chrisvoncsefalvay/vaers-outcomes huggingface dataset:
little red bumps/ hand over her wrists, you could feel the bumps; Minor rash on back of her hand and wrists; This is a spontaneous report from a contactable consumer (patient, self-reported). A 69-year-old female patient (age at vaccination: 69 year) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9262 and expiry date was not reported), via an unspecified route of administration, in Deltoid Right (upper arm), on 30Jan2021, as a single dose for COVID-19 immunization. The patient's medical history included ongoing lymphoma and leukemia from Jul2018 and fungal lung infection, valley fever, coccidioidomycosis from Sep2020 (Stated she was still taking medicine, it can take over a year for fungus to go away, it is very recalcitrant). Concomitant medications were not reported. The patient reported that she got blood work regularly (unknown result). The patient reported that she got the COVID 19 vaccine, first one on 30Jan2021, at the (Vaccine facility name), afterwards she had a minor rash on wrists, they kept her for an hour to observe, she had no other symptoms, just the rash, it didn't itch, it was slightly on the back of her hand and wrists, and they said if she got the second dose, the reaction could be more severe, she didn't know to get it and take the risk, she was almost 70, and was cautious about being 55% protected with one dose. She talked to her doctor and was told it was up to her. She was calling to ask, it said in the handout, if you have severe allergic reactions you shouldn't, but this wasn't severe, it was mild, a localized rash on both wrists, and she wanted to get the second, she did have other health problems. She went through the clinic, it took a half hour, and she got out to the truck and was going to put on hand sanitizer but didn't, she noticed the rash on her wrists and went back in and told them, they kept her another hour, took her blood pressure, oxygen and what not, and she was fine, had no symptoms, and they said the county may not give her another vaccine, if she got the second she could have a more severe allergic reaction. She was trying to weigh the risk of being about 50% protected versus a severe reaction. There was a hospital about 3 blocks away from the clinic. The rash went away, she was fine now, she had it Saturday, Sunday, into Monday, it went away Tuesday, it was slightly up the back of her hand and both wrists, little red bumps, she didn't itch or anything, but if you ran your hand over her wrists, you could feel the bumps. Vaccine card said to get second dose by 20Feb2021, 3 weeks later. Outcome of the event minor rash on back of her hand and wrists was recovered on 02Feb2021 and for another event, it was unknown.  Follow-up attempts are completed. No further information is expected.
About 2/3 days after, I have é be feeling dizzy/ vertigo when laying down or quickly getting out of bed for about 2 weeks now   I?m not sure if this is a side-effect from the vaccine but this feeling is new to me and my doctor suggested I report it in case there are others who feel this way.
This spontaneous report was received from a pharmacist concerning a 50 year old female patient with sulfa allergy. On 24-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose number not reported) lot # K003597, expiration date 12-MAR-2015, 0.65 ml, subcutaneous in the left arm. Historical drug included sulfa. Patient was not on concomitant therapies at the time of the report. The pharmacist reported that when the patient awakened on 25-SEP-2014 (reported as yesterday), experiencing a headache, for which she took TYLENOL. The pharmacist stated that when the patient was preparing for work on 26-SEP-2014 (reported as today), she felt "itchy all over (her) body". The pharmacist reported that when the patient was putting on her deodorant, she noticed that her left armpit was painful. Then noticed that her left deltoid region, where she received her dose of ZOSTAVAX, was red in a 6 cm by 4 cm area. The injection site area was warm, but not swollen. On 26-SEP-2014, the outcome was reported as recovered (reported as she was not in any distress). Patient did not seek for medical attention or performed any lab diagnostics studies. Additional information has been requested.
Information has been received from a certified medical assistant concerning a 53 year old female patient with diabetes, seizure disorder, chronic fatigue syndrome, DEPAKOTE, DILANTIN and PROVIGIL; who on 08-SEP-2008 was vaccinated intramuscularly with one dose of PNEUMOVAX (Lot # 660717/0224X). Subsequently, the patient experienced an injection site reaction. The area was swollen, red and painful. The patient sought medical attention. On an unspecified date, the patient had recovered. This is one of two cases from the same source. Additional information has been requested.
Pt started with chills and sore throat approximately 12 hours after receiving the vaccines.  She presented to urgent care on 10/7/21 and was seen.  The urgent care did a rapid strep which was negative and advised to due symptomatic treatment.  They felt she was experiencing an immune response the vaccines.
Narrative:  Patient received Pfizer vaccine 1st dose. Approximately 5 minutes after vaccine administration patient reported being "thirsty" was able to ambulate by self and then patient then fell forward after sitting down in a chair in the vaccine monitor room. Patient reports feeling nauseous, tired, hot, and reports thinking he blacked out. Patient had vital signs taken 140/69, 89 HR, 97% RA, 20 R, and denies pain. A rapid response was called and patient was escorted to ER by RN.
Arm pain is primary symptom. Vasovagal syncope the following morning due to continued pain.
PATIENT COMPLAINED OF SWELLING, REDNESS AROUND INJECTION SIGHT AND FEELING NAUSEATED. SAID ARM HAD SWELLED UP TO ABOUT SIZE OF 2 GOLF BALLS WITHIN COUPLE DAYS OF VACCINATION. SHE NOTICED IT IN MORNING AFTER SHOT AND IT CONTINUED TO GET WORSE. PAINFUL ONLY IF TOUCHED.
Burning/tingling pain on eyebrow, over the course of three weeks burning stinging sensation moved to cover left side of face, left eyeball, and arm. Painful. No visible rash.
Client (3 year old child) was thrashing and kicking while RN attempted to administer six different vaccines. Mother attempted to hold child, but mother moved suddenly right before the Prevnar 13 was administered. Nurse administered the Prevnar 13 into child's RVL and realized then that it had grazed (superficially penetrated) the mother's skin in her right pectoral area, but not been injected into the area before it penetrated client's right vastus lateralis muscle . Mother of child reported no signs, symptoms, discomfort, pain at the time of the event. Client (her child) did receive full dose of the Prevnar 13 in her right vastus lateralis muscle.  Five days later, Nurse called mother of child on 06/16/2021 at 0830 am to check on her. Mother of child reported to the nurse that she had no signs, symptoms, discomfort or pain in her right pectoral area. She also reported that the client, her three-year-old daughter, was not showing any symptoms of irritation, pain, swelling or discomfort in her right vastus lateralis area.
Child received two vaccines on 4/15/05. IPV 4 was given at left thigh 0.5cc IM, DTaP 5 was given at right thigh 0.5cc IM. Child's left thigh became swollen and inflamed approximately 4-5 hrs later with c/o pain and fever. Fever was 101F, on 4/16 and 4/17, states mother. Mother phoned clinic on 4/22 and 4/25 with report of vaccine site redness. Child taking OTC Tylenol prn, Child seen by MD at our clinic on 4/26/05.
Four days after vaccine pt noticed a rash on her upper left arm. Itchy,red, painful to touch. "Looks like a bee sting." Getting flu-like symptoms. Hoarse voice, tired, sneezing, sleeping a lot.  So tired while driving and had to pull off the road to take a nap. Hive measures 38mm
Severe neck pain for over a month.  Inflammation in throat and joints.  Shortness of breath.  Ongoing  for 30+ days
Swelling; redness; fatigue; fever 101.7 for 48 hours.
Full body paresthesia; This case was reported by a physician via sales rep and described the occurrence of paresthesia generalized in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced paresthesia generalized. Shingrix was discontinued. On an unknown date, the outcome of the paresthesia generalized was recovered/resolved.   It was unknown if the reporter considered the paresthesia generalized to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported but it could be 79 years or 80 years. Approximately 4 months before the date of reporting, in 2019, the patient received Shingrix. The patient experienced full body paresthesia which lasted about 2 days. The patient was fully recovered but refused to receive 2nd dose. The reporter denied for follow up contact.
blurry vision on both eyes; This is a spontaneous report from a contactable consumer (Caller reported for grandson) or other non-Healthcare Professional (HCP). A 19-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. In two weeks, the patient experienced blurry vision on both eyes on an unspecified date and was hospitalized. It was reported that the patient would be getting the second dose and will be back on campus and they are making him quarantine and get tested every week. He was still having this issue up until today (as reported). They have been to the doctor. The patient underwent lab tests and procedures which included computerised tomogram: unknown results, lab test (investigation): unknown results, magnetic resonance imaging: unknown results. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Dizziness, mild. Started 1 week after second covid shot, barely noticeable in the mornings when I got up or sometimes when I moved my head while sitting for long periods at my desk.  Today, 16 days after second shot, dizziness is mild, but constant.
17JUN98 chills, pale, malaise, tired;stayed in bed 17JUN, 18JUN up for a while on 19JUN;felt better on 20JUN98;stated lt arm swollen from lt shoulder to elbow lt arm also sore & hard to touch;some redness @ back of arm;
Body aches, severe headache, chills, uncontrollable shaking, sweating, nausea, vomiting. Phoned for advice, no fever, so no intervention. No prior reactions to annual flu shots, incl high dose type. Symptoms gradually resolved in about 12 hours.
Patient received vaccinations of Hep A and Varicella after screening for contraindications. Her mother stated, "My daughter is having a seizure." I went over to the patient and witnessed that her arms were contracted and shaking. Her mother stated,  "her eyes were open and staring." The seizure lasted for one minute. Mother reported , "No history of seizures." Patient was alert, oriented to time, place and person. Patient asked to go to the bathroom. She had a steady gait and was able to urinate. She returned to the clinic room. I helped her on the bench, elevated her legs, and Dr. examined her. HR 90 regular, BP was 102/60, skin was pale, dry with red patches on face. After 5 minutes she was able to get up and sit in chair. About 5 minutes later, patient was not responding to verbal commands. Placed her on the bench, elevated legs. EMS called, but did not transport. Parents took her to the ER and pediatrician. Dx was a vagal response to vaccination.
Could not lift arm that night, tried to keep moving it, iced it, seemed to worsen, hot water bottle, ADVIL. helped, very sore for about 3 days, hardly could move it. Told nurse on 9/21/15. Use BIO FREEZE and wraps for work days. 10-14-15 finally felt better. Started physical therapy (work) 10-13-15 electrode pads, achiness is better. As of 10017-15 not 100% very 95% better. Shot was given high on right arm - higher than in previous years.
2 patients received first dose of the Covid-19 Vaccine and then contracted Covid-19.; 2 patients received first dose of the Covid-19 Vaccine and then contracted Covid-19.; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. This consumer reported similar events for two patients. This is first of two reports. A patient of unspecified age and gender received first dose Covid-19 Vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history includes patients were exposed to the virus. The patient's concomitant medications were not reported. The patient received first dose of the covid-19 vaccine and then contracted covid-19. Caller stated it is not an AE since her patients were exposed to the virus. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021085847 Same reporter/ drug/ event for different patients.
patient given Moderna for 2nd dose instead of Pfizer due to miscommunication at vaccination site
Patient complains of redness and erythema absent of swelling in his right bicep, but not in the immediate area of the PNEUMOVAX 23 injection site. I checked back with patient about 1.5 hours after recommending dose of diphenhydramine and acetaminophen, and was told by patient's spouse it seemed to have improved (patient had gone on to bed for the night).
Breakthrough case admission after 4 vaccines Moderna 2/4/21 Lot# 007M20A ; Moderna 3/6/21 Lot# 015M20A;  MOderna 10/30/21 Lot# 039F21A;  MOderna 11/5/22 Lot# 016H22A
Patient stated a itchy red, rash has developed at the site of the injection site, about the size of the palm of her hand.
After receiving vaccinations on 3/2/11, child broke out in head to toe red rash on 3/4/11. Temperature of 102.7. Child taken to Hospital emergency room. Mother stated physician diagnosed allergic reaction to vaccines. Given course of Prednisone. No difficulty breathing. Rash itchy and red. Child recuperating at home.
Patient received TDaP injection to left deltoid 6/9/09. On 6/11/09 patient called clinic to complain of n/v during the 24h following immunization and development of left breast tenderness. N/V subsided but breast redness and tenderness worsened, for which patient was seen in clinic for evaluation. Patient was referred to local ER for cellulitis, resulting in hospitalization from 6/12 thru 6/16 for IV antibiotic therapy.  7/23/09 Hospital outpatient records received DOS 6/12/09 to 7/8/09. Assessment: Cellulitis of left chest, left breast, and left arm. Patient presents with entire left breast bright firely red. Tenderness around areola and below it.  Areas above and below breast are hyperemic and urticarial. Tenderness in lymph node under left axilla. Redness extends into upper shoulder. No area of redness at immunization site. Patient sent to non-VA hospital. Hospitalized from 6/12/09 to 6/16/09. Patient presents for follow-up for a cellulitis of the left chest wall including the left breast and left arm, major depression, and vitamin D deficiency. Rash left breast, itching. Zoloft associated diarrhea.
my mom, who also took 2 Pfizer COVID shots; my mom has A-fib; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "my mom, who also took 2 Pfizer COVID shots; my mom has A-fib".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lightheaded, dizziness, feeling warm BP 137/89 HR 101 Sp02; 99% seen and cleared by EMS
At the IPV injection site, it is large (currently the size of an orange), red and swollen. The injection site is warm to the touch and my daughter is complaining that it itches and is sore to the touch.
Patient complained of sore arm and diarrhea for several days after vaccination.  Side effects reported on 12/12/22, 1 week after the vaccine was administered.
This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine leaked during administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00170848) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine leaked during administration). At the time of the report, ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine leaked during administration) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were reported. No Treatment medications were reported. Action taken with mRNA-1273 in response to the events were Not Applicable.
Symptoms: Fever, Sweating, Nauseas, Swelling/redness at vaccination site in as large as a pancake. Severe pain left arm at vaccination site, severe pain entire arm including left hand, left side of neck and left shoulder blade. Stiffness, limited movement. Symptoms continue all week and remain unchanged on 5/13/2011 at 7:18 pm. Went back to Doctor on Wed, 5/11. He prescribed Amoxicillin 500 MG 3 times a day. Oxycodone-Acetaminophen 5-325 - 1 to tablets every six hours as needed for pain. Advil caps as needed. Allergy tablets as needed. Ice packs on left arm/shoulder area. Have not yet recovered from adverse reaction. Took time off from Work on Wed, Thurs and Fri (May 11-13) for excessive pain, limited movement left arm.
Patient stated her "throat felt itchy" approximately 1 minute after injection, asked the patient if she would take an antihistamine, she agreed and took 2 Diphenhydramine 25mg tablets by mouth. Over 15 minutes later the patient insisted she was fine that she "would know if it was going to get worse".  Patient did not have any rash or swelling at injection site, nor did she have any rash or swelling any other location.  Called patient over 3 hours later at home her husband stated she was napping but that she was great.
it was red and itching; there was a lump there; it was red and itching; developed this terrible rash; the lymph nodes under my arm were swollen; left arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (it was red and itching), MASS (there was a lump there), ERYTHEMA (it was red and itching), VACCINATION SITE PAIN (left arm was very sore) and RASH (developed this terrible rash) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (left arm was very sore). On 19-Feb-2021, the patient experienced PRURITUS (it was red and itching), MASS (there was a lump there), ERYTHEMA (it was red and itching), RASH (developed this terrible rash) and LYMPHADENOPATHY (the lymph nodes under my arm were swollen). On 11-Feb-2021, VACCINATION SITE PAIN (left arm was very sore) had resolved. On 21-Feb-2021, PRURITUS (it was red and itching), MASS (there was a lump there), ERYTHEMA (it was red and itching), RASH (developed this terrible rash) and LYMPHADENOPATHY (the lymph nodes under my arm were swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four residents of nursing facility received expired doses of vaccine FLUZONE HIGH DOSE (expiration date: April 2018, batch number, dose, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used (four residents of nursing facility received expired doses of Fluzone High dose). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Approx 20 hours after receiving this vaccine I began to have chills as well as muscle aches all over my body. Several times throughout the following 12-18 hours I was having heart palpitations and back spasms as well as some accompanying shortness of breathe.
Immediately following shot, got very hot, sweating and dizzy. Ears started ringing and started passing out. I threw up and then got some help and laid down.
Swelling of upper right arm with swollen lumphs in axilla began 12 hours after injection. Temp 101.2.
Had the vaccine at 11:40 am, started headache around 9 pm that night. Went to bed, had fever, chills, shaking all over, terrible joint and muscle aches and pains, headache, nausea, couldn't sleep. Injection site was and still is very swollen, red, itchy.  Still sick the next day, Friday, March 12th and Saturday March 13th. Had bouts of diarrhea on Saturday evening. Cramping, nausea. Slightly better Sunday March 14th, but still extremely tired and achey.  Today, Monday, March 15th I am able to sit up and function finally. Not as much nausea, no cramping, only slightly achey.  I had Covid July 2020 and this reaction, etc was worse than the covid experience!! Not sure I want to get my second vaccine.