chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hot, red, swollen, hard. The parent noticed the next morning 12/15/04. MD gave him an antibiotic and antihistamine. Keflex and Decodron.
Pt came in with mom for a flu. She was checked in with normal temp of 98. Potential SE from Flu shot was explained to pt and her mom, including injection site irritation and fever. Also informed what to do in event of these SE occurring. Prior to immunization given, pt seems nervous and anxious. Flu shot was given around 1pm. I, Rph, gave her the shot following the normal protocol and proper injection technique. Immediately following the shot she said it stung at the injection site. Notified her that it was normal and to ice it if it gets swollen or irritated more. Also informed pt's party to let us know if anything else. Pt was snapping at her mom stating that she really needed to eat. She was quite inpatient about getting something to eat. After confirming all questions answered and I walked away from the pt and into the pharmacy. Within a few seconds, I heard a loud yelling, but didn't hear what was said. Initially, I was under the impression that mom and daughter were fighting since pt, the daughter, had been rude to her mom before and after the injection. Then I started to hear "HELP, HELP, she's having a seizure." I ran outside immediately with an epinephrine pen to assess pt. Upon getting to her, she came back to be awake and alert, but seemed very pale. I did not witness what has happened since it was over by the time I got there. Mom and I agree that it probably only lasted for 10-15 seconds. Mom described event to be where she started shaking with her arms crossed in a locked position. Her body was stiff and went into seizure. Again, by the time I came back out, pt was awake and alert already, but didn't remember what had happened. I measure her temperature again and it measured 95 degrees. Gave her some water and chocolate per pt's request as she continued to complain that she wanted to get out to go eat. She also stated that she felt hot and sweaty. In the meantime, as soon as my tech saw me run to pt, he called 911 and they got to us within about 5 minutes. They assessed her and took her to ER. We were informed that her BP and HR was low. In my opinion, this event is unlikely to be a direct consequence of flu shot side effect or injection technique error. I believe that pt may have had other conditions, physical or mental, pre-existing prior to the shot given and her getting the shot escalated the condition to lead to her having a possible syncope or seizure episode. The mom was here during the whole event. She has been communicated as stated above of potential SE from Flu shot and what is to be expected. Took necessary actions following event to make sure pt was taken care of and assisted EMT in providing them with all necessary information. Pt was taken to ER with mom. Mom was informed of my name and asked mom to give us a call if needing anything else and to let us know what happens. Mom was also informed that we are filing a report. Called Risk Management team and opened up a case.
I was vaccinated at 9am on 1/25/2021.  I had no noticeable side effects that day.  At approximately 1:00 a.m. on 1/26/2021 I started waking up a lot and couldn't get comfortable.  I tossed and turned and body aches began and quickly worsened.  My knees, thigh bones, hips, pelvis, lower back, and shoulders all hurt like I had been beaten with a bat.  I took a sick day from work due to the severity of symptoms.  I had no fever, but did have hot flashes periodically throughout the day.  I was dizzy upon standing, had nasal congestion, and sever fatigue, and developed a moderately bad headache later that day.  I went to sleep at 10:30 p.m. on 1/26/2021 and slept through the night.  Upon waking on 1/27/2021, I felt much better.  I still have some lingering fatigue and stiffness but not enough to interfere with my normal routine.  I was vaccinated in my left arm and today, 1/27/2021 I woke up with swollen lymph nodes in my left armpit that are quite sore.
I waited for the second shot and received July 21, exactly three weeks later August 11, I found a lump in my left breast. Going through the motions of a mammogram, scans, biopsys, I was diagnosed with stage 2-3 breast cancer with no family history, no cancer genes etc.  Within a month the tumor had grown from the single lump I found to three separate tumors and I have since undergone a full mastectomy on the left side.  The vaccine promotes and causes cancer.  Also, two months in a row I have faced heavy period blooding, down my legs which I have never in my life had issues or challenges with heavy bleeding.
This spontaneous report as received from a health professional refers to a 4 year old patient. On 29-JUL-2014 the patient was vaccinated with a dose of M-M-R II (HS, lot # K000174, EXP date: 11-JUN-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Pt developed a blistery rash on the chest 5 days after the vaccine. It started on 10/21/2022 at night. Described them as 10-12 pimples grouped together on chest, 1 blister on palm of hand, a few on the chin and neck areas as well. The pt has not changed laundry detergent, soap, perfume and did not eat anything unusual. Pt asked whether you can get shingles after being vaccinated with the shingles shot. I explained that infection with shingles is still a possibility even after being vaccinated for it. The rash/pimples are not painful. I suggested trying benadryl and contacting her primary Dr. to follow-up. She will be calling the Dr on Monday.
States last evening suddenly felt like throat was closing up, difficulty breathing and swollen eyes.  Episode lasted approximately 3-4 hours.  Today, 12 hours later, her eyes are still somewhat puffy but no other problems.  Did not seek medical attention but did take some Benedryl.
runny nose; some post nasal drip; ache; headache; dry occ. cough; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 58-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscularly at site of left arm at 08:15 on 19Dec2020 at single dose for COVID-19 immunization. Medical history included breast cancer from 2017. Concomitant medication included atorvastatin and exemestane. The patient previously took aspirin and experienced allergies: aspirin. The patient started with dry occ. Cough at 9:00 on 23Dec2020, with aches and headache, no fever on 24Dec2020, with some postnasal drip, runny nose and aches, no fever on 25Dec2020. The patient received paracetamol (TYLENOL) for treatment. The event still here but slightly improved. Reporter would assume they were related to the vaccine but she wanted to be sure because if they started like three days later and she had the aches and things, that could be COVID related, the aches and the headache but also could be vaccine related. The outcome of event was recovering.
body aches; mild itching; fatigue; coughing; Initial information received on 14-Nov-2023 regarding an unsolicited valid non-serious case received from a Patient.  This case is linked to case 2023SA357652(Same Patient).  This case involves a 73 years old male patient who experienced body aches, mild itching, fatigue and coughing after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Oct-2023, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation.  On 08-Oct-2023 the patient developed body aches (pain), mild itching (pruritus), fatigue and coughing (cough) (latency- 7 days) following the administration of influenza vaccine.  Action taken- not applicable.  The patient was treated with dexamethasone for Pruritus.  At time of reporting, the outcome was Unknown for all the events.
COVID-19; COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "sjogrens" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Feb2023) Negative, notes: After initial 5 days of doses Paxlovid I tested negative; (16Feb2023) Positive, notes: 7days after completion have retested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10Feb2023 to 15Feb2023.  Clinical course: The patient is on therapy with heart medications from 01Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax; became unresponsive for 1-2 sec; starting crying instantly; observed baby for 20 min;
Patient was administered Pfizer Covid vaccine and within a few minutes, tongue became numb. Patient administered benadryl and made to wait in the IMZ area for 30 extra minutes.  Reaction did not resolve, but did not progress.
48 hours later moderate to severe facial swelling, erethema,  worsening over 2 more days slowly subsiding after day 3 of benadryl
Gray dot on thigh; 1st dose: 18-JAN-2022; This case was reported by a nurse and described the occurrence of skin discoloration in a patient who received Hib (Hiberix) (batch number 25N39, expiry date unknown) for prophylaxis.   On 18th January 2022, the patient received the 1st dose of Hiberix. On 18th January 2022, unknown after receiving Hiberix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the skin discoloration to be related to Hiberix.     Linked case(s) involving the same patient:  US2022AMR171197, US2022AMR171230   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comment: he reporter reported that the patient after received Hiberix and experienced gray dot on the legs. The patient received Hiberix vaccine on the day of birth. Additional supportive information: The patient received Hiberix who was younger than the indicated age which led to inappropriate age at vaccine administration. This case had been linked with US2022AMR171197 and US2022AMR171230  by same reporter for same patient.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171062:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171169:Same reporter US-GSK-US2022AMR171197:Same reporter US-GSK-US2022AMR171230:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171169:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171197:Same reporter US-GSK-US2022AMR148961: US-GSK-US2022AMR149561: US-GSK-US2022AMR149560:
First few minutes after injection, had mild tingling and pain from left upper back to neck and up the left side of the back of my head.  Been experiencing moderate body aches specifically on my upper back, shoulders, neck and head. Headaches have been mild and comes and goes until today.  Woke up 9am with headache thats increasing in intensity.  Took 3 x 200mg Advil at 12:00pm but did not do much  to help with headache or body ache. Feeling nauseous and very fatigued.
itched; burned; tingled; This is a spontaneous report from a contactable Other HCP. A 42-years-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El0142, Expiration date:unknown), via an intramuscular in Right arm on 04Jan2021 07:30 as SINGLE DOSE and second dose received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261, Expiration date: unknown), via an unspecified route of administration in Right arm on 21Jan2021 at SINGLE DOSE for COVID-19 immunization. Patient medical history included known allergies: Sulfa, penicillin. Concomitant medication included Vitamin C (ascorbic acid), ZINC (zinc), ADVIL (ibuprofen). 10 days after the first dose, patient's toes started itching so bad. On 14Jan2021 07:00,  patient experienced itched, burned, and tingled. For 10 days feet itched, burned, tingled. Patient did not received treatment for the events.  Post to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of event was recovered.
normal activity is done, all she doing is eating and sleeping; feels wiped out; had a swollen arm; had a really bad reaction at first; have bruising,visible bruise; one time discolored the whole arm; still hard tissue about 4 inch about 2 and a half inches; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (normal activity is done, all she doing is eating and sleeping), ASTHENIA (feels wiped out), PERIPHERAL SWELLING (had a swollen arm), VACCINATION COMPLICATION (had a really bad reaction at first) and CONTUSION (have bruising,visible bruise) in an 83-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 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (normal activity is done, all she doing is eating and sleeping), ASTHENIA (feels wiped out), PERIPHERAL SWELLING (had a swollen arm), VACCINATION COMPLICATION (had a really bad reaction at first), CONTUSION (have bruising,visible bruise), SKIN DISCOLOURATION (one time discolored the whole arm) and INDURATION (still hard tissue about 4 inch about 2 and a half inches). At the time of the report, SOMNOLENCE (normal activity is done, all she doing is eating and sleeping), ASTHENIA (feels wiped out), PERIPHERAL SWELLING (had a swollen arm), VACCINATION COMPLICATION (had a really bad reaction at first), CONTUSION (have bruising,visible bruise), SKIN DISCOLOURATION (one time discolored the whole arm) and INDURATION (still hard tissue about 4 inch about 2 and a half inches) outcome was unknown.            No concomitant medications provided. No treatment medications provided.
This spontaneous report as received from a physician via a company representative refers to a female patient now in her 20's. The patient's current conditions or medical history were not reported. On an unspecified date, in the last year, the patient was vaccinated as adolescent with all 3 doses of GARDASIL (dose, route, lot number and expiration date were not reported). On an unspecified date, the patient was diagnosed with high risk HPV (human papilloma virus). The patient cleared the HPV without requiring treatment. The high risk HPV serotype was not determined. The patient went to the doctor's office for medical attention. Pap with HPV DNA testing were performed on an unspecified date, HPV serotype was not determined. This one of several reports from the same source. Additional information has been requested.
This case was reported by a pharmacist via sales rep and described the occurrence of general body pain in a 69-year-old patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020) for prophylaxis. Previously administered products included ZOSTAVAX (received on 17th July 2013). On 17th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, itchy upper limbs, rash, erythema of extremities, injection site erythema and injection site swelling. On an unknown date, the outcome of the general body pain, itchy upper limbs, rash, erythema of extremities, injection site erythema and injection site swelling were unknown. The reporter considered the general body pain, itchy upper limbs, rash, erythema of extremities, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported, however, it could be 68 or 69 years. The patient was a hospital employee. The rash was described as being on the whole arm. The red streaks were on the lower part of the upper arm to the elbow. The symptom of itching was of the arm. Concomitant medications, vaccination facility, and other specific details were unknown, as no further information was provided during the call. The reporter gave consent to be contacted for follow up information. This case was one of the 9 cases reported by the same reporter. The reporter stated over the phone that about half of the eight patients had experienced flu-like symptoms, one of which was another doctor who could not go to a work related event the next day because of the symptoms. It was unknown which of the eight patients was the concerned doctor.
Circular rash, 1 cm in circumference, redness, crusty, raised slightly, itchy.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Treatment information was not provided.    This case was linked to (Patient Link).
lip swelling, throat itching, facial flushing - sx started 3/29am. had gotten the vaccine first dose 3/18. had episode of pruritis and UE arm swelling recently also but a few days prior to covid vaccine.
Patient received vaccines, then approximately five minutes later reported feeling lightheaded. He sat down on bench then lost consciousness and slid off bench on to the floor. He regained consciousness almost immediately. He remained in pharmacy for another fifteen minutes eating an orange and protein bar. He also took sips of water. He reported feeling okay and felt comfortable leaving the pharmacy. Patient was called five hours later in the evening and he reported feeling fine since leaving.
17 hours after vaccination, tiredness, body aches, fever, chills lasted for approximately 36 hours. 5 days after vaccination, rash on both arms, chest, and legs. Lasted for approximately 12 hours.
Left ear - sudden sensorineural hearing loss (SSNHL). Treatment = high dose steroid (prednisone) for 2 weeks, then taper. Injection of high dose steroid into left ear (twice, one week apart). Outcome = almost 100% hearing restored.
Patient's arm was red and swollen. Patient stated her arm was warm to the touch. Patient had an office visit and received a steroid shot for the reaction.
2 inch diameter erythematous raised wheal to upper right arm, no s/s of infection.
Received 0.25ml of Bivalent booster instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) 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 ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml).    No concomitant information was reported. It was reported that none of the patients were pregnant. Vaccination date was reported from 01-SEP-2022 to 26-OCT-2022. No treatment information was provided. This case was reported for 15th patient out of 20 patients.
RAPID AND EXTRA HEARTBEATS - DIAGNOSED AS SVT (SUPRAVENTRICULAR TACHYCARDIA) ONGOING
She tested positive for COVID-19 and Influenza A on 12/21/22. She had a sore throat, cough, fever, and congestion. Her doctor looked at her throat and said that she had Strep throat like spots on her throat, so he prescribed an Azithromycin. She does not have a fever, but she is still dealing with a sore throat and cough.