chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an approximately 75 years old female patient with hypothyroidism, high cholesterol and depression refers to herself. The patient had no drug allergy. The patient was vaccinated with a dose of ZOSTAVAX (lot# unspecified) one injection subdermally in the upper arm about a year after the shot came out in approximately 2007. No other co-suspects were reported. Concomitant medications included SYNTHROID, ZETIA and PAXIL. The patient stated that she had shingles two times since she had received ZOSTAVAX. She experienced shingles and went to the doctor "this past Saturday" on 22-DEC-2012 and was given some pills she had to take 5 times a day for 7 days. She also stated that she got the shingles a couple of months after getting the vaccine (in approximately 2007). She said she did go to the doctor. She was prescribed a pill but could not tolerate it. The outcome of shingles was unknown. No lab test was performed. Additional information has been requested.
This spontaneous report was received from licensed practical nurse via a company representative, and refers to a 20 year female patient. Information regarding the patient's current conditions, medical history, concomitant medications and drug reactions/allergies was not provided. On 30-JUN-2017, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB (dose number, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. No adverse event reported. On 19-DEC-2017, a telephone call was received from Licensed Practical Nurse reported that there were no additional issues reported by the patient and requests no additional contact. No further information is available.
MORNING AFTER INJECTION MOM NOTICED RIGHT ARM TO BE RED AND WARM. DAYS CONTINUED AND SITE BECAME LARGER IN REDNESS AND RAISED AND CLIENT COMPLAINED OF SITE ITCHING. MOM HAS GIVEN BENADRYL FOR ITCHING. SITE TO RIGHT ARM TODAY IS RED, RAISED, AND WARM TO TOUCH. SITE TODAY MEASURES 4 INCHES IN HEIGHT BY 3 3/4 INCHES IN WIDTH. ECN MOM TO TAKE TO PCP,  AND MOM AGREED TO CALL TODAY OR IN THE MORNING.
No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from a reporter concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies or concomitant therapies were not reported.  On 29-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot # T033814, expiration date 05-OCT-2022) as prophylaxis (dose, dosage schedule, route and site of administration were not reported). The vaccine was storage at 12.4 degree Celsius for 53 min, at 9.6 degree Celsius for 34 min, at 9.5 degree Celsius for 23 min, and at 8.5 degree Celsius for 9 min. No previous temperature excursion occurred (product storage error). No adverse events reported.; Sender's Comments:  US-009507513-2112USA006870:
Pt recv vax on 3/7/99; on 3/09/99 pt exp paresthesia; on 3/10/99 pt exp exacerbation of herpes on buttocks, achiness, fever
PT received 4 immunizations on 3/20/03. When picked up from babysitter 3/21, noted warm, red, swollen right thigh. Sx's worsened until seen on 3/23/03 and treated w/Keflex Nodup. Seen 3/24 with improvement. Dx cellulitis vs. severe immunization local reaction. PE otherwise normal. Recovered by 3/27/03. Firm nodule still, but no redness / edema.
Patient reports bruising and soreness several days after the vaccine.  Then the area became dark and a red ring formed. Then the skin started to peel around the area.  It has now been 4 weeks, and the dark red skin has gotten better, but the skin was still peeling. It looked like it was healing though.
1 of 2 teenagers vaxed from same lot# who exp a sz immed following vax;prior to sz, felt lightheaded & fainted;placed on MD's table-arms & legs were twitching, eyes fixed;afterwards fine;observed 30 mins;no tx;no h/o szs;
Patient received both doses of pfizer vaccine in January and tested positive for covid 5/3/21
When giving ROTATEQ vaccine child projectile vomited every time attempt was made to give vaccine.
Nov 1, 2005 begin to develop soreness in right knee, ankle, foot, wrist, elbow and shoulder. Progressed with swelling and inability of full use of joints
Fever and fussy since 11 PM on 6-3-13. Temp of 103.6 on 6-4-13 at 6:45 AM.
Receive immunization 3/25/04. Woke up in middle of the night vomiting and tem 101. Used Motrin. No further vomiting.
I took my daughter to get the Pfizer 5-11 booster shot. I had called the clinic ahead of time to confirm that they have the Pfizer 5-11 booster available, and confirmed at check-in when I filled out the paperwork. The nurse administered a Moderna dosage for 6 month to 5 years, and realized her mistake only after giving the shots while she was filling out the vaccination record card. Two staff members there including the nurse assured me that it is still safe but feel uncomfortable because this is not the proper protocol and dosage.   NOTE: I also reported this same incident for my daughter (VAERS E-Report Number 882663). I think I made a mistake in reporting Facility as a public clinic--I think it's an urgent care facility, not sure. Also, the address provided is for the clinic but the vaccination site was set up next door at the Church.
Ten days after the above vaccine, I broke out with shingles.  I have never had shingles.  I received medical treatment on June 16th.  My doctor indicated that the vaccine played a part in compromising my immune system, and thus was a factor in the shingles breakout.
Fever started 7hrs after vaccine administration, rising above 102 degrees. Fever lasted 24 hours from onset of fever. Per Dr, we tried lukewarm baths, skin to skin, tylenol, and damp cloth on babys forehead.
01/03/22 presents to EC ED for "vascular access problem". PMHx of "ESRD on peritoneal dialysis, Hypertension, HLD, Anemia"
This spontaneous report as received from a nurse refers to her daughter who is female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with rubella vaccine (manufacturer unknown) (This case is created for M-M-R II) since Merck product could not be ruled out). On an unknown date, the patient had titers drawn for rubella (manufacturer unknown) for nursing program and result was negative despite having being vaccinated for it during the childhood. The outcome of event and causality assessment was not reported. The patient was vaccinated with varicella vaccine (manufacturer unknown) during childhood and experienced chickenpox (Reported in MARRS # 1611USA009929) and patient also showed negative titers for hepatitis B (manufacturer unknown) (reported in MARRS # 1611USA009931). Subsequently, the patient was vaccinated with GARDASIL and experienced adverse events (reported in MARRS # 1611USA008442). Additional information has been requested.
Pt woke in the morning stating her eyes were swollen shut and face was swollen. No itching, no SOB, rash to face and chest.
This literature marketed information has been received from a published literature article and refers to a 4-year-old boy who reported skin test positive pork allergy, no reports of other meat or alpha-gal allergy, no reported sIgE titers. The patient on an unspecified date in 2016, was diagnosed by the physician with anaphylaxis after vaccination with M-M-R II vaccination date, (dose, route, vaccination site, lot# and expiration date were not provided) and VARIVAX (vaccination date, dose, route, vaccination site, lot# and expiration date were not provided), for prophylaxis. Concomitant vaccines included poliovirus vaccine inactivated (unspecified), diphtheria toxoid, pertussis acellular vaccine (unspecified) and tetanus toxoid and influenza virus vaccine. At the time of reporting, the outcome of anaphylactic reaction was not reported. The author considered the event as a reaction associated to M-M-R II and VARIVAX. Upon internal review, anaphylactic reaction was determined to be medically significant. This is one of several reports from the same reporter Case # US-009507513-1809USA011156, US-009507513-1809USA012060, US-009507513-1809USA012067, US-009507513-1809USA012063, US-009507513-1809USA012064, US-009507513-1809USA012066, US-009507513-1809USA012062).; Sender's Comments: US-009507513-1809USA011156:
Severe back pain during the menstrual period. I always have back pain during the period but is always bearable. This time I am experiencing worse pain than I have ever experienced during perios.
FLU vaccine administered to client per  RN to left deltoid.  About 15 min after injection, client complaining of "severe itching" at site.  Redness and swelling also noted at site.  Client denies  shortness of breath, headache, or any other complaints.  Children's Liquid Benadryl 10ml given perRn to client.  Client refused adult dose.  Client stated "itching", along with redness had resolved about 15 after taking Benadryl.  No other complaints voiced.
Within 2 days of influenza high dose vaccine I experienced nasal and chest congestion, post nasal drip, severe cough. After 5 days and nights I went to E.R. had x ray to find I had pneumonia. RX Zpack for 5 days Also-severe bruise (L) arm upper.
Patient did not have any reactions post vaccination. Patient was seen By Dr on 02/01/22 , the patients parent was notified of this medication error at the time of his appointment.
This spontaneous report as received from a healthcare worker refers to a 24 year old female patient. Pertinent medical history, drug reactions or allergies were unspecified. On 13-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 "1 shot", lot # K004542, expiration date 19-AUG-2015, (dose, dose number, route, anatomical location were unspecified). Concomitant therapies were not reported. On 15-OCT-2014 the patient experienced cellulitis. The patient sought medical attention (unspecified). The patient received an unspecified antibiotic for the treatment of the cellulitis. The outcome of cellulitis was reported as recovering. The relatedness between cellulitis and PNEUMOVAX 23 was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report based on information received by Pfizer from Merck & Co., Inc. (Case Number: 00614407). A contactable physician via Merck field representative reported that a patient of unspecified age, ethnicity, and gender received PREVNAR 13, (lot number and expiration date unknown), via an unspecified route of administration in the arm on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that on an unspecified date, the patient's arm, "completely blew up in a rash" after receiving an injection of the pneumococcal 13-valent conjugate vaccine. The outcome of the event was unknown.
After each vaccine felt flushed heart racing felt dizzy, The booster vaccine was the worst my heart rate was in 170?s for about two hours. I felt like I was going to pass out I was pale. Dizzy, nauseous. I felt horrible.
"Irregular" epileptic seizure in patient with previous history of medication-controlled epilepsy.
Arm pain, not being able to raise arm over shoulder, tried some Aleve with minimal relief. Scheduled follow-up appointment with PCP
I feel like it's inflamed; yesterday I was very uncomfortable because I had a full meal after a long time; when I eat something, it burns; when I eat something, it hurts; c-section scar was burning and hurting; I felt some cramps; I did not pass stool for a week; my heart rate dropped for a whole week after getting the shot; I've lost 12 lbs since taking shot since I can't eat much; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (I felt some cramps), BOWEL MOVEMENT IRREGULARITY (I did not pass stool for a week), DYSPEPSIA (when I eat something, it burns), ABDOMINAL PAIN UPPER (when I eat something, it hurts) and SCAR PAIN (c-section scar was burning and hurting) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced MUSCLE SPASMS (I felt some cramps), BOWEL MOVEMENT IRREGULARITY (I did not pass stool for a week), WEIGHT DECREASED (I've lost 12 lbs since taking shot since I can't eat much) and HEART RATE DECREASED (my heart rate dropped for a whole week after getting the shot). On 03-Aug-2021, the patient experienced DYSPEPSIA (when I eat something, it burns), ABDOMINAL PAIN UPPER (when I eat something, it hurts) and SCAR PAIN (c-section scar was burning and hurting). On 15-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (yesterday I was very uncomfortable because I had a full meal after a long time). On an unknown date, the patient experienced SCAR INFLAMMATION (I feel like it's inflamed). The patient was treated with MACROGOL 3350 (MIRALAX) for Bowel movement irregularity, at a dose of 1 dosage form and PROBIOTICS NOS at a dose of 1 dosage form. At the time of the report, MUSCLE SPASMS (I felt some cramps), BOWEL MOVEMENT IRREGULARITY (I did not pass stool for a week), DYSPEPSIA (when I eat something, it burns), ABDOMINAL PAIN UPPER (when I eat something, it hurts), SCAR PAIN (c-section scar was burning and hurting), SCAR INFLAMMATION (I feel like it's inflamed), WEIGHT DECREASED (I've lost 12 lbs since taking shot since I can't eat much), ABDOMINAL DISCOMFORT (yesterday I was very uncomfortable because I had a full meal after a long time) and HEART RATE DECREASED (my heart rate dropped for a whole week after getting the shot) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicine included colon cleanser for natural bowel movements.   This case was linked to US-MODERNATX, INC.-MOD-2021-287626 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-287626:same reporter
Singles / rash on lower back and left leg. Shooting pains and soreness down left side. Throbbing pain behind rash on knee.
Lump in arm, headache, fever 101 for 2 days. Back and neck aches. Fatigue for 5 days. Arm red, swollen and inflamed and sore. Follow up 8/26/02. Patient complained of small, painless lump size of marble. No other symptoms.
Headache; Muscle aches; Swelling at the injection site; feeling awful; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received the 2nd dose of Shingrix. On 3rd December 2019, 1 days after receiving Shingrix, the patient experienced headache, myalgia, injection site swelling and feels awful. The patient was treated with nsaid's (Nsaid). On an unknown date, the outcome of the headache, myalgia, injection site swelling and feels awful were unknown.   It was unknown if the reporter considered the headache, myalgia, injection site swelling and feels awful to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided. The age group was not reported but was selected as adult as per vaccine indication.  After receiving second shot of shingles on next day the patient experienced headache, myalgia, injection site swelling and feels awful. The patient ask to reporter that how long do these symptoms usually last. On reporting date the patient take NSAID . The reporter is not a health care professional.
Pt became diaphoretic, light headed at 4:51p. Per EMT BP  106/60, HR 86, O2 sat 96, blood sugar 68. Pt given apple juice. Pt stated he had not eaten yet today. Pt given graham crackers and another apple juice. He felt much better. Pt will stop to get something more to eat on his way home. Patient wanted to leave at 5:12.
In May after receiving dose 2, I started to get my usual PMS symptoms. I noticed that more and usual I was have a lot of breast pain, my lymph nodes swelled and my breast became swollen. My period has now been 3 days of very heavy flow with extreme pain and cramping. My breast are still swollen and painful, the lymph nodes under my arms are still swollen and painful. I also noticed that I was getting symptoms of IBS type symptoms. My cycle now is pretty usual, I say it back to normal, the unusual cycle lasted for about three cycles after my vaccine.
This spontaneous report as received from a pharmacist refers to an elderly 68 year-old male patient with no pertinent medical history, concomitant medications or known drug reactions and allergies. On 28-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 intramuscularly in the right deltoid (exact dose, dose number were not reported; lot # M015418 with the expiration date of 12-OCT-2017) for prophylaxis. On 29-SEP-2017, the patient developed redness and swelling in his right arm. No treatment was given and the events resolved "on its own" on 01-OCT-2017. No lab diagnostic studies were performed. The causality assessment between the events and PNEUMOVAX 23 was not provided.
Dose 1:  sore upper arm (3 days) Dose 2:  sore upper arm (3 days), chills (6 pm 3/31 to midnight 3/31), fever (midnight 3/31 - noon 4/1 ), sinus headache (10am 4/1 to 2pm 4/1)), fatigue (8pm 3/31 to 9am 4/3), cough (6 hrs 4/2 afternoon and evening), upset stomach (on and off 4/1 to 4/4).  Took no OTC medication for either dose.
dizziness; arm got sore; persistent headaches; hardness; fatigue; where I got the injection is pinkish red; body aches; swollen; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PAIN IN EXTREMITY (arm got sore), HEADACHE (persistent headaches), INDURATION (hardness) and FATIGUE (fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (dizziness), PAIN IN EXTREMITY (arm got sore), HEADACHE (persistent headaches), INDURATION (hardness), FATIGUE (fatigue), ERYTHEMA (where I got the injection is pinkish red), MYALGIA (body aches) and SWELLING (swollen). The patient was treated with IBUPROFEN ongoing since an unknown date for Headache, Myalgia and Fatigue, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), PAIN IN EXTREMITY (arm got sore), HEADACHE (persistent headaches), INDURATION (hardness), FATIGUE (fatigue), ERYTHEMA (where I got the injection is pinkish red), MYALGIA (body aches) and SWELLING (swollen) outcome was unknown. 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.   Concomitant medication use was unknown
Onset of Guillain-Barré syndrome.  Admitted and still inpatient in the hospital being treated. Admitted to the hospital 4/7/2021
Mom took child to ER on 12/20/07 due to (R) leg being red, swollen, and warm. Diagnosed with cellulitis per mom. Give antibiotics via shot and sent home and told to see primary doctor. Also prescribed abx.
Nausea; dizziness; tired; This is a spontaneous report from a contactable other HCP (reported for herself). A 37-year-old not pregnant female patient received first dose of BNT162B2 (solution for injection, Lot number: EL3302, Expiry date: unknown) via an unspecified route of administration in left arm on 26Jan2021 03:00 PM, as a first dose, single for Covid-19 immunization. Medical history included Hashimotos Thyroiditis. She had known allergies: Vicodin, Keflex. Concomitant medications in two weeks included levothyroxine sodium (SYNTHROID). On 27Jan2021 12:00 PM, the patient experienced nausea, dizziness and tired. She did not receive treatment for events. She had no other vaccine in four weeks. She did not have covid prior vaccination and was not tested for it post vaccination. On an unknown date, the patient recovered from the events of nausea, dizziness and tired.  Follow-up attempts were completed. No further information was expected.
At 1pm on January 6th I became fatigued and had a low grade fever of 99.1
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 61 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: FM0698), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: ER8730), on 17Apr2021 as dose 2, single (Lot number: EW0153), in left arm and as dose 3 (booster), single (Lot number: 30155BA), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure and covid-19 with Paxlovid from 25Mar2023 to 29Mar2023.
Vaccine administered beyond the  6 hour limit after reconstitution. Patient reported sore arm. Contacted Pfizer which recommended administer vaccine again.
Rt side body swelling. Rt eye swelled shut. Hearing loss Rt. ear. Headache