chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The next day after vaccine was given the arm at vaccine at site of vaccine given was swollen, red and hot to the touch, Pt mom did not notify us till 3 days later she show us a picture of vaccine site and still was like 8 cm red but the swoelling was gone pt did not complain of aby symtoms . But its gone complete by now.
fevering; Bladder infection/Bacterial infection; has the shakes; doesn't feel like standing in line for the vaccine today.; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 13Apr2021 as dose 1, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced fevering, bladder infection/bacterial infection, has the shakes, doesn't feel like standing in line for the vaccine today, nausea, vomiting on 04May2021. The first dose of the Pfizer Covid vaccine on 13Apr2021 and is due to take the second dose today 04May2021. wants to know if delaying taking the vaccine one day because she has a bacterial infection and want to take one day to make this nausea go away. If I wait, will it affect the vaccine working on me. The caller has a bladder infection and is on antibiotics. wants to know if she can take the vaccine a day later the caller has been vomiting today and fevering and has the shakes from the bacterial infection and doesn't feel like standing in line for the vaccine today. Therapeutic measures were taken as a result of bladder infection/bacterial infection antibiotic treatment. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Developed acute onset chest pain, and found to have elevate troponin. His acute chest pain resolved almost immediately upon admission to the hospital, and his troponin started to downtrend over 48h.
PATIENT RECEIVED THE VACCINE AND 5 MINUTES LATER HE STARTED HAVING SEIZURE LIKE MOVEMENTS, SWEATING EXCESSIVELY AND DROPPED EVERYTHING IN HIS HAND. THE PARAMEDICS WERE CALLED AND ONCE THEY ARRIVED THEY COMPLETED COUPLE OF TESTS. THEY SAID THE PATIENT MAY HAVE BEEN DEHYDRATED. PATIENT STAYED AT THE PHARMACY FOR ABOUT 15-20 MORE MINUTES AND LEFT TO HOME.
Patient received / the liquid component / without / the powder portion; Patient received /  the liquid component / without / the powder portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 21-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA397A, expiry date 31st August 2022) for prophylaxis.   On 4th June 2021, the patient received Menveo (intramuscular). On 4th June 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received a dose of the liquid component of Menveo without being reconstituted with the powder portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reported batch number of AMXA397A was not found in sales data sheet, hence updated to AMVA397A. The reporter consented to follow up.
After some expected soreness at the injection site I experienced after 5 days extreme chills and severe night sweats. Slightly elevated temperature, nothing over 99. After several days of this, I began experiencing moderate headaches, insomnia and fatigue on a daily basis. I continue to experience these symptoms and am very worried.
after 1 week of getting the vaccine.  My left arm at the injection sight. Is red going down my arm and hot to touch
Information has been received from a health professional concerning a 5 year old patient who on 31JAN2000 was vaccinated with a dose of varicella virus vaccine live. On 24MAR2003 the patient developed break through chickenpox. It was unknown if medical attention was sought. No product quality complaint was noted. It was also noted that 12 other patients were vaccinated with a dose of varicella virus vaccine live and developed break through chickenpox. Additional information has been requested.
no adverse event occurred. patient received a booster dose of the moderna vaccine 1 month too early
PATIENT REPORTED: PAIN ENCOMPASSING ENTIRE BODY, SPLITTING HEADACHE, DIZZINESS/LIGHTHEADEDNESS, COUGH, BURNING EYES, AND SHORTNESS OF BREATH THAT HAVE IMPROVED OVER 3-4 DAYS.
Day 1 - Day of Dosing @ 5pm - Slight soreness in right arm Day 2 - Fever up to 100-101, cycling up and down for appx 36 hours, starting about 12 hours after vaccination. Body aches, sore glands in neck, sore kidneys, chills, - lasted about 20 hours starting about 12 hours after vaccination.  Day 3 - body aches, soreness, chills all gone upon waking up. Fever up to 100 still on and off until about dinner Day 5 - Delayed local injection site reaction on left arm about the size of a small mango. Felt hot and a little itchy.  Day 6 - Delayed local injection site reaction continued. No pain/discomfort to note Day 7 - Delayed local injection site reaction continued. No pain/discomfort to note. Redness/welt is improving.
21 year old male presented to ER with local reaction to smallpox vaccine, had smallpox shot a wk ago. When going to bed noted area raised and painful with red strip on upper arm with red streak to axilla. Given Toradol 60 mg IM in ER. Wound dressed, sent home, F/U in am.
ARM RED, AND BLISTER BUBBLE AT SIGHT OF INJECTION THAT HAS GROWN LARGER
Itchiness around the injection site; Soreness under her armpits; Redness around the injection site; Swelling around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness around the injection site), AXILLARY PAIN (Soreness under her armpits), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE SWELLING (Swelling around the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 31-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness around the injection site), AXILLARY PAIN (Soreness under her armpits), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE SWELLING (Swelling around the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness around the injection site), AXILLARY PAIN (Soreness under her armpits), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE SWELLING (Swelling around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the event included iced injection site and applied heat.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
While taking amoxicillin for the 2nd time in several months for strep throat, I developed severe stomach pains that happened almost daily and continued even after my antibiotic course ended. They have lasted for months and continued in conjunction with a new diagnosis of acid reflux. The stomach pains happened as my stomach digested a meal. They are finally getting better after 2 months on a generic version of prilosec. I can no longer eat eggs as they cause the stomach issues to recur.
had 3 lyophilized parts of the vaccine and no "diluents" / suspect /patients got the liquid adjuvant only; had 3 lyophilized parts of the vaccine and no "diluents" / suspect /patients got the liquid adjuvant only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The reporter was a pharmacy student. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The reporter stated that the patient might had been administered only the liquid adjuvant portion of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that they had lyophilized part of the vaccine and no diluent, so they suspect that patient got the liquid adjuvant only. The reporter consented to follow up by email as HCP had no details at time of reporting. This was 1 of 3 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR084958:same reporter US-GLAXOSMITHKLINE-US2021AMR084959:same reporter
Severe upper abdominal pain for 3hours pain subsided after that time but pain was managable for the next 12 hours. Puffyness at injection site.
TONGUE SWELLING, TINGLING SENSATION IN MOUTH, METALLIC TASTE IN MOUTH, ITCHING TO ROOF OF MOUTH AND THROAT TREATMENT WAS BENADRYL ONE 25MG TAB PO AT 11:25 AM AND EPINEPHRINE 1:1000 (1 MG/ML) 0.3CC SQ AT 11:30 AM.
No Adverse Event; 1st dose - 05Mar2021, 2nd dose - 19Mar2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 05Mar2021, 2nd dose - 19Mar2022) and NO ADVERSE EVENT (No Adverse Event) in a 64-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 016F21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 05Mar2021, 2nd dose - 19Mar2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 05Mar2021, 2nd dose - 19Mar2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.  Concomitant drugs were not reported. It was reported that patient wants to verify the expiration date of a Moderna COVID-19 vaccine lot number which was administered to them for second dose and was told as was working for that this had already expired. Treatment medications were not provided.
Approximately 6 1/2 months after receiving the ZOSTAVAX Shingles vaccine, diagnosed with bad case of Shingles - large, red painful rash radiating from middle of back, under (L) arm and breast. Treated with VALTREX, Lidocaine Gel, ATARAX; DARVOCET. Mod to mild pain after Shingles rash dried up. Still recovering.
This spontaneous report was received from a 75 year old female patient regarding herself. Concurrent conditions include allergy to KEFLEX and unspecified steroids. No medical history reported. On 08-OCT-2014 the patient was vaccinated with PNEUMOVAX 23, 0.5 ml through an unspecified route. Concomitant therapies included LIPITOR, nifedipine (manufacturer unknown), lisinopril (manufacturer unknown) and hydrochlorothiazide (manufacturer unknown), baby aspirin, ZOSTAVAX and influenza virus vaccine unspecified. On 08-OCT-2014 the patient experienced her whole upper arm got very red and hot and that she could barely raise her arm because of the pain (disability). On 09-OCT-2014 the patient experienced pain seemed to travel down her chest, under breast and behind her back, she had two red streaks coming out of the injection site and towards her elbow. The patient received treatment with BENADRYL and ibuprofen (manufacturer unknown). It was also reported that on approximately on an unknown date in September 2014 (also reports as a week and a half) prior to receiving her PNEUMOVAX 23 she received both ZOSTAVAX and influenza virus vaccine unspecified. The outcome of the events was reported as recovered on 15-OCT-2014. The causality for the events was unknown. It was reported that the patient did not sought medical attention. No product quality complaint reported. Additional information has been requested.
Patient developed fever, 100 degrees, 2 days after flu vaccine; rash on feet, buttocks, mouth; raised, individual, itchy. Feet fiery red. Went to ER 2/17/12. Given prednisolone with BENADRYL x 5d. As of 3/1/12 feet peeling.
Patient contracted COVID after being fully vaccinated Cough, Congestion, Fever, Headache, Fatigue, Body Aches
Site: Pain at Injection Site-Mild, Systemic: Tachycardia-Medium. Additional Details: Patient  received shot; feeling good but her son with her was monitoring her HR. He said it was elevated after the shot. EMS came to evaluate because patient was concerned about getting up. She has a history of atrial fibrillation.
Patient received his second Pfizer dose 14 days from the first Pfizer, he was supposed to have 21 days in between.
Nauseous; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed , UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nauseous".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After about 12 hours I started having muscle aches in both arms which then became full body ache like flu symptoms.  Fever chills during the night.  Still had 99.5 fever at 7 this morning and dull headache.  Took 2 Tylenol.  Still sore but getting better.
Sib Dx'd with VZ, pt seen for routine well care and had healing scabs from VZ. No Rx given. 2nd dose of VZ and MMR held by Dr order d/t recent illness of VZ. Pt to f/u for vaccination in 2 mo. Unsure if qualifies for "vaccine failure". Ordered by dr to report.
Felt fine after shot, major muscle aches when I went to bed, woke up unwell at 7:00 am.  Passed out in bathroom (syncope), hit face on floor (split chin).  Woke up disoriented.  Spouse tried to help me to bed, but passed out again in his arms (syncope).  Woke up to paramedics' questions.  Very disoriented.  Went to  ER by ambulance.  Blood work and CT Scan normal (except thinning bone in right ear).  Slept almost continuously, even through testing, couldn't really open eyes.  Arrived home about 1:00 pm, and slept until about 5:00 pm.  Slept through the night, but still very tired today (Monday).
1/19 had moderna covid vax and small lump developed after 7 days that has now doubled in size over the last 24 hours - no red streak. no fevers, chills, sweats. measured 1.5in x 2in diameter
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jun2021 as dose 1, single (Lot number: EWO180), in left arm, on 07Jul2021 as dose 2, single (Lot number: EYO0584) and on 14Jan2022 as dose 3 (booster), single (Lot number: FJ6369) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history included: "Sjogren's syndrome" (unspecified if ongoing); "ANA-anti nuclear antibodies" (unspecified if ongoing), notes: ANA-anti nuclear antibodies; "Known Allergies: Penicillin" (unspecified if ongoing), notes: Known Allergies: Penicillin. The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Known Allergies: Aspirin", notes: Known Allergies: Aspirin; NSAIDS, reaction(s): "Known Allergies: NSAIDS", notes: Known Allergies: NSAIDS; Ampicillin, reaction(s): "Known Allergies: Ampicillin", notes: Known Allergies: Ampicillin; Sublimaze (fentanyl) anesthesia, reaction(s): "Known Allergies: Sublimaze (Fentanyl) anesthesia", notes: Known Allergies: Sublimaze (Fentanyl) anesthesia. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: anti viral details: product COVID 19 Treatment, brand Paxlovid by Pfizer, treatment start date 02Sep2022, lot number GE1600, indication Treatment of COVID-19.
Developed Cellulitius. Severe swelling that traveled. By March 6th - patient needed to go back to the Dr. for antibiotics to offset the Cellulitis that was traveling.  Required 7-10 days antibiotics and multiple visits to Dr.    Assumed at the time it was possible " bad shot - however, we gave him ANOTHER dose of Tdap on 8/4/2020 and had the exact same reaction.  Clearly - this child develops Cellulitis immediately with these immunizations.
Large bruising on shoulder from posterior to anterior (purple, yellow, red). Scab at injection site. Sore b/c bruised. Looks like a low injection site. Bleeding at time of injection. Used own pain meds and ice.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No information provided regarding medical history, concurrent conditions and drug reactions/allergies reported. On an unknown date of MAY-2014, reported as early May, the patient was vaccinated with ZOSTAVAX (dose, route, lot# not provided). No concomitant medications reported. On an unknown date of MAY-2014 the patient received a dose of ZOSTAVAX at a local pharmacy clinic and patient reported that ZOSTAVAX was administered in patient's stomach area. No adverse effects reported. PQC not involved. Additional information has been requested.
Hives/rash all over arms and legs 2 weeks after 1st vaccine. Hives still ongoing 4 days later. Started noticing them at 6:00 pm on 4/23. Taking Benadryl initially and then Zyrtec to minimize itching.
Lower back pain as of yesterday and today; I felt hot weak; Heavy pressure in the center of my chest with a tingling feeling; Heavy pressure in the center of my chest with a tingling feeling; Headache and when I bend down or sleep flat, or after eating a meal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jul2021 14:00 (Lot number: FA7485) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimotos" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: ASTHENIA (non-serious) with onset 31Jul2021, outcome "recovering", described as "I felt hot weak"; CHEST DISCOMFORT (non-serious), PARAESTHESIA (non-serious) all with onset 31Jul2021, outcome "recovering" and all described as "Heavy pressure in the center of my chest with a tingling feeling"; HEADACHE (non-serious) with onset 31Jul2021, outcome "recovering", described as "Headache and when I bend down or sleep flat, or after eating a meal"; BACK PAIN (non-serious) with onset 04Aug2021, outcome "recovering", described as "Lower back pain as of yesterday and today". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of asthenia, chest discomfort, paraesthesia, headache, back pain.  Additional information: Known allergies: None. Facility where the most recent COVID-19 vaccine was administered: facility. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: Levothyroxine 112 mcg. Reported Event: About 5-7 minutes after receiving the vaccine patient felt hot weak and heavy pressure in the center of her chest with a tingling feeling. As soon as the nurse allowed in the back room where it was very cool from the AC being on then her symptoms went away. It's now been 5 days since she received her vaccine and she had a headache and when she bend down or sleep flat, or after eating a meal, she could feel her headache more. Lower back pain as of yesterday and today. Adverse event start date: 30Jul2021. Adverse event start time: 02:15 PM. AE resulted in: [None of the above]. If treatment AE: No. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Yes, covid test post vaccination covid test type post vaccination=Nasal Swab, covid test date= 30Jul2021, covid test result= negative.  Follow-up attempts are completed. No further information is expected.
Patient reported that he was feeling light-headed, per Nurse, patient looked a little pale and was bradycardic. Patient refused to go to the ED and stated that he would like to avoid it as much as possible. Patient was placed on floor, legs up on chair, given 2-3 water bottles to drink, one can of juice and cookies. Patient did not feel significantly better after 35 min of observation and finally agreed to go to the ED for follow-up and care.
This spontaneous report was received from a healthcare worker refers to multiple patients of unknown age and gender. The patients concurrent conditions, pertinent medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (digital data logger) (lot # K020182, expiration date 25-JUN-2016). The vaccine was exposed to the temperature: 48.9F with the time frame of 1 hour 10 minutes. There was no previous exposure. This is one of the several reports received from the same reporter. Additional information has been requested.
RECEIVED FLU VACCINE THROUGH EMPLOYEE HEALTH FLU VACCINE CLINIC AT 10:10 AM, RETURNED TO CLASSROOM BEHIND CLINIC FOR CLASS AND STARTED FEELING LIPS TINGLE AND SKIN FLUSHED, HOT, SHAKING, HR INCREASED, DIFFICULTY SWALLOWING.
Vaccines above given at 1530. Dad was waiting around for the discharge summary. Dad had taken Patient to the bathroom. At 1600 Dad informed our MA that Patient was itching and red. The M.A. then informed Dr. and myself about Patient symptoms. Me and Dr. walked to the room, where Patient was sitting with his Dad. Patient was very irritable, agitated, copios oral secretions with vomiting and very diaphoretic. At 1615, Dr. assessed and ordered EPI PEN 0.15MG and 25MG BENADRYL. EPI and BENADRYL given as ordered by patient did not tolerate the BENADRYL. He spit out the BENADRYL. Breath sounds were cleared. Pt didn't tolerate placing the CR monitor or Pulse OX on him. 1630, BS remained  clear but remained agitated diaphoretic and continue to present with hive. At this time Dr. informed me to call 911 while she called Hospital to give report. At 1645, 911 arrived and was taken to Hospital.
Tinnitus started about a week and a half after the first dose of the vaccine and has not resolved at this time.