chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a male patient who on 11-JUL-2007 was vaccinated with .68cc of varicella virus vaccine live (Oka/Merck) (654754/1333F) instead of zoster vaccine live (Oka/Merck). No adverse experience and no symptoms were reported. The nurse mentioned that the event was not a case of product confusion and instead was a result of human error. No further information was available. No product quality complaint was involved. Additional information has been requested. Follow-up information received from a healthcare professional stated that when he went to grab the male patient's vaccine, he was rushing and didn't pay as much attention to it as he should have. The office kept both vaccines in the same freezer and he saw the varicella wording on the vaccine and grabbed the wrong one. The patient did not have an adverse event. The patient was in the office yesterday, on 23-AUG-2007 and received the zoster vaccine live (Oka/Merck).
Case number PHEH2012US008356 is an initial spontaneous report received from a physician on 17 Apr 2012. This case refers to a female child. The patient's medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: X10135B) intramuscularly on 21 Feb 2012. On the same day, she was also vaccinated with TDAP vaccine (batch number: unknown). Approximately one week after vaccination, she began to experience adverse visual effects. She was assessed to have near vision of 2200 and far vision of 20/20. The physician stated that the patient was being able to see but unable to read. The physician believed that this was an autoimmune reaction of the lens in both eyes. It was reported that they could not find anything on microscopic examination. The symptoms were continuing at the time of this report.
Noted soreness and swelling at injection site the day after receiving. Peak at day 5 with knot and pain at site. Seen in office on day 6 of symptoms - mild pink erythema, fullness but no warmth, pain or knot. No fever. Exam otherwise normal. Treat with ibuprofen and BENADRAL prn. Return if worsens or new symptoms.
16yr old patient was administered the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16yr old patient was administered the vaccine) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16yr old patient was administered the vaccine). On 30-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16yr old patient was administered the vaccine) had resolved. 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.   No relevant concomitant medications were reported.  Treatment information was not provided.
inadvertently vaccinated an elderly gentleman that had just been vaccinated; A spontaneous report was received from a nurse concerning a male, elderly, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and inadvertently vaccinated an elderly gentleman that had just been vaccinated.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 26 Jan 2021, it was reported that the outreach team inadvertently vaccinated an elderly gentleman that had just been vaccinated on Friday, 22 Jan 2021. The patient had forgotten that had received the vaccine.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, inadvertently vaccinated an elderly gentleman that had just been vaccinated, was resolved.; Reporter's Comments: This case concerns a male elderly patient who received a dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection, however, the outreach team inadvertently vaccinated an elderly gentleman that had just been vaccinated five days earlier. The patient had forgotten that he had received the vaccine. There were no reported adverse events after the vaccine was administered in this case of inappropriate schedule of vaccine administered.
Based on information received on 05-Dec-2018, the report previously considered as non-valid became valid: [as age of patient was updated]. Initial information received on 12-Nov-2018 regarding an unsolicited non-valid non-serious case received from a nurse. This case involves a 8 years old patient of unknown gender, he/she received vaccine FLUBLOK QIV. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were given. It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. It was reported that multiple patients received Flublok that were under 18. Medical errors due to packaging looking similar for Fluzone and Flublok. There was no adverse reaction. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none. Follow up information received on 05-Dec-2018 regarding an unsolicited non-valid non-serious case received from a nurse. Case updated to valid as patient age was updated. Documents held by sender: none.
Chills and fever starting five hours later Fainted twice around 17 hours later Rapid heart rate (up to 145 bps)
Was having a healthy pregnancy with heart beat. The week following the H1N1 vaccine my baby died. I found out about the death on 2/22/2010. Doctor told me baby died 2.5 wks before. No one in my family has ever miscarried. I was adamant about not getting this vaccine and in fact my husband witnessed my conversation with facility about me thinking this was a very bad idea. I didn't/don't believe that getting a vaccine that our government doesn't know enough about (statistically) or especially the effects on a fetus is a smart thing to do. I was told that I'd have to sign my rights away to decline this vaccine because of how dangerous it was for me to not get it. I was told that I fit the exact profile of people who are dying from the H1N1 virus.They drew a diagram about the swine flu and how it is different from the regular flu. At that point they competely made me think that I would die or my baby would die if I didn't get the vaccine. I then went back into the room I left and received it. Approximately 8 days later my baby died. The only symptoms I had was a slight fever and this was followed by severe migraines (after my baby died). When I went into my 10 week appt. the Doctor couldn't find the heartbeat (which we had heard before) and I was told the baby died at around 8 wks 1 day.
I wasn't feeling well. Was feeling very tired and run down. I had the doctor run some bloodwork. Certain things came up on that that has never been there: B12 was low; my blood sugar and liver tests were a little high; my thyroid appeared under active. The doctor wanted me to retake my thyroid test again - I have an appt in two weeks to go back to doctor in two weeks to plan of action. I am still feeling the same symptoms of being tired and run down. I fell in June (19th) down the stairs. It was raining and I was running from one awning to the other - I stopped to catch my breath and when I stopped, I started to feel like I was falling over, and I went to grab for something to stop me and I fell down 13 concrete steps when I didn't grab anything to stop me). I hit my head a couple of times on the railing. I had a concussion. I went to ER for that. They took X-rays and blood work and CT scan at that time. Nothing was broken but had a concussion. I went to the doctor because my arm was still hurting months after the fall. My doctor sent me for X-rays on right arm (September 30th for the X-ray) for that - nothing was broken but I have tendonitis in my right arm. That is a new diagnosis since I fell down the stairs. The doctor is sending me for a PT for the tendonitis. I haven't started the PT yet. I am still in process of healing. I don't know why tests have come back normal.
her arm is really rigid where the injection was given and still warm to touch; her arm is really rigid where the injection was given and still warm to touch; site sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 08:00 (Lot number: EN6201) at the age of 75 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PANTOPRAZOLE taken for gastrooesophageal reflux disease (ongoing). The following information was reported: MUSCLE RIGIDITY (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 22Feb2021, outcome "not recovered" and all described as "her arm is really rigid where the injection was given and still warm to touch"; PAIN (non-serious) with onset 22Feb2021, outcome "not recovered", described as "site sore".  Additional information: The patient did not require visit to physician or ER as a result of AEs. No Prior Vaccinations (within 4 weeks). No Family History. No Relevant test. The patient stated that the site is still very rigid and warm and feels like a solid muscle. Mentions she called her doctor's office and the nurse called her back and advised to put ice on the site and get the second dose in the other arm. Caller states she is scheduled to receive the second dose on Monday. Caller would like to know if she should receive the second dose.  No follow-up attempts are possible. No further information is expected.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to allopathic drugs (allergy to biaxin), Allergy to allopathic drugs (allergy to macrodantin), Allergy to allopathic drugs (allergy to azithromycin), Allergy to allopathic drugs (allergy to vantin), Allergy to allopathic drugs (allergy to travatan) and Allergy to allopathic drugs (allergy to eyedrops). Concomitant products included GABAPENTIN, TIZANIDINE HCL and EZETIMIBE for an unknown indication.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.         This case was linked to MOD-2021-307848, MOD-2021-320985 (Patient Link).
Information has been received from a medical assistant concerning an 8 week old male who on an unspecified date was vaccinated with ROTATEQ. It was reported that the patient was given ROTATEQ and regurgitated it and the patient was given another dose of ROTATEQ. At the time of reporting the patient's outcome was not reported. Unspecified medical attention was sought. Follow up information was received on 02-JUN-2009 from the physician's office explaining that they do not have any further information regarding this event. Additional information is not expected.
Pt recvd 2 doses of Recombivax followed by 4 doses of Engerix-B & all titer results through 17AUG92 were neg;
My mouth gums still hurts what can I do to ease the pain; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL PAIN (My mouth gums still hurts what can I do to ease the pain) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced GINGIVAL PAIN (My mouth gums still hurts what can I do to ease the pain). At the time of the report, GINGIVAL PAIN (My mouth gums still hurts what can I do to ease the pain) had not resolved.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   No concomitant drug information was provided.  Patient had adverse reaction from 2 weeks.  No treatment drug information was provided.
Information has been received from a consumer concerning an adult female who on 04/05/1997 was vaccinated with a first dose and on 05/17/1997 was vaccinated with a second dose of hep b vaccine recombinant. The pt's son reported that subsequently at an unspecified time post immunization, his mother "developed rheumatoid arthritis and other autoimmune disease." Additional info has been requested.
This non-serious spontaneous case, initially received on 12-Dec-2017, by other non-health care professional, concerning a 33-year-old, adult female pregnant patient with weight 110 lb and height 63 inches. The patient had one previous pregnancy with stillbirth or miscarriage occurred in the previous pregnancy. The patient had no history of tobacco, alcohol or illicit drug use and no concomitant diseases was reported. Concomitant medications included VITAFOL-ONE for healthy pregnancy. The patient's last menstrual period was reported as on 26-Jun-2017. It was reported that there was no evidence of a defect/adverse finding from a prenatal test. On 11-Sep-2017, the patient received AFLURIA QUADRIVALENT (batch number: 00644623A, dose, route of administration, anatomical location, expiry date: not reported) at 11th week of pregnancy. It was reported that neither the patient nor the foetus experienced any adverse event. The outcome of the event was not reported. The patient's EDD (estimated date of delivery) was reported as 02-Apr-2018.
About a week after the shot was given I broke out in a rash and hives.  Reaction was mostly on my torso.  Did spread to buttocks and forearms.  After three days or so I started taking an OTC allergy medication and applying hydrocortisone cream.  Seems to be responding to allergy medication and cream.  A week later and hives are almost gone.  Most of the itching has subsided.
full body rash; hives servers; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER2613), via an unspecified route of administration, administered in right arm on 29Mar2021 at single dose for COVID-19 immunization. The patient's medical history included 11 years post kidney transplant remission, Non hodgkins lymphoma. The patient's concomitant medications included sodium bicarbonate, gabapentin, morniflumate (FLOMAX), and clarithromycin (CLARITIN), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6202), administered in right arm on 08Mar2021 12:30 PM for COVID-19 immunization. The facility type vaccine was Public Health Department. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was tested for COVID post vaccination. On 01Apr2021 at 12:00 (4 days after the second shot), the patient broke out in full body rash and hives servers. All over getting worse. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization. The patient was hospitalized due to the events for 5 days. The patient underwent lab tests and procedures which included nasal swab: negative on 08Apr2021. Therapeutic measures were taken as a result of the events and included treatment with steroid IV therapy and benedryl, topical creams. The outcome of the events were not recovered.
No additional AE; The vaccine was administered after a temperature excursion/ Temperature: -14.1 degree Celsius, time frame: 12 minutes; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 18-JAN-2022, the patient was vaccinated with improperly stored (temperature: -14.1 degree Celsius, timeframe: 12 minutes) varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot #: U022321, expiration date: 15-JUL-2023 (strength, site and route of administration were not provided) for prophylaxis (product storage error). There was no additional adverse event reported (No adverse event).
Patient's arms is red at injection site and she has rash on her neck occurring at night post vaccine.
LEFT ANKLE WHERE SURGERY PERFORMED SWELLED EXTREMELY LARGE/EDEMA WITH CHRONIC PAIN. WENT TO THE DOCTOR REPORTING THAT I THOUGHT THE VACCINE CAUSED IT. HOWEVER, DR SAID HE COULD NOT BE SURE OF THAT. SPECULATED THAT MAYBE I HAD PUT TO MUCH PRESSURE OR STRESS ON IT DURING PT. DR PRESCRIBED A COMPRESSION ANKLE SLEEVE TO BE WORN IN DAYTIME BUT NOT TO SLEEP IN IT. I WAS NOT SATISFIED WITH DR'S CONSULTATION SO I REVIEWED THE INGREDIENTS FOR THE PFIZER VAC, NEXT I RESEARCHED THE SIDE EFFECTS OF EACH INGREDIENT AND SODIUM CHLORIDE INDICATED LOWER LEG, ANKLE AND FOOT SWELLING. REPORTED TO MY PHYSICAL THERAPIST. I BELIEVE THAT THE SODIUM/SALT SETTLED IN MY INJURED ANKLE AND CAUSED THE EXTREME SWELLING AND PAIN. I HAD NOT HAD SWELLING LIKE THIS SINCE I DISLOCATED AND BROKE MY ANKLE AS WELL AS AFTER SURGERY. USED THE ANKLE SLEEVE FOR OVER 3 WEEKS BEFORE SWELLING COMPLETELY WENT AWAY. DR RECOMMENED WEARING COMPRESSION SOCK DURING DAY BUT NOT DURING SLEEP. I AM STILL WEARING COMPRESSION SOCK IN DAY. PUT IN ON UPON WAKENING; IF NOT I GET SMALL AMOUNT OF SWELLING. PHYSICAL THERAPIST INDICATED THAT SHE COULD NOT STATE WHETHER THE VACCINE CAUSED THE SWELLING OR NOT AND RECOMMENDED THAT I CONTINUE WITH THE COMPRESSION SOCK UNTIL FURTHER NOTICE TO STOP USAGE.
Initial report was received from a health care provider on 04 January 2008. A 44-year-old female patient had received an intramuscular left deltoid injection of FLUZONE NO-PRESERVATIVE 2007-2008, lot number U2475KA, and on the day of vaccination, she complained of pain at the injection site. Two days later, the pain became severe. Corrective treatments consisted of MOTRIN. On 20 December 2007, the patient received a physician's evaluation and subsequent x-ray with negative results. According to the reporter, it was possible that the vaccine may have been administered too high in the shoulder area, possibly into the bursa. At the time of the report, the pain intensity was mild and the patient reported a shooting pain through the arm when the shoulder was abducted. The patient had pre-existing allergies to penicillin, amoxicillin and CECLOR and had not been ill at the time of vaccination. Concurrent medications included "VITORIN". At the time of the report, the patient had not recovered from the event. Follow-up information was received 14 May 2008 from a health care professional. According to the reporter, the patient had no history of arm pain. The pain at the injection site began immediately after vaccination and was severe for two days (previously reported as "two days later, pain became severe"). The pain was located high on the patient's left arm just below the joint. An X-ray of the patient's left shoulder was performed with negative results; no bone or joint abnormalities and no soft tissue calcification were seen. The patient was evaluated by a specialist and diagnosed with Subacromial Bursitis and soft tissue inflammation secondary to FLUZONE. She had been evaluated by the specialist on 04 January 2008, 21 January 2008 and 18 February 2008 (evaluation results not reported). On 06 May 2008, the patient reported to their health care provider that their "arm is good now, sometimes hurts to lift, still tender to touch". No further information was provided at the time of the report.
tingling, pain, and numbness of the radial nerve from the armpit to the fingertips
Muscle twitching in right arm/ Twitching all over body; Pulsing kind of sensation; Inappropriate schedule of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Muscle twitching in right arm/ Twitching all over body), PULSE ABNORMAL (Pulsing kind of sensation) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for Hypertension, LEVOTHYROXINE SODIUM from 07-Apr-2021 to an unknown date for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced MUSCLE TWITCHING (Muscle twitching in right arm/ Twitching all over body). 22-Apr-2021, the patient experienced PULSE ABNORMAL (Pulsing kind of sensation) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine). At the time of the report, MUSCLE TWITCHING (Muscle twitching in right arm/ Twitching all over body) and PULSE ABNORMAL (Pulsing kind of sensation) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) had resolved. Not Provided          No treatment details were added.  Patient reported that the symptoms started 5 minute after the second shot. Twitching spreaded to stomach, arms, legs on the night. During day it was more and during night less.  Levothyroxine was indicated for thyroid.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Patient demographics added, added details of concomitant medications, adverse event details and outcome of the event updated
I experienced extreme aches, rash, and pains on the following day (3"); then, the next day, (4") it was really hot and swollen and then the following day the size increase to 4.2." By Monday, it increased in swelling. I called the Urgent Care Nurse and she told me to take Ibuprofen; however, I took Tylenol and put ice on it. On Tuesday, I called my doctor and he was not ablle to get back to me until 09/07/2021 and by then it was getting better. It's still red, warm, and swollen but it's not as bad. I was surprised because I didn't have a reaction after the previous dosages of the vaccine.
Pt vaccinated with DTP developed temp 102, screaming, redness at injection site.
Went to go vaccinate patient, which included a prick on arm when noticed vaccine was frozen. I removed the needle and discarded vaccine. I then went and re-drawled a new vaccine and administrated to patient. Patient was okay with the process after explaining.