chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Facility nurse and pharmacist reviewed all the consent forms for the clinic prior to going to rooms, all were signed.   Nurse grabbed vaccination cards only and the nurse and pharmacist headed to the rooms.  Pharmacist administered vaccine to patients nurse said only received 1 vaccine per the card.  They failed to check if the consent forms matched up with the cards.  The card for patient did not get filled out at the second clinic but the pt did receive the second shot.  When the nurse and pharmacist entered the room the pt stated " I already received both of my shots" nurse replied, "no you only got one shot you need one more."  With no consent form to compare to the pharmacist administered the vaccine.  After pharmacist left for the day the nurse realized when matching cards up with consent forms that there was not a consent form for the pt.  After going through the consent forms from prior clinics they realized the miss on the documentation on the vaccine card and the error of the third vaccine.  Facility contacted pts physician whom advised to monitor pt.
patient developed erythema at the injection site.  he became nauseous and near syncopal.  he then complained of chest tightness and DIB.  Benadryl and two doses of epi given with no relief of symptoms.  No facial swelling, wheezing, drooling, or hypotension.  he was talking in sentences.
After leaving the clinic, my arm became weaker and weaker and began to hurt badly. I could not lift my arm more than 3 inches for 2 days, then continued to have pain and arm weakness for one week. At 9 days, the arm began to feel better and I only had pain when lifting my arm to eye level. At day 11, the arm began to hurt worse and grow weak again. I am now at day 17 since the shot and the arm hurts when at rest and is painful to lift. It hurts from the injection site at the top of my shoulder all the way down to my inner elbow.
This spontaneous report as received from a nurse refers to a 70-year-old patient on unknown gender. The patient's medical history, concurrent condition and drug reactions or allergies were not reported. On 05-JUN-2018, the patient was inadvertently given a dose of PROQUAD subcutaneously, lot# N025719, expiration date: 17-MAR-2019 (frequency was not reported) instead of ZOSTAVAX, for prophylaxis.
26MAR92 pt taken to ER for ? elevated temp, limping, red swollen leg;
Localized reaction at injection site with blisters. Red swelling warm to touch. Pain relieved ibuprofen x 4 days.
Daptacel - Left deltoid IM, MMR - left deltoid SC. After 48 hours administration time period, the patient's arm at the Daptacel site became red, warm and swollen. No fever followed the reaction.
Twelve Moderna vaccines were given in office. Only 11 were drawn up this morning and the 12th dose was, most likely, a left over dose from yesterday. After incident was discovered, Moderna manufacturer was contacted per CDC recommendation. (Case #: MOD21-060693). Staff in Quality was also notified.  Communication to patient: The Moderna Vaccine you  received may have been outside of the 6 hour thaw recommendation. We contacted the Moderna manufacturer and CDC. At this time, there are no recommendations for revaccination. You will still receive your 2nd dose as previously scheduled. Titers will be available at no cost in 2-3 months after your second vaccine.
Patient is complaining of pain at injection site, stated he was up most of the night in agony & lost function of his right arm. I advised to treat with cold compress & OTC pain reliever.
Last Thursday (4/8/21) morning woke up and noticed pink eye right eye, used antibiotic drops. No longer occuring. Thursday (4/8/21) 9pm debilitating headache that lasted for 18-20 hrs, diarrhea.  Saturday (4/10/21) morning - lethargic, malaise Saturday same day 6PM - joint ache whole body, slight fever 100.5F, chills & sweating, stomach trouble all through the night and into sunday Today (4/12/21), no more joint pain or diarrhea, but other symptoms still present Recommendation: Drink lots of fluids such as pedialyte due to your diarrhea. Contact PCP. Get tested for the Flu or covid-19 to rule that out.
LARGE RED AREA (APPROX 2 INCHES IN DIAMETER), LOOKED LIKE BLEEDING UNDERNEATH SKIN.
Received Heplisav-B then Two Doses of Engerix; Initial Report Received on 22-Jul-2021  A licensed practical nurse (LPN) reported that a 27 year-old male (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and 2 subsequent doses of Engerix.   No relevant medical history was reported.  No relevant concomitant medications were reported.  On 18-May-2020, dose 1 of HEPLISAV-B (Lot #, expiration date, NDC #, and serial number all unknown).   On 30-Oct-2020, 166 days after having received dose 1 of HEPLISAV-B, dose 1 of Engerix (hepatitis B vaccine) was administered.  On 02-Apr-2021, 320 days after having received dose 1 of HEPLISAV-B, dose 2 of Engerix (hepatitis B vaccine) was administered.    No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Moderna COVID-19 Vaccine EUA. Welt and itching at injection site, measures about 2" by 1" appearing on day 10. Searched adverse reaction and found article. My symptoms were very similar so I'm not worried at this point.
Dizziness, nausea 5/19/04. Swelling erythema at site 5 cm x 3 cm with induration warm to touch. Patient complains of feeling shaky and she passing out.
Finished ral typhoid on Tuesday. Became feverish and achy on Thursday, with "violent chills". Symptoms subsided on Sunday.
Info has been received from a licensed practical nurse concerning her 46-year-old husband who is a machinist and volunteer firefighter and who has allergies to penicillin (unspecified), dustmites and some trees and weeds who on 12/02/2002 at 7:00 PM was vaccinated IM in the deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). There was no illness at the time of vaccination. No adverse events following prior vaccinations for the pt or his siblings were reported. Concomitant therapy that day at 7:00 PM included a 1x every 10 year dose of influenza virus vaccine (FLUZONE) (Batch #U0925AA) given IM in the opposite deltoid. Additional concomitant medications included cetirizine hydrochloride (+) pseudoephedrine hydrochloride (ZYRTEC-D) given q12h and budesonide (RHINECORT) nasal spray. Subsequently, the pt developed redness and induration from his elbow to his shoulder. It was reported that symptoms resolved without treatment in a couple of days. Follow up info received from a licensed practical nurse indicated that on 12/03/2002 at 9:00 PM the pt developed pain, redness and swelling, and it was noted that the area from the shoulder to the elbow was hot to the touch. No medical care was required as a result of the reaction. It was noted that 2 hours after receiving the vaccination, the pt was called out on a major structure fire and spent the next 20 hours at the fire scene engaged at times in heavy physical labor. The reporter indicated that she suspects that "this activity played a major role in their reactions". It was noted that on 12/09/2002 the pt recovered. No diagnostic tests or laboratory data were reported. The reporter indicated that 9 other pt received a dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445) and developed induration at the injection site (WAES #0212USA00729, 0212USA00825, 0212USA01193, 0304USA02075, 0304USA02076, 0304USA02077, 0304USA02078, 0304USA02079 and 0304USA02081). No further info is expected.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: Er2613) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Age group reported as (18-64 Years). No other medication in two weeks. It was reported that anti viral Paxlovid stated on 20Jul2022 and stopped on 25Jul2022 for COVID 19 Treatment.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Seizures; This is a spontaneous report from a contactable consumer (patient's mother)   A 26-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Aug2021 16:00 (Lot Number: EW0181) as single dose (at the age of 26) for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced seizures on 05Aug2021 (about an hour and a half or an hour and 20 minutes after the vaccine). She states her son has never had a seizure before. Caller states her son had 2 seizures minutes apart the day before yesterday. Then he had a seizure yesterday as well. Caller states that her son went to the emergency room and yesterday he went to his family doctor. Monday he is going to a neurologist so they can do testing to determine what type of seizures he is having.The outcome was not recovered.    Follow-up (24Aug2021): Follow-up attempts are completed. No further information is expected.
Rec'd varicella 4/7/09. At 3:30am on 4/9/09 woke up w / 104 Temp. Used fever control methods. Saw PCP at 9:30am on 4/9/09, temp at 99. Large, raised red area on arm where immunization given. This was #2 varicella, #1 was given in 2003. Had a few "spots" come up at that time.
Date I got vaccinated: Nov 2 12:46 pm  Around 2 pm on Nov 2  I started feeling the usual symptoms. The site where I got vaccinated hurt. It was hurting to breathe when I tried to take  a deep breath.  I was tired, nauseous, dizzy, and had aches all over my legs. I was getting cramps (felt like period cramps) and I was ovulating.  9 pm that same day is when I tried to rest, that's when the side effects got worse. My face felt like it was burning. My hands started shaking, I kept tossing and turning. I kept putting blankets on then taking them off.  At 1 am Nov 3rd I had a bad throbbing headache and I still kept taking things on and off. I even took my clothes off.  It felt like my body couldn't decide if it was too hot or too cold.  I had very bad upper leg pain. I tried to get up to move my legs and walk around but that didn't help. I also had frequent urination (5 times the whole night whereas my usual is once or twice). I then decided to eat an apple in hopes it would help me but then a couple hours later (3 am) I felt very nauseated, like I was going to throw up.   On Nov 3rd (7 - 9 am) I still had a headache, nausea, leg pain, and pain around the injection site. All of the symptoms went away that afternoon Nov 3rd except pain at the injection site.  I had lingering pain that stayed at the injection site until Nov 6th.  On Nov 6th I got my period very early, and had light flow. My last period was Oct 23-27th. So there was a 9 day gap between periods.  Luckily I recovered from all of my symptoms. I just thought it would be important to report this since the night of my injection was very intense and I was very anxious.
The vial was initially stored in the refrigerator 25Feb2022 and  date administered on 20Apr2022; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and  date administered on 20Apr2022) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient had no known drug allergy or medication and food.  Concurrent medical conditions included Sarcoidosis, Type 2 diabetes mellitus and Multiple myeloma. Concomitant products included SIMVASTATIN, ZOLEDRONIC ACID MONOHYDRATE (ZOMETA), METFORMIN, DEXAMETHASONE, LISINOPRIL, LEVOTHYROXINE and GABAPENTIN for an unknown indication.    On 20-Apr-2022 at 9:26 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022 at 9:26 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and  date administered on 20Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and  date administered on 20Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received other medication such as Acyclovir Dose administered after 30 day use by date or after manufacturer date of expiry. Number of doses or vials administered 36 doses. Date and time the vial was initially stored in the refrigerator 25-Feb-2022. Date and time of administration of vaccine was 01-Apr-2022 and 08-Apr-2022. The vial had not undergone any temperature excursion.  No treatment medications were reported
Nausea, headache, and fatigue. All side effects gradually disappeared after 24 hrs.
Full loss of facial hair. Partial progressive loss of pubic hair. Occasional loss of eye lashes.
Patient called around 9:30am and stated that when we woke up numbness in arm he received the shot in and tingle (pen and needle feeling) in fingers of the same arm.
sore; joint pain; could hardly walk; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (sore), ARTHRALGIA (joint pain) and GAIT DISTURBANCE (could hardly walk) in a 59-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (sore), ARTHRALGIA (joint pain) and GAIT DISTURBANCE (could hardly walk). At the time of the report, TENDERNESS (sore), ARTHRALGIA (joint pain) and GAIT DISTURBANCE (could hardly walk) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient received the Moderna COVID-19 vaccine, was sick for 2 days after receiving the vaccine. Patient was sore and had joint pain for 2 days. Patient could hardly walk the day after receiving the vaccine. Patient did not have any additional details for her best friend. Treatment medications were not reported.
dose number: 3; achy; fatigued; red itchy spots on the top of my right thigh and left side of my chest/ many more red itchy spots on my lower back and  bottom; red itchy spots on the top of my right thigh and left side of my chest/ many more red itchy spots on my lower back and  bottom; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Dec2021 12:00 (Lot number: FD7218) at the age of 56 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "tree nuts" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; TOPROL XL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8727, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 23Mar2021, when the patient was 55 years old, for COVID-19 immunization, reaction(s): "low grade fever", "body aches", "Chills", "Fatigue", "tiny red itchy spots on my abdomen", "tiny red itchy spots on my abdomen"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Right), administration date: 02Mar2021, when the patient was 55 years old, for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 12:00, outcome "unknown", described as "dose number: 3"; PAIN (non-serious) with onset Dec2021, outcome "not recovered", described as "achy"; FATIGUE (non-serious) with onset Dec2021, outcome "not recovered", described as "fatigued"; ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset Dec2021, outcome "not recovered" and all described as "red itchy spots on the top of my right thigh and left side of my chest/ many more red itchy spots on my lower back and bottom". Therapeutic measures were taken as a result of pain, fatigue, erythema, pruritus.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 1 week later developed a few tiny red itchy spots on my abdomen. These spots continued to develop and cause discomfort for 4 months all over my body. My primary care physician prescribed steroid creams. Did not help much, but spots kept appearing on my body. Finally saw my dermatologist who prescribed a stronger cream. Not sure if the cream did the trick or not but the spots finally turned brown and stopped itching. Third shot booster felt achy, fatigued and that same evening developed some red itchy spots on the top of my right thigh and left side of my chest. These spots are slightly bigger than last time. A month later 15Jan developed many more red itchy spots on my lower back and bottom. They are currently active and again everyday new ones appear, causing discomfort and concern.  No follow-up attempts are possible. No further information is expected.
joints swelled; had increased pain; difficulty walking; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 immunization; Bnt162b2 (Dose:2), for Covid-19 immunization. The following information was reported: JOINT SWELLING (non-serious), outcome "unknown", described as "joints swelled"; PAIN (non-serious), outcome "unknown", described as "had increased pain"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "difficulty walking". Therapeutic measures were taken as a result of joint swelling, pain, gait disturbance.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 73-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (PFIZER BIONTECH COVID-19 VACCINE BIVALENT), on 08Sep2022 as dose 6 (booster), single (lot number GJ2524) at the age of 73 years, in right arm for covid-19 immunisation; BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 04Apr2022 as dose 5 (booster), single (lot number FK9893), in left arm for covid-19 immunisation; covid-19 vaccine as dose 1, single (lot number unknown), as dose 2, single (lot number unknown), as dose 3 (booster), single (lot number unknown) and as dose 4 (booster), single (lot number unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing). The patient had no known allergies. Concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) and COVID-19 (medically significant) both with onset Dec2022, outcome "unknown" and described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective and covid-19 which included Paxlovid taken from 18Dec2022 to 22Dec2022.
Received 2nd dose in the morning of  2 15 21 , by evening was starting to have fever, chills, nausea and body aches. Symptoms were present on the 16th, on the 17th symptoms were starting to be less noticeable, but that is when the tinnitus started and is still present today. No previous history of tinnitus or hearing problems, very healthy 66 year old femal.
Rash/hives on right and left upper arm, arm pits, and back.  This occurred 5 days after the second dose.  The rash is itchy.
Information has been received concerning a 2 month old male who on 26-APR-2001 was vaccinated with HIB vaccine. On 01-MAY-2001, the pt experienced hypotonia, laryngeal edema, vomiting, retching, lethargy and drowsiness and was hospitalized. This was originally reported by a RN. No further information available. This report was received from manufacturer and was assigned manufacturer report number HQ6048117SEP2001. Follow up info has been received indicating that on 4/26/01, the pt vaccinated concomitantly with Infanrix, Engerix B, and IPOL as well as haemophilus B conjugate vaccine. No lot number info was provided. The pt was released from the hospital the afternoon following administration. The pt's mother subsequently reported the pt was "back to normal." This was originally reported by a registered nurse. No further info is available. Further follow up info received indicated that the pt was released from the hospital the afternoon following admission not following administration as previously reported. This was originally reported by a registered nurse. No further info is available.
I felt really crummy all around/ just not myself; Was achy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I felt really crummy all around/ just not myself) and PAIN (Was achy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 09-Apr-2021, the patient experienced FEELING ABNORMAL (I felt really crummy all around/ just not myself) and PAIN (Was achy). At the time of the report, FEELING ABNORMAL (I felt really crummy all around/ just not myself) and PAIN (Was achy) had resolved.            Patient did not want to have 2nd booster as the patient had reaction with booster and 2nd dose.  No concomitant medication was reported by reporter. No treatment medication was reported by reporter.  Reactions did not cause patient to seek medical care or emergency room visit or hospitalized.   This case was linked to MOD-2022-561889, MOD-2022-561912 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2022: Follow-up was received and included no new information