chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gave vaccines at around 10:15 AM. Afterwards patient requested vaccine records be in sealed envelope. This RN printed records, stamped them, and sealed records then brought them to patient at 10:30. At this time patient asked if her arm was having a "normal reaction." Pt showed this RN her right arm in which the varicella and moderna bivalent vaccines were administered IM. Superior to vaccination sites and closer to where varicella was administered there was a hard knot slightly larger than a quarter that was tender to the touch. No erythema or discoloration at site. This RN got another RN to examine site, obtained a full set of VS at 10:37 (HR: 80, BP: 130/90, and O2: 93%) and assessed for signs of anaphylaxis. Patient's face was flushed and she endorsed feeling dizzy then shortly after endorsed stomach pain. Administered 50mg PO Benadryl with second set of VS at 10:45 (HR: 84, BP: 134/92, O2: 92%). Messaged senior nurse practitioner who was onsite to inform her of situation. Simultaneously second nurse called Dr. who happened to be entering building at this time. Dr. is familiar with patient from different clinic, assessed patient, and patient informed Dr. she felt better. Obtained one more set of VS at 11:05 (HR: 70, BP: 130/90, O2: 98%). By this time patient endorsed no signs and symptoms of anaphylaxis and left building at 11:15, roughly 1 hour after vaccination. Patient educated on signs and symptoms of anaphylaxis and instructed to call 911 if symptoms arise later. VAERS report
5 days after shot my righ had went numb and I had an ice pick headache worse than I've had before.  About three weeks after the palpitations that I had gotten after shot 2 and 3 came back but much worse.  I had to spend 90% of my time in bed because of chest pain.  I could not go up the stairs, do laundry or wash dishes.  I am currently 7 months post shot and being treated by an neurologist, cardiologist and rhematologist.  I have elevated anticardiolipin antibiofies so being checked for antiphospholipid syndrome.  Also have had three MRIs of my brain for inc head pain, it is intense squeezing.  In the last month they have progressed to hemiplegic migraines where I cannot move my right leg.  This is the same leg that got swollen after shot number 3 but since I was pregnant at the time my doc thought it was that.
pt recv vax 10AUG98 & 11AUG98 pt exp joint pain & stiffness w/flexion in lt hand & pink macules on both hands but worse on lt hand;pt sought unspecified med attention;
Gave children's Advil prior to coming for shots. After final injection in her rt arm she cried unusually hard because of the pain. That night she complained that both arms hurt but continued to complain of her right arm that  was swollen from right shoulder to the elbow with a red circular area 4-5" in diameter. Continues swelling, and red today but feels better overall and in school today.
Information has been received from a nurse via a field representative referring to a 4 month old female patient. The patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with the second dose of ROTATEQ (dose, strength and lot# unknown, oral). On an unknown date the patient had weeks of guaiac positive stools. The patient sought medical attention by seeing unspecified physician. The patient was milk-free for a month to rule out a milk allergy. However even without the milk the patient still had heme positive stool. At the time of reporting, the outcome of the event was unknown. Additional information has been requested.
Rx axillary lymph node swelling and rt arm discomfort. Cellulitis requiring hospitalization and IV-ABX sent home with picc line and IV-ABX developed clots hospitalized again. Dc'd with PO ABX and Coumadin. DVT's L arm Discharge summary states synovitis. msv
fever; headache; This is a spontaneous report from a sponsored program.   A contactable physician reported that a female patient of an unspecified age received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient experienced fever and headache after the second dose on an unknown date and would like to know if it was okay to give tylenol for the patient. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
MOTHER STATED THAT MILES GOT A LUMP TWO DAYS AFTER COMVAX WAS GIVEN. NO FEVER, CHILD WAS NEVER FUSSY.
right before his second vaccine dose, he started have very prominent palpitations, could not lie down at night while sleeping, had to sleep elevated or it was difficult to get his breath, had to lean forward to breath during episodes.  During the second week of symptoms, he started having pain in his left shoulder and arm Symptoms were intermittent and worse in the evenings
Injection site redness; Injection site itching; This case was reported by a consumer and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced erythema and pruritus. On an unknown date, the outcome of the erythema and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the erythema and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient experienced redness and itching about an inch below the injection site which started a day after injection and had continued a week after injection. It was very itchy at times. The patient asked what was the usual range of time. The patient was concerned about the reaction as it was lasting for a week. The pharmacist reported that the individual responses can vary, but the majority of solicited local adverse reactions and general adverse events seen with Shingrix in the two pivotal clinical trials had a median duration of 2 to 3 days.  Solicited adverse reactions were collected for 7 days after each dose. Some patients may continue to experience reactions beyond 3 days. Unsolicited adverse events were collected for 30 days after each dose. The pharmacist recommend that if localized reaction occurs, such as soreness, redness, itching, or swelling at the injection site, apply a cold compress to the injection site. Consider giving an analgesic (pain reliever) or antipruritic medication.
Pt exp sz approx 10min p/receiving inject; tx epi, & VS monitored; pt sent home p/stable;
had both shots yet endured hell on earth/suspected vaccination failure; endured hell on earth; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had both shots yet endured hell on earth/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: endured hell on earth). The patient was treated with CANNABIDIOL (CBD) and DRONABINOL (THC). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 17-Mar-2023 The case was received from the patient's partner via interactive digital media. The patient had both of the shots, yet endured hell on earth for over a month. The only relief the patient got was from CBD infused with THC. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Information has been received from a certified nurse practitioner concerning herself, a 60 year old female with seasonal allergy and a history of hysterectomy who in September or October in 2009, was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included "PROVIDUAL" DYAZIDE, LIPITOR, ALLEGRA, estradiol, aspirin and vitamins (unspecified). In November 2009, the patient experienced multiple episodes of shingles after getting the ZOSTAVAX vaccine. She regretted getting the vaccine, also stated that might be the tech injected too much medicine in the vaccine. There was unspecified lab diagnostics studies performed in October 2010 (last fall). The patient sought unspecified medical attention. The patient was treated with acacia, neomycin, gentamicin. At the time of the report, the patient had not recovered from her adverse events. The patient sought unspecified medical attention. Additional information has been requested.
Tingling in lips, and upper extremities, resp 36050/min, Epipen left thigh - monitored X 30 mins (180182) pre vaccine 118/70, 02 Sat > 97. No oxygen given. Zyrxets 10 mg 1x / day for 1-2 days.
Patient developed localized swelling at injection site but no other adverse symptoms. Cold pack was applied to site for 10-15 minutes with swelling diminishing.
This initial spontaneous case, was received on 17-Oct-2017, from other health professional (nurse), concerning a 48-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 01-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: XF31507, expiry date: Jun-2018). On the same day, between 30 minutes to 1 hour after administration of vaccine, the patient developed hives, lumps and rashes around the injection site. Outcome of the events was not reported. The reporter assessed this report as non-serious. Follow up received on 27-Oct-2017: The dose (0.5 ml), route of administration (intramuscular) and anatomical location (deltoid) were updated. The reporter stated that, it was unknown if the patient still had lumps. The narrative was amended accordingly.
A report was received from a health care professional on 21 October 2003 concerning a 66-year-old female vaccinee who experienced breathing difficulty and chills 3 days after receiving Fluvirin on 17 October 2003. On 20 October 2003 the vaccinee experienced breathing difficulty and chills. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
little bit of a sore arm/like I've had on the other Pfizer shots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9269) at the age of 69 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Blood Pressure" (unspecified if ongoing), notes: he takes a blood pressure pill and a tablet for urinating; "Urinating" (unspecified if ongoing), notes: he takes a blood pressure pill and a tablet for urinating. Concomitant medication(s) included: SERTRALINE. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "little bit of a sore arm/like I've had on the other Pfizer shots". Therapeutic measures were taken as a result of pain in extremity.  Additional Information: When he had sore arm he took some Tylenol and Ibuprofen, which was 500mg for Tylenol, which he took a couple of times as needed. For the Ibuprofen dose would have been 200mg, which he took the same as the Tylenol, a couple of times as needed. Ibuprofen was taken at same time as Tylenol. His sore arm got better. Concomitant Medications: He takes his regular medications, like he takes a blood pressure pill and a tablet for urinating, and he takes Sertraline.  Reporter said he does not feel those are relevant, he had been taking all of them for 4-5 years and did not have neck spasms.
Patient for Moderna booster 0.25ml dose. Nurse drew up and gave 0.02ml. Patient returned from waiting area and given full 0.25ml dose
pt recv vax 20MAY97 & 26hr p/vax T101.5;began crying unusual high pitched, primitive cry for 1 full hr;next hr very irritable;exhausted, slept all noc;
cough 1 wk p/shot; h/a, congestion 1 wk p/shot & cold like; no fever (temp not taken);
Chills, Generalized Body Aches, Cough, Headache, Fatigue.
About one week after the vaccine, I woke up at 4AM and the room was spinning. When I sat up it got better. I laid back down and the room started spinning again. I continued to sit up but it had not improved by morning. It was positional and it did not effect me when I was sitting, walking or standing. My doctor sent me to the ER. I was tested and they suspected it was crystals in my inner ear. I was given medicine for my inner ear, and it seemed to work within an hour. I did not have the spinning feeling. When the medicine wore off it came back. I did some exercises that were advised for inner ear crystals. It has been five days and now it has improved, I have not had any symptoms today.
Extreme fatigue, whole body soreness, tenderness onset roughly 3 hours post injection, persisting at least two days.
The pt stated, she experienced nausea, weakness, rash on legs. Seen at a clinic and was told the reaction due to Hep b vaccine.
Information has been received from a pharmacist referring to a 61 years old female patient. The patient had no concomitant therapy, medical history or concurrent condition. On 14-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 (lot # M029681, 0.5 ml, expiration date of 22-JAN-2018) intramuscularly for prophylaxis. The patient was also administered ZOSTAVAX ("single dose", lot # M037654, expiration date of 29-NOV-2017) subcutaneously in the left arm for prophylaxis on the same date (Inappropriate schedule of vaccine administered). The other suspected therapy also included an unspecified influenza vaccine (administered on 14-AUG-2017). The injection sites for PNEUMOVAX 23 and influenza virus vaccine (unspecified) were all in the left arm, at separate sites (Vaccine administered at inappropriate site). In the evening of 14-AUG-2017, the patient experienced redness at the site of injection of PNEUMOVAX23, and redness and swelling at the site of zoster vaccine live (ZOSTAVAX). On 15-AUG-2017, the patient experienced chills. The patient came to the pharmacy on 16-AUG-2017 and the pharmacist suggested her take ibuprofen and applied ice to the injection sites. The patient was not recovered from the events. The relationship between events and therapies was not reported.
Information has been received from a licensed practical nurse concerning a 16 year old female patient who on 19-JUL-2010, was vaccinated SQ with a dose of ZOSTAVAX (Merck) (Lot#: 665525/0695Z). The licensed practical nurse mentioned that the patient inadvertently was administered a dose of ZOSTAVAX (Merck) as her second dose in the VARIVAX (Merck) schedule on 19-JUL-2010. The first dose of VARIVAX (Merck) (Lot#: not reported) was given on 03-JUN-1998. No adverse effects were reported. This was a human error, there was no a PQC involved. Follow-up has been received from a licensed practical nurse concerning a 16 year old female student who on 19-JUL-2010, was vaccinated SQ in the right arm with the first dose of ZOSTAVAX (Merck) (Lot# 665525/0695Z), IM in the left arm with the first dose of GARDASIL (Lot# 665547/1318Y), IM in the left arm with the first dose of MENACTRA (Lot# U3432AA), IM in the right arm with the first dose of ADACEL (Lot# UF544CA) and IM in the right arm with the first dose of ENGERIX-B (Lot# AHAVB437AA). There was no illness at time of vaccination, no pre-existing allergies, no birth defects, no medical conditions, no relevant diagnostic test and there was no adverse events reported. No further information is available.
The night of my vaccine dose (5/26/2021), I experienced chills, aches, and a low grade fever. The next day, the symptoms continued but lessened. However, beginning on 5/28/2021, I was experiencing shortness of breath. I would feel like I would need to catch my breath even when I was just sitting down. For the following two days (5/29 and 5/30), I experienced shortness of breath but it slowly lessened with each passing day. I'm feeling fine now but it was scary especially since shortness of breath isn?t listed as a common symptom. I also wanted to mention that I did have momentary bouts of  shortness  of breath with my first covid-19 moderna dose (4/28/2021) but it was much less severe and went away quickly.
Severe headache since 1-11-21. Knot in arm at injection site. (Ongoing) Last night (1-19-21) I noticed injection site was hot and had redness. (Ongoing)
Patient was brought into the ER on Sunday and reported that since vaccinations had been febrile, lethargic, and irritable. Patient was anorexic as well. Pushing fluids and discharged home. The next day patient was brought back to the ER, temp of 103, 2 wet diapers in a 48 hour period, 1 bout of diarrhea, poor PO intake both food and liquids. Patient was admitted to the hospital and given IV fluids, dextrose before patient started to feel better
Chills, body felt like it was burning  could not move arms legs and fell down when tried to go to the bathroom.
Information has been received from a female consumer reporting on herself who on an unspecified date was vaccinated with a dose of MERUVAX II (Lot# and expiration not reported). Consumer reported that she had a hypersensitivity reaction after getting MERUVAX II over 20 years ago. It was unspecified if the patient sought medical attention. The outcome of the patient was unknown. No further information is available.
Local reaction at injection site 3 days after injection after IPV & MMR to left arm. One-two weeks of erythema, firmness near center & slightly dusky. Area 3 X 3 cm.
Site: Pain at Injection Site-Medium, Additional Details: whole body tremor, lower back pain. Blood O2 was 99%, HR 76bpm. Unsure of the reaction, benadryl and epipen were given. Pt went home walking after 20 mins of the event. Paramedics did not arive on time and were cancelled after pt went home. Pt was advised to see PCP
On 11/12/2021 patient had a massive heart attack caused by a spontaneous arterial dissection. Emergency surgery involved 3 stents and a balloon pump was placed. Flown to another state for care. Patient then had major stroke with 3.5 months to recovery.
Pressure in chest when laying down; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 08Jun2021 at 15:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 19May2021 at 08:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient previously received azithromycin (MANUFACTURER UNKNOWN) on unknown date for an unknown indication and experienced drug allergy. On 15Jun2021, the patient experienced pressure in chest when laying down. This occurred a week after the second dose of vaccine and lasted for a week. Three weeks after the second dose, the patient had pressure in his chest when taking a deep breath. This pressure was just to the right of his sternum. This lasted for about 10 days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event pressure in chest when laying down was resolving at the time of this report.
Report 2001012946-1 describes rash in a pt of unspecified age and gender who rec'd hepatitis B vaccine recombinant (Engerix-B). Allergies, medical history, and concomitant medications are unspecified. On an unspecified date, the pt rec'd a dose of Engerix-B, it was not known whether the pt had rec'd previous doses of Engerix-B. Subsequently, the pt experienced a rash. as of 5/22/01, the outcome of the event was unknown.
No adverse event; HCP stated they accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after the expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     Patient had no known relevant medical history, allergy,concomitant diseases and risk factor. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 26-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after the expiration date).    No concomitant information was reported. Suspect product dosage text was reported as unknown. The 2.5ml vial was thawed directly from the freezer each time they needed to administer a dose. The vial did not underwent temperature excursions. No treatment information was provided. This case is reported for patient 2 out of 9 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-729345 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729345:same reporter