chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional via sales representatives and described the occurrence of diarrhea in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). In August 2009 (date believed to be 14 August 2009), the subject received unspecified dose of BOOSTRIX in the left deltoid. On the same day of vaccination, the subject developed diarrhea, vomiting and low blood pressure. The events were resolved at the time of reporting. Relationship of these reported events to BOOSTRIX was unknown.
1st dose Moderna rec'd on 7/13/21. Patient returned on 7/29/2021 reporting  whelps that come and go since 1st dose. Patient thought was bug bites. Treated with decadron injection (4mg), zyrtec 10mg daily and benadryl 50mg at night as needed. 2nd dose vaccine of Moderna rec'd on 8/11/2021 (lot#046A21A given IM in left arm). On 8/16, patient returned to the clinic with complaints of whelps again (mostly at night). Patient was still taking the zyrtec and benadryl that was rx'd after the 1st dose. Patient was RX'd hydrocortisone cream 2.5% to include for treatment.
Not an adverse event other than contracting COVID on date cited as first date of positive antigen test. Symptoms: Fatigue, decreased exercise tolerance, bronchial congestion, nasal congestion, mild fever: <100 Tested negative on Day 11. Some persistent upper airway  congestion
Swelling, redness, warmth, pain in right thigh.  Swelling extended down past knee.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An adult male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), 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), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.
left deltoid significant erythema with spread of redness over time. Hard center where vaccine had been administered. Rx for Keflex and Septra started in the ED.
Very swollen and sore lymph nodes in armpit on the side the shot was given. Lasting for 5 days and counting. A very itchy rash with large bumps appeared on the arm where the shot was given 6 days after the shot.
Mother reports today 6/2/17 that patient has had a fever every day since vaccine was given. Last was today up to 101 degrees. Pt has scattered maculopapular rash to trunk and extremities. Concentrated rash to injection site of left lateral upper thigh.
Information has been received from a pharmacist concerning a 62 year old female patient with no drug reactions/allergies, who on 12-DEC-2008 was vaccinated subcutaneously on the right arm with a dose of ZOSTAVAX (Oka/Merck) (Lot # 662996/1618X). On 13-DEC-2008 the patient developed an irritating/itchy rash on the right arm at the injection site and on the right shoulder. The patient reported the rash to the pharmacist during a follow-up phone call. VZV analysis offered. Pharmacist said it was not his call and that the rash was not vesicular. It is unknown if the patient sought medical attention.  At the time of reporting, the patient had not recovered. Additional information has been requested.
Per nursing facility report, the patient tested positive for COVID19 today. They were concerned for increased dyspnea and wheezing and they noted the patient had some episodes of hypoxia to mid-70s on her oxygen and so they sent her to the ED for further evaluation. Patient reports some headache and mild abdominal pain. No nausea/vomiting. She has been acting her usual self per nursing facility staff.
Dizziness, feeling woozy, blurred vision, myalgias, numbness, tingling, weakness, cold sweats,
2-3 minutes after receiving vaccine injection site was itchy and red with hives. Throat felt itchy, tongue felt full and itchy. Took BENADRYL x2. 4 hrs later hives spread to neck face and scalp, resolved after first dose of BENADRYL but returned when dose wore off.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Dec2020 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 14Jan2021 at 15:00 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NUVARING, start date: 01Jun2022; FLUOXETINE, start date: 01Jul2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had treatment of Paxlovid on 13Jun2022 for COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician concerning an 84 year old male with and lumbar spinal stenosis and a history of neuropathy and foot drop who on 11-AUG-2010 was vaccinated with ZOSTAVAX (Oka/Merck) (lot number not provided). On approximately 25-AUG-2010 (reported as "about 2 to 3 weeks later") the patient developed a hyperpigmented, maculo-papular rash on one leg. The patient reported stinging pain that run along the veins in the leg, as well as itching and swelling. The patient was referred to a dermatologist who did not think the rash was "varicella" related. Patient reported mental anguish, inability to sleep and requested tranquilizers for anxiety over the rash. Patient was started on a course of KENALOG spray and was taking 2 TYLENOL tablets one to two times daily for pain. At time of the report, the patient was recovering. Hyperpigmented, maculo-papular rash on one leg, stinging pain that run along the veins in the leg as well as itching and swelling, mental anguish, inability to sleep and were considered to be disabling by the physician. Additional information has been requested.
Guillain-Barre syndrome; Coma; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2021 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: GUILLAIN-BARRE SYNDROME (medically significant), outcome "recovering"; COMA (medically significant), outcome "recovering". Therapeutic measures were taken as a result of guillain-barre syndrome, coma. Clinical course: The patient regretfully reported that he/she received the Pfizer COVID vaccine almost one and a half years prior to the time of the report while working in the [country]. The patient developed GBS, which left him/her in a coma and paralyzed both hands and legs. The patient had only made a minor recovery after extensive medical treatments. As a result, the patient stated that he/she need to file a lawsuit against Pfizer for concealing these types of side effects from vaccine recipients.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
light headedness, arms/hands & feet falling asleep, lethargy, tingling lips and chin
Heat and erythema in area that PNEUMOVAX was administered. Swelling and pruritis also noted within 5 hours of administration. Pt treated with ZYRTEC and advised to return if symptoms continue or become worse.
Information has been received from a medical assistant(also reported as office manager) referring to a12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 20-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program (VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Sender's Comments: US-009507513-1704USA014784:
Within 30 minutes after Influenza vaccine given client complained of tachycardia, tongue and throat feeling "picky". Then throat felt thick and swollen.
The vaccine given was expired past the 30-day recommendation. At this time there have been no s/s of any adverse events.
2 MIN AFTER VACCINATION PT BECAME DIZZY AND REPORTS EXPERIENCING TUNNEL VISION. PT ASSISTED TO FLOOR BY STAFF. TRANSPORTED TO MED OBS AT 1348 VIA STRETCHER. PT PLACED IN TRENDELENBURG POSITION. VSS. PT STATES SHE IS FEELING BETTER. PT SLOWLY TRANSITIONED TO A FLAT, SITTING AND THEN STANDING POSITION WITH NO ISSUES. ALL SYMPTOMS RESOLVED. PT RELEASED BY SELF AT1421. PT ESCORTED TO EXIT BY STAFF WITH NO FURTHER ISSUES. VITAL SIGNS AS FOLLOWS: 1400 BP 127/80 HR 61 SPO2 98 1406 BP 131/81 HR 61 SPO2 98 1410 BP 124/66 HR 62 SPO2 98 1415 SITTING BP 124/75 HR 71 SPO2 99 1419 STANDING BP 117/80 HR 75 SPO2 99
Information has been received from the registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who on 20-FEB-2013 was administered a dose of GARDASIL (lot # 668261/1397AA and expiration date 09-APR-2013) that was exposed to temperature of 11 Celsius degree. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Pt stated he threw up starting the next morning and thinks it was from the vaccine- it eased up by the night time and feels fine today
About 20 min after vaccine i felt a slight thickening of back of tongue.came and went within seconds. i am conerned about second dose; This is a spontaneous report from a contactable Consumer (patient). A 70-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 17Jan2021 13:30 at single dose for COVID-19 immunization in hospital. Medical history included atrial fibrillation. Concomitant medications in two weeks included apixaban (ELIQUIS), metoprolol succinate (TOPROL XL), levothyroxine sodium (SYNTHROID), semaglutide (OZEMPIC).  There was no other vaccine in four weeks. The patient previously had known allergies to epinephrine. About 20 min after vaccine she felt a slight thickening of back of tongue. It came and went within seconds. She was concerned about second dose. The event onset time was also reported as 18Jan2021 13:00. The event did not result in emergency room visit or physician office visit. There was no treatment for the event. There was no covid prior vaccination or covid tested post vaccination. The event was resolved on 18Jan2021.   Information on batch/lot has been requested.
First 2 days could not get out of bed.  Temp of 103F with extreme waves of being hot and cold.  Extreme body aches/pain whether I moved or stayed still - it felt like my body was being kicked around like a soccer ball.  I felt nauseous and dizzy.  Hard time eating or drinking.   I could not sleep even though I was extremely fatigued.   I felt like my heart was racing too. Slightly alleviated with ibuprofen.  Injection site was extremely swollen, red, hot to touch and painful - the swollen red area extender down to my elbow and wrapped around my arm and felt tight.  I took theraflu tea and the symptoms subsided for the four hours it was in my system, and I finally slept.  The third day, I could get out of bed, but I felt as if I was extremely hungover.  The fourth day, I had extreme fatigue, and injection site was still red and swollen.  The fifth I felt better and it took about 2-3 weeks for the red site to slowly go down.
In the fall of 1999, the pt developed a "splitting" headache and an injection site reaction characterized by swelling, redness, hardness, and warmth. Later he developed malaise which lasted about 1 week followed by "mild" flu symptoms.
This spontaneous report as received from a physician and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of ROTATEQ, lot # L008054, expiration date 30-NOV-2016 (dose was not reported) were given to unspecified patients on unspecified dates. No adverse effects were reported. It was unknown if the patients sought medical attention. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
strong healthy active mom went into Afib passed 9 wks later....of the 50-60 ppl there 5 have passed since May.  (2 others currently in Hospital)
mo called 4PM to say pt had a lump on arm;told to use ice compress several mins 4x day & given APAP;that evening mom states t104 & arm swollen from shoulder to elbow;took to ER;MD states rxn to DTP;
11 days after my vaccination on April 20, 2021, I experienced swelling in my left arm approximately 3 inches below where the needle penetrated my arm for the COVID vaccine. The swollen area is oblong, about 3.5 inches on the longest side and 2.5 inches on the shortest side. The area is swollen (raised 1/8 of an inch), looks bruised in a reddish purple hue, is hot/feverish to the touch, is painful like a bruise.
Awoke feeling dehydrated and very thirsty.  One hour later experienced extreme nausea and vomiting followed by fever of 101.4 with chills/body aches and extreme fatigue. Symptoms decreased after one dose of OTC analgesics and continued to improve over next 48 hours.
rash at the injection site from that booster shot; Patient had increased blotchy, itchy, red rash on his face; Patient had increased blotchy, itchy, red rash on his face; Patient had increased blotchy, itchy, red rash on his face; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Patient had increased blotchy, itchy, red rash on his face), RASH MACULAR (Patient had increased blotchy, itchy, red rash on his face), RASH ERYTHEMATOUS (Patient had increased blotchy, itchy, red rash on his face) and VACCINATION SITE RASH (rash at the injection site from that booster shot) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Nasal polyps.    No Medical History information was reported.   On 25-May-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRURITUS (Patient had increased blotchy, itchy, red rash on his face), RASH MACULAR (Patient had increased blotchy, itchy, red rash on his face) and RASH ERYTHEMATOUS (Patient had increased blotchy, itchy, red rash on his face). On 04-Nov-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site from that booster shot). At the time of the report, PRURITUS (Patient had increased blotchy, itchy, red rash on his face), RASH MACULAR (Patient had increased blotchy, itchy, red rash on his face) and RASH ERYTHEMATOUS (Patient had increased blotchy, itchy, red rash on his face) had not resolved and VACCINATION SITE RASH (rash at the injection site from that booster shot) outcome was unknown.            No concomitant medications were reported. No treatment drugs were reported.  It was reported that patient had increased blotchy, itchy, red rash on his face.  The reporter's causality was not provided for the all events.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Had PENTACEL and PREVNAR on 3/22/19. Extreme fussiness immediately after receiving vaccines which lasted off on for the next 2 days. Slight increase in work of breathing and clammy to touch per mother.
Joint site pain and redness Arthralgias Cannot walk distances as she could before the second injection
Information has been received from a nurse concerning a 22 year old female who on 30-JUL-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). According to the nurse, the patient had no symptoms when she left the office after vaccination. On 31-JUL-2008 the patient experienced dizzy and fell in her closet when she woke up at 4:00 AM. Unspecified medical attention was sought. Additional information has been requested.
In April, I had liquid diarrhea and it was pretty much liquid diarrhea for 8 weeks. I couldn't eat anything, and I had to have a specific diet with bananas, rice, applesauce and toast, plenty of fluids and water. That's all I ate for those weeks. The doctor put me on 6 Pepto Bismol tablets. He didn't want to give me any severe things in the end. It was about 8 weeks and I had lost 14 pounds during this time. I also felt very nauseated at night. I never vomited or anything and it was all bowel related. And it was probably inflammation in that area. Food would go straight through me. I had stomach cramps and pain in the back. I was very weak and tired, and I wasn't eating much and losing weight and very fatigued. My doctor said it was colitis over the telehealth. I did go in for a test and a stool sample done at the local clinic and I had bacteria and they diagnosed with colitis. Two stool sample tests that confirmed colitis. 1st test looked for C-diff and colitis. The 2nd one confirmed that it was colitis. Since then, I've been doing okay.
Fine Rash/rash in her hair; This is a spontaneous report from a contactable consumer or other non hcp. A 95-year-old female patient (consumer) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via an unspecified route of administration, administered in Arm left on 11Feb2021 (age at vaccination: 95-year-old) as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via an unspecified route of administration, administered in Arm Right on 04Mar2021 as dose 2, single for covid-19 immunization. Medical history included ongoing food interaction. Concomitant medication included bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10), via unspecified route of administration from unknown date and ongoing at unknown dose and frequency for an unspecified indication; TREXAR Herb Type Pill, via unspecified route of administration from unknown date and ongoing at unknown dose and frequency for an unspecified indication. On an unspecified date in Mar2021, patient experienced fine rash/rash in her hair. Patient got the second shot, she didn't know that if she broke out in a rash she should get to the hospital or something. States she had a fine rash that started about two weeks after she got the shot. Patient started on her legs and then worked itself all the way up her body, but it was not all over her body at one time. Patient had rash in her hair. Unknown but probably in the morning when she got out of bed. States she has had the shingles before and she thought it was the shingles, located where shingles had been and assumed it was the shingles coming back, not severe but just itchy. The outcome was not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
patient called from urgent care where she was being  seen for itching/hives/swelling; she was told there not to get her second dose or any other covid vaccine
Pt. states her arm was hard to move for 3 days after vaccine. It is still hard to raise her arm over her head. She is unable to join her hands behind her back. She spoke with her MD here and elsewhere. She went for acupuncture in March. That helped some and the acupuncturist recommended she report her issues. We notified pt's primary MD.
Information has been received from a physician concerning a 29 week old patient who on 28-OCT-2008 was vaccinated with the first dose of ROTATEQ vaccine 2ml oral. On 09-MAR-2009 the patient would receive the second dose. No adverse effect reported. Additional information has been requested
Left upper arm redness, swelling, warmth + pain. C/O pain firm left upper arm to fingertips. Having difficulty lifting left arm. Reports feeling pain since she received injection & has had continuous tenderness and pain since 3/22/2004
I tested positive for COVID-19 on 05/03/2022. My case was moderate. I had some coughing, running nose, fever 103, toothache and fatigue. I am still feeling fatigue, running nose and cough. I called my doctor about my toothache and he prescribe me some antibiotics Amoxicillin. I ask my doctor for the antiviral meds but he wouldn't give me anything. I have had these symptoms for 8 or 9 days.
This case was reported by a consumer via GSK/market research programs and described the occurrence of frequent bowel movements in a female who received Rotavirus vaccine. On an unknown date, the patient received Rotavirus vaccine at an unknown dose. On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced frequent bowel movements and diaper rash. On an unknown date, the outcome of the frequent bowel movements and diaper rash were unknown. It was unknown if the reporter considered the frequent bowel movements and diaper rash to be related to Rotavirus vaccine.
Patient is 17 years, 11 months, and he signed up for Pfizer at intake, and during the injection time, changed his mind and requested the Moderna.  He is over 200 lbs, and appeared over 18, so the he was changed to the Moderna vaccine, but his age was not re-verified prior to receiving the Moderna Vaccine.    He had not adverse effects.  The error was discovered in the afternoon on date of vaccination.  His parents were contact and informed of error, and patient is doing fine according to dad.  They were advised to continue with his scheduled 4 week appointment to receive his second dose as scheduled.  His second dose will be give off label sine he will be a couple shy of his 18th birthday.  was informed who restated to complete the VERs report.  The error was documented in PrepMod, IIS 2 reporting system under notes which reports to the  system.