chrisvoncsefalvay/vaers-outcomes huggingface dataset:
An initial report was received from another manf on 06Jul05. Manf had received an initial and follow up report from a licensed practical nurse regarding a 77 year old female who on 15Oct04 at 9:50AM was vaccinated IM in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P). Concomitant therapy included a fourth dose of Fluzone (lot U1380AA) administered in the left deltoid. It was reported that the pt developed a red swollen arm at the injection site after receiving pneumococcal 23v. It was also reported that the pt was seen in the clinic and diagnosed with cellulitis. The pt was treated with an antibiotic. The reporter indicated that the cellulitis was considered to be an important medical event (OMIC). The nurse reported that two other female pt's had similar experiences with the pneumococcal 23v in the past two weeks. There was no product quality complaint involved. Follow up information from the nurse indicated that the pt developed pain, erythema and swelling in the right upper arm about two to three hours after the injection. The pt also had chills and nausea but no fever. The nurse suspected an infection or a possible allergic reaction; however, the pt has no history of drug allergies. It was reported that the pt recovered, date not specified.
Pt states states they had itching after and are on blood thinners, anxious before shot. Vaccinated patient with J&J. In observation area they began to feel unwell, we supported them and lowered them to ground with pillow supporting head and knees up for comfort. They regained consciousness. Medical personnel applied a cold pack, washcloth, and cooling fan. O2 sat 99 and pulse approx 100 by pulse ox. Pt family brought to their side to comfort them. Pt began feeling better. Pt sat upright. Color improving. Pt now sitting and talking. O2 100 and pulse 86 by pulse ox. Pt feeling much better now seated back in chair within observation area accompanied by family at 1240. Seemed to recover fully, patient accompanied by family when leaving.
Suicidal ideation 24 hours after shot lasting for 3-4 days.
Around 530pm I noticed red, blotchy, some hive like bumps on my neck and face/chin. By around 7pm it was gone. Very slight itchyness. I do occasionally get similar reactions from food/lotions/pet hair/skin contact-most typically in the neck/face area. I did eat an ice cream bar with peanuts listed-which sometimes can cause neck hives for me-although these bars haven?t done this before.
PT REQUIRED TO TEST PRIOR TO RETURNING TO WORK DUE TO CONTACT TRACING
Changes to menstrual cycle.   I had a normally scheduled period about a week after the shot on 10/10.  I?ve had three more since then, with the most recent starting 11/28.  My cycle is normally pretty regular and about 30 days.  I had period changes last time I got the booster, but they were less dramatic.  This time my fever was higher with the booster (102.3 vs. 101.9 last year) but for a shorter duration (1 day vs. 3).
Patient reports after she received her first dose on 2/18/21 she experienced diarrhea, nausea, chills and body aches.
Shingles Outbreak; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles Outbreak) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HERPES ZOSTER (Shingles Outbreak). The patient was treated with VALACICLOVIR at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles Outbreak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Flu: Initial information was received on 02-Nov-2021 regarding an unsolicited valid social media non-serious case received from a consumer.  This case involves an adult patient (unknown age and unknown gender) who experienced flu (influenza) while receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I get my flu shot every year! And twice i had the flu real bad, i was told its a different type of flu".  It is unknown if the patient experienced any additional symptoms/events.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Received the vaccine on Wednesday 4/21/2021, had a colonoscopy on Thursday, and woke up Saturday morning, 4/24/2021 with achy back and wrists were reddened and swollen. Noticed both lower legs had areas of redness that worsened over the next several days. Took pictures and appeared to be large petechiae. Went to see her physician on 4/29/2021 and was given steroid dose pack and an antibiotic. The next day she woke up feeling better and her legs improved. She states you can still tell her skin looks patchy but all redness has resolved. Legs did not itch and were not painful. Her ankle joints did become sore along with her wrists making walking  difficult. No other symptoms. Presented to get her second dose of Moderna when she informed us of her reaction Second dose was not given based on this information.
This spontaneous report as received from a Nurse refers to a patient of unknown demography. On 28-JUL-2016, the patient was vaccinated with RECOMBIVAX HB (strength: 5/0.5 microgram/ml) (lot was unknown), intramuscular and on the same day, the patient was also vaccinated with PEDIARIX at an unknown injection site (Overdose and inappropriate schedule of drug administration). No adverse effects reported. No further information provided. No PQC involved. Additional information had been requested.
After receiving 3 doses of vaccine 10/12/2021- ultrasound on neck routine followup for a nodule on right side of thyroid. Enlarged lymph nodes noted on left side of neck. FNA showed small percentage of suspicious cells. 10/29/2021 - routine mammogram showed enlarged lymph nodes   Prior to receiving vaccines 9/17/2020-CT scan of neck with contrast-right nodule on thyroid 1st found, but not any enlarged lymph nodes on left side of neck were noted. 2/22/2021- Low dose lung scan-no enlarged lymph nodes in throracic area
Mom states child taken to ER later in day after getting 4 month old immunizations (8/18/03). Child had a fever of 106 and was hospitalized for 3 days. Child has been hospitalized 3 times since 8/03 with high fever (>105) per mom. Child has been diagnosed with asthma, reflux and uses nebulizer at home. Vomiting and dehydration.
Excruciating head ache from neck to the front of the head, pulsating throbbing pain, tiredness
her very ill after the 2nd shot; Patient had COVID-19 and received COVID-19 vaccine; Patient had COVID-19 and received COVID-19 vaccine; This is a spontaneous report from a contactable consumer. An 80-year-old female patient received the second dose of (at the age of 80-year-old) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#: not known), via an unspecified route of administration on unspecified date at SINGLE DOSE for COVID-19 immunization.  Medical history included ongoing COVID-19.  Concomitant medication included apixaban (APIXABAN) from unknown dates and indications. The patient previously received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on an unknown date and the patient experienced COVID-19. It was stated that the patient had COVID-19 and received COVID-19 vaccine which made her very ill on an unknown date after the 2nd shot. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
hematuria Narrative: Employee stated that she had hematuria with clots the morning after her vaccination, It was recommended that she see her private physician
Erythema, swelling and heat at injection site, visit to PCP with prescription of antibiotics with improvement
back pain; congestion; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4283582-00.  A 49 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Mar2021 (Batch/Lot number: unknown) at the age of 49 years as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous, administration date Feb2022 (Batch/Lot number: unknown) as unk unk, daily. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "recovered" (2022) and all described as "COVID-19"; BACK PAIN (non-serious), outcome "not recovered", described as "back pain"; UNEVALUABLE EVENT (non-serious), outcome "not recovered", described as "congestion". The action taken for adalimumab was dosage permanently withdrawn.  Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's assessment of the causal relationship of reported adverse events VACCINATION FAILURE, COVID-19, BACK PAIN and UNEVALUABLE EVENT with the bnt162b2 (BNT162B2) was provided as possible.  Reporters assessment for causal relationship of reported adverse events VACCINATION FAILURE, COVID-19, BACK PAIN and UNEVALUABLE EVENT with adalimumab (HUMIRA) was not reported.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is  reasonable possibility of causal association between the events drug ineffective, COVID-19, back pain, unevaluable event and the suspect drug BNT162B2
pain in upper right lobe, difficulty getting deep breath, dizziness, lightheaded, unable to perform typical strenuous activities as before, pain and difficulty breathing wakes me up in the middle of the night,
This spontaneous report was received from a nurse referring to unknown number of patients of unknown age and gender. No information about patients' medical history, concurrent conditions and concomitant medications was reported. On an unknown date on or after 05-APR-2016, the patients were vaccinated with improperly stored doses of PEDVAXHIB which had lot # L036685, expiry date: 12-AUG-2016 (dose and route not reported). The vaccine was exposed to temperature of 34 degree Fahrenheit for 3 hours. No previous temperature excursion was reported. The temperature excursions were detected by a data logger. Additionally, no adverse effects were reported and no product quality complaint (PQC) was involved. Additional information ahs been requested.
Came to the pharmacy with pain and redness in the area. Call Dr. She prescribed Cefprozil 500 bid x 8 d.
Redness, heat, swelling left thigh. Now 4mm firm, nontender mass left thigh.
Slight redness and swelling at injection site, pt saw nurse practioner and circled redness area pt came to pharmacy 4 days later swelling and redness gone still complained of pain.  return to pharmacy 11-22-2016 and said still pain at injection site however  not shoulder or elbow.
pt awoke w/welt on side of abdo; 430PM 12AUG DPH; 7PM seen in urgent care clinic; 13AUG93 8AM seen by MD reports no local, no fever, joint pain, mild h/a w/malaise; welt & swelling on lips; rash;
Patient reports onset of symptoms about an hour after receipt of the flu vaccine. States that she developed chest pain/pressure, weakness in left arm with a feeling of heaviness, and severe headache. She states that within 30 minutes from then, she also developed weakness/numbness in her left leg. She was seen in the ER shortly after symptoms began and admitted to the hospital until 10/12/20. She reports treatment included: EKG, medications, labs stress test, CT/MRI, walker, and referred to PT/Neurology. Outcome: Still experiencing some weakness to the left leg, no longer needs walker but using cane. Reports being "okay with walking, but lifting it is the issue."
fatigue   Narrative: Patient reported that 3 days after receiving the first dose of vaccine  he developed nausea and vomiting as well as fatigue. Patient reported the N/V  lasted only a day or two and the fatigue lasted approximately a week. symptoms  have resolved since then.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-MAR-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL (strength: 0.5 ml) lot # L020162 and expiration date: 23-JUL-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 120 hours, with the lowest recorded temperature of 1 degrees Fahrenheit (1 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a public health nurse concerning a pt who in August 00 was vaccinated with a dose of varicella virus vaccine live (Lot # 632727/0089K).  Subsequently, the pt developed chickenpox breakthrough. It was noted that this case was part of 4 cases of chickenpox breakthrough one of which was "mild" and the other three were"regular chickenpox". Unspecified medical attention was sought. Subsequently, all cases resolved. There was no product quality complaint involved. The reporter also mentioned three other pt's who developed chickenpox breakthrough and experienced similar reactions (WAES # 0403USA00650, 0403USA01867, 0403USA01869).  Additional information has been requested.
HSV1 severe outbreak; Arm soreness; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported), via an unspecified route, administered in left arm on an unspecified date (at the age of 25 years and she was not pregnant at the time of vaccination) as dose 1, single for covid-19 immunization. Facility type vaccine was other. The patient's medical history included PCOS, hyperthyroidism, TMD, HSV1. There was no other vaccine in four weeks. There were other medications in two weeks included methimazole 10 mg, escitalopram oxalate (LEXAPRO) 10 mg. There were no covid prior vaccination. There were no known allergies. The patient experienced arm soreness, fatigue, hsv1 severe outbreak on 16Apr2021. She was not tested covid post vaccination. She did not receive treatment for adverse events. The outcome of events was recovering.  No follow-up attempts were possible. information about lot/batch number could not be obtained. No further information was expected.
This case was reported by a physician via sales rep and described the occurrence of dizziness in a male patient who received SHINGRIX. Previously administered products included SHINGRIX (received 1st dose on an unspecified date). On 23rd May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced dizziness and chills. On an unknown date, the outcome of the dizziness and chills were unknown. The reporter considered the dizziness and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician noted that the patient reported on the reporting date that he experienced dizziness, light headedness and chills. The reporter stated that no additional details were available.
This is a spontaneous report from a contactable physician who reported for his son. A male patient of unspecified age received TRUMENBA on unspecified date, at single dose. Medical history and concomitant medications were not provided. The patient experienced redness and pain at the injection site and flushing feelings on an unknown date after vaccination. Events outcome was unknown.
A few days after my vaccine i was sitting in a chair and touched my calf and noticed that it was numb. It wasnt pins and needles as if it had fallen asleep. It just had significantly decreased sensitivity. I stood up and walked around to try to fix this but the symptoms persisted for at least 36 hours before subsiding to a much lesser but still present degree of numbness. I went to my doctor and they told me that it was not an emergency aince there was no pain and it caused no weakness. This is localized to the skin on my outer left calf. He said this can be caused by crossing your legs too much but i dont ever do that. 3 weeks later and i still have muted sensations in my left calf. It mostly goes unnoticed until i go to scrub my leg in the shower or something and notice that the scrubber feels significantly different on each leg. The left side feels like "static".
Ha, passing out, R arm soreness, hot & cold, chills, sleepy, disorientated at work when driving here, SOB, troubles breathing
ear ache; scratchy throat on the right side; Neck Pain; pain; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (ear ache), OROPHARYNGEAL PAIN (scratchy throat on the right side), NECK PAIN (Neck Pain) and EYE PAIN (pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR PAIN (ear ache), OROPHARYNGEAL PAIN (scratchy throat on the right side), NECK PAIN (Neck Pain) and EYE PAIN (pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, EAR PAIN (ear ache), OROPHARYNGEAL PAIN (scratchy throat on the right side), NECK PAIN (Neck Pain) and EYE PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Consistent fever 99.5 F and chills starting at midnight on the same day of the injection, she has been taking Tylenol around the clock.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender who on an unknown date, within a one month period the patient was vaccinated with ZOSTAVAX (dose, route, frequency and indication not provided) dose 1, on an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, frequency and indication not provided) dose 2, on an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, frequency and indication not provided) dose 3. Nurse reporting that someone she knows has received 3 doses of ZOSTAVAX within a one month period. This person is not a patient where the nurse is employed. The person received the doses from 3 different pharmacies. No symptoms reported. No other details. The outcome of received 3 doses of ZOSTAVAX within a one month period was unknown. The reporter considered received 3 doses of ZOSTAVAX within a one month period to be not related to ZOSTAVAX. Additional information has been requested.
Fatigue, achy, tired, soreness in right arm, tingle/ slight numbness through all legs and arms that comes and goes, fever, chills
Breakthrough case admission after 3 vaccines Pfizer 3/29/21 Lot# ER8734;  Pfizer 4/19/21 Lot# Ew0162;  Pfizer 1/2/22 Lot# FJ8757
REDNESS AND WARM TO TOUCH ON INJECTION ARM BELOW INJECTION SITE. NO PAIN OR ITCHING.
PT WAS ADMINISTERED FIRST DOSE OF SHINGRIX ON 1/4/2021. FOLLOWING MORNING REPORTS REACTION (REDNESS AND SWELLING) BETWEEN INJECTION SITE AND ELBOW. ONE WEEK FOLLING INJECTION, PT REPORTS SEVERE SENSITIVITY AND PAIN ON FOREARM OF ARM THAT INJECTION WAS ADMINISTERED. PT WAS TOLD BY ANOTHER HEALTHCARE PROFESSIONAL THAT SHE HAD DEVELOPED A MINOR CASE OF SHINGLES. SYMPTOMS RESOLVED WITHOUT TREATMENT AFTER 2 DAYS.
disoriented; hit her head and cut herself; hit her head and cut herself; Passed out at night; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 23Dec2020 at single dose at left arm for COVID-19 immunization. Medical history included Atrial fibrillation/heart problems diagnosed prior to the vaccine, got the COVID virus on 18Nov2020, disoriented in Nov2020. Concomitant medications included her heart medication every day and vitamins, nothing out of the normal. Caller stated she had heart problems. The heart problems were diagnosed prior to the vaccine. Caller also stated that she got the COVID virus this year before the vaccine as well and she was off, of work for like a month. On 23Dec2020 she got the vaccine. Then on Thursday 24Dec2020 and Friday 25Dec2020 she had a reaction. She had passed out in the night, hit her head and cut herself, she was then disoriented for 1 full day. Caller stated that the last time she was disoriented like this was when she had the COVID Virus, because she had heart problems. Caller stated that she was fine now. Caller stated that she had been off, of work so much. The heart problem she had was Atrial Fibrillation. Caller clarified that she had the COVID virus this year in Nov2020, it was before thanksgiving, on 18Nov2020 she had the virus, then on 19Nov2020 she got tested and it was positive. She got the vaccine on the 23Dec2020 Wednesday then on 24Dec2020 at night she passed out and on 25Dec2020 she was disoriented all day. Investigation Assessment: No. On 24Dec2020 she was going to bathroom, and found herself on the floor, then the following day 25Dec2020 was when she was disoriented. She knew this because when she had the actual COVID virus previous in Nov2020 this happened previously. When queried outcome of being disoriented she stated that she still felt a little weird but if getting better very, very slow. The Second dose was schedule for 13Jan2021. Caller confirmed that she did have a Positive Test for Covid Previously. Her treatment at the time was in the Emergency Room, they gave her an Antibody infusion, she had to schedule it because it was actually a clinical trial. Caller was asked if she knew the name of covid test, she stated that she does not know, she only recalled that she opened her mouth and they test her that way. The outcome of the event "disoriented" was recovering, of the other events was unknown.
My shot was 11 am 2/12.  By 5:30 I was achy and tired.  By 9 pm I was running a temperature of 101. I took tylenol and went to bed.  I woke with a temp of 103 and incredible body aches and chills. The temp, aches and chills continued through the evening of 2/14. My temp ranged from 101 to 103 while on Tylenol.  By 2/15, I felt mostly well, just some residual fatigue.