chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the improperly stored dose of ZOSTAVAX (lot # M019646, expiration date 18-JUL-2017, subcutaneously; dose was not reported). No adverse effects were reported. The vaccine was stored in 10F for 48 hours and on the another date, in 10F for 24 hours. The call was made because of the data logger. This is one of several reports received from the same source. Additional information has been requested.
Tinnitus, ringing in the ears that has not abated since the time of the vaccine.
pt vaxed 4AM 12SEP95 & 730AM 13SEP95 mom noticed pt had a t101.4 ear & hives over trunk, arms & legs;called MD who prescribed APAP;hives returned & were larger & more widespread w/t102;taken to ER & treated as a vax rxn given Prelone & DPH;
covid expired 3/17/2022 the day before and gave a dose of this. on 3/18/2022
This spontaneous report as received from an healthcare worker refers to unspecified patients of unknown ages. Since an unknown date in July 2014, the patients were vaccinated with improperly stored ROTATEQ (lot#, strength, dosage, frequency and route unknown). No adverse effects were reported on the reporting time. This is one of several reports received from the same reporter. Additional information has been requested.
Hallucination; Back pain; Burning sensation; Confusional state; Diplopia; Disorientation; Hypoaesthesia; Vomiting; This case was received via  FDA VAERS (Reference number:) on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of HALLUCINATION (Hallucination) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced HALLUCINATION (Hallucination) (seriousness criterion medically significant), BACK PAIN (Back pain), BURNING SENSATION (Burning sensation), CONFUSIONAL STATE (Confusional state), DIPLOPIA (Diplopia), DISORIENTATION (Disorientation), HYPOAESTHESIA (Hypoaesthesia) and VOMITING (Vomiting). At the time of the report, HALLUCINATION (Hallucination), BACK PAIN (Back pain), BURNING SENSATION (Burning sensation), CONFUSIONAL STATE (Confusional state), DIPLOPIA (Diplopia), DISORIENTATION (Disorientation), HYPOAESTHESIA (Hypoaesthesia) and VOMITING (Vomiting) had not resolved.        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.   No concomitant medication was reported.  Treatment drug information was not given.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Rash on chest, neck, upper back appeared about an hour and a half after vaccine administration.  Took 50 mg Benadryl  at 7:15pm (about 2 hours after vaccine).  Rash diminished slightly after 1 hour, nearly mostly gone at wake up at 7am the following morning (8/28/21).
Prior to vaccination patient appeared anxious and resulted in nose bleed. During observation period time vitals assessed. Pt reports needle anxiety; spoke clearly without difficulty; A&O x3. Vitals: BP: 90/60; HR 70; O2 Sat: 98% in room air; RR: 20. LPN educated in slow deep breath techniques, provided water, and educated to keep car cool. Vitals re-checked at 1429: BP: 112/80; HR: 70; O2 Sat: 98% on room air; RR:20; pt reports feeling "dizzy" and stated she did not eat prior to vaccine. LPN provided OJ and crackers; continued to monitor for 25 full minutes. Pt reports "feeling better" after interventions; vitals within range; spoke clearly without difficulty; pt and family educated on high alert symptoms as well as continuing deep breathing and avoiding the sun. Pt left at 1435.
5/1/08 given vaccine; 5/3/08 seen in office with ? cellulitis extending from above in elbow site to below elbow, warm, indurated, erythematous; given treatment; rechecked on 5/6/08 improvement.
Headache, very tired and achy; shortly after I notice some hair loss I was getting much more hair in my hands when I would shampoo. The hair loss has slowed down a little bit. I have started using different shampoos to mitigate. I had discussed with primary care regarding the hair loss as well.
5 min after the shot, throat and chest began to feel slightly tight; nurse monitored for 45 min; no other symptom changes or treatments given;  65 hours later woke up with a swollen face and generalized rash on throat - this is current state at time of submission so final outcome unknown at this time
Patient reported pain in her (L) arm with limited range of motion first reported within 24 hours of vaccine. Was evaluated by primary care provider. Pain & limited range of motion persisting.
she has moderate covid; she has moderate covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 81-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she has moderate covid". Clinical course: Reporter mother who was 81 received the booster bivalent vaccine about a month ago, and she had moderate covid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
6 cm area of erythema surrounding vaccine site appearing 2 days after administration in left deltoid.
Localized redness and pain at injection site - No itching. Physician prescribed Hydroxyzine Hcl for reaction.
Large, red rash covering neck, chest, and abdomen. Painful, swollen lymph node in right armpit. Pain at the injection site. No treatment other than rest.
Fainted, chills, fever, aches, nauseated, restless, fatigue, headache
Received vaccination at 8:30, was fine at dinner went to bed at 10:00 pm. Severe chills headache2:00 am chill stopped still cold and headache. Felt like I had been in a car wreck. Next day cold, headache diarrhea. Next day tired but better.  I?m concerned, what will happen with the next vaccination.
In the middle of March, I began to notice a sore, warm lump in my right breast. The skin in the area became red and flaky, so I arranged to see my gynecologist, Dr. I saw Dr. on 4/1/2021. She did a breast exam and ordered a mammogram with a potential ultrasound. On 4/15/2021, I underwent a mammogram at Hospital. After the mammogram, it was determined that an ultrasound was also needed. After the ultrasound and mammogram, the radiologist suspected that I likely had a cyst, but to be sure, he asked me to come back in a month for a follow-up to ensure that the cyst had diminished. The cyst began to get smaller and less painful. When I came back for the follow-up, the radiologist decided that it was indeed a cyst and that no further follow-up was needed.
Baby had been in the office for a new patient well baby check and needed vaccine. Baby had been fine  for the 48 hrs prior to event. Mom heard baby crying about 11: 30 on 4/8/2020. She went in to get him . She picked him up and heard a gasp. He then went limp and turned blue. She started CPR and grandmother called 911. Paramedics found the baby in asystole. They intubated the baby but never got a heart beat . The medical examiner was called. She sent the baby for autopsy.   She started that on her exam she could find nothing obviously wrong with the baby.
Patient developed 1/2 dollar sized swelling to left deltoid. Hard on palpation. (no redness). Influenza given in left arm. Assessed by doctor, medical resident.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: ?
She did not present her period; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she did not present her period. The outcome for event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
pain I felt when they applied it on my arm; feeling ill; reddened; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine (unknown arm). On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: pain I felt when they applied it on my arm), feeling unwell (Verbatim: feeling ill) and erythema of extremities (Verbatim: reddened). The outcome of the pain in arm, feeling unwell and erythema of extremities were not reported.   It was unknown if the reporter considered the pain in arm, feeling unwell and erythema of extremities to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm, feeling unwell and erythema of extremities to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-JUN-2023. This case was reported by a patient via interactive digital media. The reporter itself the patient. The patient was completely fine, but as soon as they put the vaccine, apart from the pain patient felt when they applied it on his/her arm, and it reddened.  The patient started feeling ill, patient called the doctor and they requested patient that he/she had to visit for the other vaccine in two weeks because had to complete this one because patient was injected the herpes zoster and if patient had known, would not had taken the injection because patient had taken all the vaccines. Patient had taken all of them, but they do not tell this. The patient had a friend who was a doctor and he told this to them. The patient realized then when they had already given it to him/her.  They give patient the herpes zoster and then patient had to take it once again to combat. The follow-up could not be possible as no contact details were available.
Injection site was red swollen and bumpy. Painful to the touch and itchy. As the week went on, the redness looked more like a rash and started to spread. After 4 days, it had spread to her neck and she was developing small spots up and down her arms. Finally by day 5 the rash was bright red and had spread all over her body. She is itchy and her skin is swollen, especially around her arms and face. Took her to urgent care on Sunday 11/01/15 and then followed up at her doctor on Monday 11/02/15. Doctor agreed that it was a sever reaction to the varicella vaccine.
Less than 24 hours after vaccinations were administered patient had redness around both eyes with facial swelling.
Abdominal pain and lower back pain started on May 15, 2021.  No fever, nausea or vomiting.  Labs on 5/22/21 showed elevated white blood cells and neurophils.  CT Scan confirmed acute appendicitis  on 5/22/21.  Appendix removed on 5/22/21.
Reaction 10 days after pt injection. On 9/12/12 pt vaccinated with FLUZONE; 1st pt has stomach cramps and nauseous - lasting about 8-10 hours. Doesn't impact pt. appetite. Pt reports increase in saliva and burping, no passing wind. Pt. believes flu shot to have adversely affected him in past yrs. Pt. reports multiple episodes of stomach cramping and muscle soreness.
This spontaneous report as received from a doctor of pharmacist refers to a newborn patient. The patient was inadvertently vaccinated IM with a dose of PNEUMOVAX23 (0.5 ml, lot# not reported) instead of RECOMBIVAX HB Pediatric dose on 08-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information is not expected.
Pt recvd Engerix-B & later the same day exp a drop in pulse, drop in BP & fever;
ZOSTAVAX SQ (R) arm 1-23-13 120pm shortly after administering she developed itching, redness and slight swelling at injection site. 10 min later- swelling went down pt was better when she left office.
Child passed out in chair, hit the floor and continued to lose conciousness for 15 seconds.
Day after vaccination member states left arm became very painful, warm to touch and hard to move. member stated other normal reactions ( headache, stomach ache that went away). members left arm has a 50+ mm rash that developed anterior of the vaccination site. The day after the vaccination that is still hurting and warm on day 3.
C/O HA appox 10 mins after shot then C/O of feeling hot appox 20-30. Checked vs all where normal, had him drink water and sit down for appox 20 minutes.
Within 8 hours, I developed a headache and persistent nausea. The headache is gone, but the nausea remains (Friday, 10.29, 4:15pm). Sore throat, runny nose. None of this is concerning or surprising. Similar reactions to first and second doses as well.   Starting about 24 hours after booster, injection site has very large, hard, hot, red circle that is spreading (started about the size of a quarter, is now about the size of my palm), and have had intermittent hives, particularly when even slightly overheated ? this is not typical for me. About 48 hours after booster, have an elevated temperature and hot flashes, not over 100, but 2* higher than my average using same measurement location & thermometer (usually 97.2ish, but today had several consistent readings of 99.3).
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 8th May 2018, the patient received the 1st dose of SHINGRIX. On 8th May 2018, 11 hrs after receiving SHINGRIX, the patient experienced pain in arm, chills and gastric disorder. On an unknown date, the outcome of the pain in arm, chills and gastric disorder were unknown. It was unknown if the reporter considered the pain in arm, chills and gastric disorder to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX at 09:31 hours. The patient reported that about 11 hours later, at 20:31 hours the patient experienced arm soreness and sick to stomach.
Diarrhea, vomiting, nausea, abdominal pain that goes to back and to legs, deep vein thrombosis (DVT)
One day after Flu hot patient developed temperature 100.0, vomiting and diarrhea. All symptoms now resolved except diarrhea.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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)) (batch no. 023C22A) for COVID-19 prophylaxis.     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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    This case contains information of the 14th patient out of 20 patients.  No concomitant and treatment medications were reported.
I can feel my heart beating fast and hard.  I sometimes get chest pain and back pain.  I am so fatigue.  I went to my cardiologist about this.  My blood pressure has been very high.  They did Sonogram and EKG. I will find out when I go back to my doctor, I will find out the results. I also been experiencing SOB as well.
Cellulitis (2 Weeks), Swelling/Redness/Pain/Tenderness/Lumps Under Skin at Injection Site (7 Months), Fever (10 Days), Vomiting (1 Morning).  Treated with Keflex and Bactrim (7 Days).
This spontaneous report as received from a nurse practitioner refers to a 8 year and three quarters old male patient. The patient's pertinent medical history was not reported. On an unknown date the patient was vaccinated with 1st dose of GARDASIL (dose, frequency and route were not reported). The patient received GARDASIL before his 9th birth day. No adverse effects reported. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
FEVER-101.7 Big red mark around injection area, that got bigger as time passed, from armpit to elbow, also lot of pain. Went to emergency center, 10/3/10 12:16 PM, was sent home after I had
Subject called pharmacy to report a significant reaction occurring at the injection site ( rash, red, itchy) as well as significant swelling/hardness in the biceps area. Symptoms resolved/lessened by the next day (11/20) after benadryl and cold compress.
Sore throat; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced sore throat. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore throat was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This medical assistant reported similar events for three patients. This is the third of three reports. This is a spontaneous report from a contactable medical assistant. A 4-year-old male patient received a dose of PREVNAR13 intramuscularly on the leg on 11APR2011. Relevant medical history was none. Relevant concomitant vaccine included measles, mumps, and rubella vaccine, varicella virus vaccine. Relevant past product history included PREVNAR at the age of 2 months. Vaccine taken within the last four weeks were none. On 12APR2011, the patient developed hardening of skin, hives, little bumps and warmth at the site of injection. Relevant lab data was unknown. At the time of the report the outcome of the events was unknown. Follow-up (27MAY2011): Follow-up attempts completed. No further information expected.
Had been previously admitted from 8/27-8/31 with +COVID and acute hypoxemia and discharged with good oxygenation on dexamethasone and levoquin for UTI.  Admitted again on 9/2 due to worsening dyspnea from covid pneumonia. Treated with zyvox and zosyn on high flow oxygen. Continued to decline and admitted to ICU on 9/3 and intubated. Given remdesevir and continues steroids. Found bilateral IJ and subclavian vein thrombosis. Transitioned from eliquis to lovenox. Unable to be weaned from the ventilator. Family involved in care and transitioned patient to comfort care and patient was extubated and passed on 9/11/21.
kidney disease; heart condition; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 86 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 86 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Jan2021, when the patient was 86 years old, for COVID-19 immunization. The following information was reported: RENAL DISORDER (non-serious), outcome "unknown", described as "kidney disease"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart condition". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Significant pain at injection site, worsening overnight.  24+ hours later I am still having difficulty raising my L arm to shoulder level.  Significant point tenderness as well.  Pain about a 6/10.
Patient received vaccine at the location and was seated in the waiting area with other family members.  Approximately 5 minutes after receiving the vaccination, she became unconscious and her family alerted me to this reaction.  We immediately called 911 and I assisted the patient to the floor with a soft surface under the head.  Patient became responsive once in the prone position and began to speak with us.  Vitals were monitored and EMT reached the scene and took over within 5 minutes of our call.
9 YO was given Boostrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9ZK5T, expiry date 7th October 2024) for prophylaxis.   On 20th December 2022, the patient received Boostrix. On 20th December 2022, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 20-Dec-2022 Reporter's comment: The reporter confirmed administered at alternate facility (at a school). The reporter called to inquired about any guidance or recommendation. The expert mentioned additional details that given intentionally as a catch up dose but health care professional did not realize it was not to be given to a patient under 10 years of age. The reporter did not consent to follow-up. Additional supportive information: The patient was inadvertently administered Boostrix on the day of reporting about 4 hours ago at inappropriate age, which led to inappropriate age at vaccine administration.