days. Also she experienced nausea and headache.
Spontaneous bruising started 4 days after MMR.  Patient seen in office for bruising on 5/2/08.  Platelets were 7000 treated with 1 T.P.
no adverse event, dose given 1 day per calendar days early, during the six months there are 4 months with 31 days and 1 month 28 days, technically given 2 days post 6 months if you are counting actual days.
PATIENT HAD ONLY MILD BODY ACHE AND HEADACHE THE FIRST DAY, THEN NEXT DAY SHE STRATED TO HAVE RASHES ON HER CHEAST, BACK AND ARMS AND ON HER THIRD DAY AFTER THE VACCINE SHE STARTED TO FEEL LIKE SEVERE TINGLING SENSATION AND NEEDLE STICK LIKE ON HER ARMS AND FEET SHE TOOK BENADRYL AND STARTED TO FEEL BETTER
5 hours after shot had fever/chills/shaking/fast heartbeat for 4-5 hours. Did not go to doctor's office. Pt was fine by the morning except for being tired.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 02-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route unspecified) and then received another dose of ZOSTAVAX (lot#, expiration date, dose and route unspecified) on 02-DEC-2014. No adverse effects reported. Additional information has been requested.
I started feeling sick and called my doctor. I tested for COVID-19 at home and the results came back positive. The doctor prescribed me with Paxlovid and I began feeling better between 24-36 hours after taking the medication.
This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. On 04-SEP-2013, the patient was vaccinated with a dose of ROTATEQ 2 ml (Lot # and expiration date not reported, oral. On 05-NOV-2013 the patient was vaccinated with a dose of ROTATEQ, oral (dose not reported) (lot # 0284AE; expiration date 25-OCT-2013). It was reported that the patient was administered and expired dose of ROTATEQ on 05-NOV-2013. At the time of the report patients outcome was unknown. Additional information has been requested.
heavy menstruation; fibroids; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete; Unknown Manufacturer), for COVID-19 immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "not recovered", described as "heavy menstruation"; UTERINE LEIOMYOMA (non-serious), outcome "not recovered", described as "fibroids". The event "heavy menstruation" required emergency room visit.  Additional information: The patient suffered from fibroids and heavy menstrual cycles. The last time she took the booster (Nov2021). Her period was so heavy that she almost had to go to the ER. Super plus tampon every 30-40 minutes for two 48 hours. This happened for two months. For this reason, she could not take the new booster due to excessive bleeding.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a consumer and described the occurrence of chronic diarrhea in a 41-year-old female subject who was vaccinated with ENGERIX B. A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to gluten. Concurrent medications included PRILOSEC and MOTRIN. On 10 December 2008 at 10:00 the subject received 1st dose of ENGERIX B (unknown, left arm). On 10 December 2008, 4 hours after vaccination with ENGERIX B, the subject experienced chronic diarrhea. The subject developed chronic diarrhea four hours after receiving the ENGERIX B vaccine, which is still ongoing. The reported believed it is related to the yeast in the vaccine because the subject has a gluten allergy. At the time of reporting the event was unresolved.
Around the morning of 12/23/2022, I had a cough and cold like symptoms. It got continuously worse, and I had a lot of fatigue. I wound up sick in bed, which is unusual for me. The coughing was incredibly painful. It went on for about a week or a little bit longer. At one point, I tried to get out of bed, and I was so weak, that I couldn't stand up. After I had been through all of this, my body was really sore from all of the coughing. After all of that, I wound up going to the doctor. He said that it was COVID-19. He prescribed me some antibiotics. It took a week to 10 days for the cough to go away. The fatigue took a week or two to go away. I lost around 25 or 26 pounds because I wasn't eating. Eventually, I got my energy back and was able to eat again slowly. It was a few weeks before I could eat again. I did drink a lot of fluids during that time. The antibiotics seemed to knock out the cough and cold like symptoms. It was all over a course of 10 days to 2 weeks.
swelling, erythema of upper arm where shot given, some mild tenderness, lasting several days;
Severe fatigue; Muscle aches, body aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Severe fatigue) and MYALGIA (Muscle aches, body aches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D NOS for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced FATIGUE (Severe fatigue) and MYALGIA (Muscle aches, body aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 15-Mar-2021, FATIGUE (Severe fatigue) and MYALGIA (Muscle aches, body aches) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.
This spontaneous report as received from a nurse refers to a 22 months 11 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
LOCALIZED REDNESS, SORE, HARDENED AREA. ROUND, ORANGE SIZE. HAD FIRST VZV ON 6/27/99, #2 ON 7/15/99, CAIR INDICATED THAT #2 WAS STILL DUE. GIVEN ON 3/1/15.
expired Moderna vaccine was given to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine was given to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine was given to patients). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine was given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment details were not given.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 29th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced fever, muscle pain, injection site pain and tiredness. On an unknown date, the outcome of the fever, muscle pain, injection site pain and tiredness were unknown.  It was unknown if the reporter considered the fever, muscle pain, injection site pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient felt great prior to the shot on 29th January 2019 at 3 PM. The patient experienced side effects described as fever (body temperature 102 degree F), muscle aches and pain at injection site. The patient also had extreme tiredness. The patient stated that, the injection site was sore but there was no swelling or rash. The patient asked if these were normal reactions. A nurse at clinic said, these reactions were rare.
Its painful when she moves; Burning pain in that area; sharp pain on the injection site arm./not very close to injection site/repeatedly was progressing worse/it has significant burning pain; If she turns her head, there is pain in her shoulder; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Its painful when she moves), BURNING SENSATION (Burning pain in that area), VACCINATION SITE PAIN (sharp pain on the injection site arm./not very close to injection site/repeatedly was progressing worse/it has significant burning pain) and ARTHRALGIA (If she turns her head, there is pain in her shoulder) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Its painful when she moves), BURNING SENSATION (Burning pain in that area), VACCINATION SITE PAIN (sharp pain on the injection site arm./not very close to injection site/repeatedly was progressing worse/it has significant burning pain) and ARTHRALGIA (If she turns her head, there is pain in her shoulder). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Its painful when she moves), BURNING SENSATION (Burning pain in that area), VACCINATION SITE PAIN (sharp pain on the injection site arm./not very close to injection site/repeatedly was progressing worse/it has significant burning pain) and ARTHRALGIA (If she turns her head, there is pain in her shoulder) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
1330 EMPLOYEE RECEIVED THE COVID VACCINE. EMPLOYEE SAT IN EMPLOYEE HEALTH OFFICE FOR APPROX 15 MINUTES AFTER INJECTION. EMPLOYEE RETURNED WITHIN 5 MINUTES OF LEAVING AND STATED SHE WAS SHAKING AND HAD A SEVERE HEADACHE. EMPLOYEE WAS ESCORTED OUT TO ER AND WAS SEEN BY A PROVIDER. EMPLOYEE WAS GIVEN IBUPROFEN AND DISCHARGED FROM THE ER WITH A DIAGNOSIS OF HEADACHE-UNSPECIFIED. EMPLOYEE RETURNED BACK TO WORK.
Information was received on 04-FEB-2019 from a lawyer and an approximately 67 year old  male consumer regarding a case in litigation. In 2015 the patient was administered the ZOSTAVAX (lot number and expiration not reported) by a pharmacist for the long term prevention of shingles and zoster related conditions. Later in 2015 the patient was treated by a physician for the following injuries resulting from use of ZOSTAVAX: shingles. Outcome of shingles was unknown. Additional information has been requested.
This initial spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions reported. The reporter stated that since 08-JUN-2015, the patients were administered with an unspecified number of improperly stored doses of GARDASIL 9 injection (lot #L006547 with expiration date 04-MAR-2017, Lot# L014415 with expiration date 25-JUL-2017 and Lot# K026246 with expiration date 28-JAN-2017; strength, dose and route were not provided). There was no concomitant medication. It was unknown if the patients sought medical attention. Product quality complaint was not involved. No adverse experiences were reported. This is one of several reports received from the same reporter. Lot number L014415 has been verified to be valid lot number for GARDASIL 9. Additional information has been requested.
"After staff member received their second dose stated complaining of dizziness and hot flashes, feeling warm in the abdomen area. Elevate staff members feet. Monitored blood pressure. Vital signs:  0755 127/85 HR 80 Ox 99. 0800 127/86 HR 72 Ox 99. 0805 133/87 HR 69 Ox 100. After 30 mins the staff member sates she is feeling better and well enough to head home. "
Hip and knee pain bilaterally, eventually unable to walk, admitted to hospital.  Work up negative except for bilateral hip effusions on MRI.  Likely transient synovitis, no evidence of septic joint.  Improved with physical therapy and naproxen. 12/1/2009 PCP records for 11/8, 11/12/2009. and 11/14/2009. Patient initially presented on 11/8/2009 with c/o's rt knee pain and fever this progressed to bilateral knee pain and swelling on 11/12/2009. Xrays and labs were wnl, rx'd Naprosyn,  returned on 11/14/2009 with c/o's lt hip and thigh pain, rx'd tylenol w/codeine 12/2, 3 and 12/4/2009 MR and DC summary for 11/15-11/19/2009 patient admitted with migratory joint pain, labs and dx studies failed to reveal any cause, Tx: pain meds and PT, dc'd with home PT 12/7/2009 Dc summary for 11/15/2009, patient trasferred to another facility for inpatient stay. Dx: polyarthritis. 12/4/09 Medical records received for DOS 11/16/09. Final DX: Polyarthritis, arthritis of multiple joints Persistent joint pain. Worse R side. Sever w/external internal rotation. Cannot ambulate due to pain. Too painful to be carried. Joint swelling decreased. Neuro PE WNL. Fourth visit in one week for this issue. Possible secondary gain. CBC WNL.  ICD9: 716.99
This is a spontaneous report from a contactable consumer (The patient). A 51-year-old female The patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6206), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 14:00 (at the age of 51-year) as 1st dose, single dose for COVID-19 immunization. Medical history included ongoing asthma, ADD and vitamin d deficiency from an unknown date and unknown if ongoing. The patient had Bee stings allergy from an unknown date and unknown if ongoing. Concomitant medication(s) included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Facility where vaccine was administered was Hospital. On 05Mar2021 at 14:15, the patient experienced constriction feeling in throat and cough. The patient stated within 30 min of injection constriction feeling in throat, cough within 1 hour, asthma events x 3 within 2 days (throat spasms cause coughing fits). Symptoms decreased with use of inhaler. Still experiencing some mild asthma symptoms 3 days after injection. The patient visited doctor or other healthcare professional office/clinic for adverse events. The patient received Ventolin inhaler (at home) as treatment for adverse event. Therapeutic measures were taken as a result of constriction feeling in throat and cough. The outcome of events was recovering.    No follow-up attempts are possible. No further information is expected.
Woke up and had a charley horse around the injection site. It wasn't swollen, puffy, wasn't hot to the touch. I tried to rub it out like you would do a charley horse and it just stop at about 9 am on its own. Around noon it just faired like a severe charley horse again and my entire arm seized up. The pain was a 8 on a standard (1-10) scale. When I called the doctor they were at a lost and told me to try heat and ice. I tried heat and ice and it did not help. I also tried CBD cream and it didn't help. One second to the next it was there then it was gone. For a total of two weeks it would do this 2/3 times a day it would be there and the next second it's gone. After the two weeks it traveled to my calf and then all over my body. My right leg hurt so bad like a charley horse and it would last 15-20 min and then it would just stop. This continued until mid Oct. It completely went away.