chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist and described the occurrence of leukemia in an adult female subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis. Concomitant medications were unknown. At an unspecified time the subject received a "series" of Hepatitis B vaccine (unknown). At an unspecified time after vaccination with an unspecified dose of Hepatitis B vaccine, the subject experienced not responding to therapy. A pharmacist reported that titers were taken from the subject (dates unspecified), which revealed that the subject did not respond to therapy with Hepatitis B vaccination. In addition, the pharmacist reported that the subject developed leukemia. It was unknown if the subject developed leukemia before or after vaccination with the Hepatitis B vaccine series. This case was assessed as medically serious. At the time of reporting the outcome of the events was unspecified.
Information has been received from a pharmacy technician and a licensed practical nurse concerning a patient (age and gender not reported) who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. It was reported that the patient experienced a "similar reaction" such as warmth and redness at the injection site. However, the licensed practical nurse stated that she could not supply further details, lot number, severity and exact symptoms. The pharmacy technician noted that "it seemed like more patients had this experience this year that patients who received the vaccine last year." Additional information is not expected.
A couple of weeks after receiving the vaccine I noticed on my right arm I developed some pimples that were itchy. I called my dermatologist after a couple of weeks of the itching as it was persistent and did not go away. We scheduled a video call after I had sent him picture. He said he was finding that more and more patients were coming in this reaction after receiving so many vaccines in such a short time. He did prescribe triamcinolone 1% cream for me to use on the areas and told me to contact him if it does not clear up.
Migraine; light sensitive; Extremely nauseous; Extremely dizzy; Headache; This is a spontaneous report from a contactable consumer. This consumer reported similar events for herself and her husband. This is 2nd of 2 reports.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced migraine, light sensitive, extremely nauseous, extremely dizzy, and headache but he was able to sleep at night. (These events were reported as "similar side effects" with the patient's spouse.). The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021477842 same reporter, drug, and event, different patient
Fever up to 103.3  within 24 hours of 2nd set of immunizations
Patient received Varivax on 12/9/1999. She developed a papular, pustular, crusted rash on warm trunk areas. It crusted in two days. Sibling had similar rash.
Information has been received from a medical assistant referring to two unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L034367, expiration date 08-SEP-2017; dose and route were unknown). No adverse effects were reported. The excursion temperature was 9 Fahrenheit degree for 4 hours. Data logger was involved. There was no previous excursions. Product quality complaints was not involved. Additional information has been requested.
Patient did not experience an adverse event.  Patient's 1st dose of the COVID-19 vaccine was Pfizer.  2nd dose should have been Pfizer also, but Moderna was administered in error.
While patient was waiting in the waiting area in the pharmacy after the vaccination he started showing signs of syncopy , he was little pale and diaphoretic and his head was falling onto his chest .So I took him to the consultaion room where he lied down on the floor for few minutes
Patient reports increase pain on movement of left arm followed by numbness and tingling to left arm. Pt reports she did become sick with flu-like symptoms and did take Theraflu and Alka-Seltzer on 29 November 2014 (two days ago).
skin sensation change, diffuse diffuse pain across body,, all day multiple joint pain , all day
Patient a 15 year old teenage male had just been vaccinated for the first time with the HPV Gardasil 9 Vaccine. Approximately 5 mins later, while at checkout patient started violently shaking and collapsed onto the floor at the Pediatrician's office with continued shaking and passed out briefly. Patient hit the back of his head on the floor. Patient had just been given a "clean bill of health" from his 15 year old physical.
Received vaccine at 3 pm. Feeling fine until 1520, noted some chest tightness and shortness of breath. Denied trouble swallowing; sipping apple juice. Notes of late being tested for low blood sugar issues; no diabetes. HR 105, BP 118/74, p ox 98%. Additionally feeling hot. Transferred to wheelchair; feels weak, shaky.  With chest tightness, called Rapid Response; patient agreeable to ED evaluation. Notes having to breathe a bit more deeply to help breathe. Transported to ED by Rapid Response team.
body aches (like growing pains in the joints); I was fatigued; Arm where vaccine was given was sore; I was very cold; swollen lymph node in the armpit of the arm where vaccine was given.; Chills lasted until about 24 hours after vaccine was given; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old adult female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL 9264), via unspecified route of administration in the left arm on 05Feb2021 at 06:30 PM, as single for COVID-19 immunization at Public Health Clinic. The patient's medical history included hypothyroidism, high cholesterol, acid reflux, gallbladder stone, overweight and seasonal allergies that last all year. The patient was not allergic to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), omeprazole, montelukast sodium (SINGULAIR), levocetirizine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: E13247), via an unspecified route of administration in the left arm on 14Jan2021 at 06:30 PM, as single dose for COVID-19 immunisation. On 06Feb2021 at 07:30 AM, 12-13 hours after the vaccine: body aches (like growing pains in the joints), she was fatigued, was very cold. Arm where vaccine was given was sore and swollen lymph node in the armpit of the arm where vaccine was given. Chills lasted until about 24 hours after vaccine was given. Body aches went away about 30 hours after vaccine was given. Swollen lymph node still swollen 2.5 days after vaccine. Took Tylenol about 19 hours after vaccine and it seemed to take the edge off the aches. Took 1 more dose of Tylenol 6 hours later and that's all she needed. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events body aches (went away about 30 hours) and chills (was lasted until about 24 hours) was recovered on 07Feb2021; swollen lymph node was not recovered; for rest of events was recovering.   Follow-up attempts are completed. No further information is expected.
Started having swollen in throat and tongue, fatigue, Covid-19 arm, swollen lymph node on left arm and leg, headache.
flu like symptoms; Body aches; fever; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (Body aches) and PYREXIA (fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M21A, 046C21A, 025J202A and 025J202A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (Body aches) and PYREXIA (fever). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (Body aches) and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that patient received Pfizer Bivalent Booster on 20-SEP-2022, lot number G9694. No treatment medication was reported.   Reporter did not allow further contact
Severe tenderness at injection site, high fever, chills, nausea, vomiting, fatigue, body aches
4 Hours after the vaccine, I started feeling run down. Very tired. I went to bed early and I woke up at  3:56am with a fever and a headache and chills that lasted an hour. I took tylenol and I fell asleep til about 11:30am or 12pm. I still have an annoying headache above my eyes. I dont have an appetite either. My eyes feel a little hot and I am exhausted.
Sore stiff legs, shoulders, arms and hands. Problems walking first thing in the morning.
drug is supposed to be SQ, i gave IM, that is the event i'm reporting. pt reports to be a little sore.
7.11.21: Patient presents to the ED with fatigue, dyspnea, cough, and malaise. found to be COVID-19 positive. has a history of receiving both doses of Moderna COVID-19 vaccine. diagnosed with Pneumonia. Found unresponsive during CTA of chest. Then coded in the ED. transferred to the ICU. 7.12.21: rapid response called for respiratory distress. intubated. started remdesivir. received 1 dose of tocilizumab. 7.16.21: patient still admitted as of today - the day of report submission. still intubated. completed 5 day course of remdesivir.
There is a red, raised, itchy bump at the injection site. It?s hot to the touch. It started out the size of a dime, now at 6:18pm it?s a size of a quarter.
New onset severe headache and vomiting 48 hours post-vaccine. Duration of vomiting approximately 6 hours. Duration of headache approximately 36 hours but did improve gradually after 12 hours. Unsure about fever as I was dosing with anti-pyretics for headache, but did experience sweat overnight.
Pt received MMR in lateral (R) thigh, developed a red, raised welt at the injection site after 25 minutes. Mother states three days elapsed before swelling started to go down, although Motrin given and cold packs applied. "Bruised" appearance at the site did not begin to resolve until 12 Feb 08.
Tested positive for COVID-19 after receiving both doses of  Pfizer vaccine. Breakthrough case.
Presented with SOB and covid sympoms x 10 days; + test PTA 8/22; dx & admit with Covid PNA; tx with Vit C, baricitnib, Vit D, steroids, maxipime, doxycycline, rocephin, zinc; intially required high flow O2; currently remains on continuous Bipap; desats quickly when removed; on 100% FiO2 He also became hyperkalemic due to AKI. I discussed his prognosis with his wife and children and they requested comfort care and withdrawal of artificial support. This was done and he died at 10:17am on 9/21/2021
This spontaneous report was received from an administrator via a field representative referring to a 59 years old female patient. Information about concurrent condition, concomitant medication, medical history, drug reactions or allergies was unknown. On 22-OCT-2020, the PNEUMOVAX 23 shipment was received a day late (expected arrival date was 21-OCT-2020, product shipment delay) to the reporter's practice, they were not viable for use, and someone in the office mistakenly placed them in the vaccine fridge (confliction information: the box of vaccines got placed into a refrigerator at recommended storage range once received). On 23-OCT-2020, the patient was vaccinated with a dose of PNEUMOVAX 23 (0.5 ml, lot # T020638, expiration date 26-FEB-2022; route was not reported) for prophylaxis (improper storage of product in use).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020638; expirationdate: 26-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2011USA015361: US-009507513-2011USA015362: US-009507513-2011USA015363: US-009507513-2011USA015360: US-009507513-2011USA015358: US-009507513-2011USA015357: US-009507513-2011USA015359:
Patient received 1st booster dose of Moderna COVID-19 Vaccine (1st dose: 8/12/2021, 2nd dose: 9/10/2021) at approximately 10:30 am 5/12/2022. Patient reports a temperature at 7:30 pm of 102 degrees Fahrenheit. Patient got up from bed at 3:00 am on 5/13/2022 to take more acetaminophen 325mg tablets for fever and fainted in home while obtaining. Fellow occupant in home assisted patient to sitting up, where patient proceeded to immediately faint again, no injuries sustained during either fall. Patient was revived without incidence and recovered in bed. Patient states they have not fainted before after any previous vaccine including primary COVID-19 vaccination with Moderna and sought out advice from pharmacy on how to proceed.  Pharmacy encouraged patient to continue to monitor fever and lower/contain temperature by taking acetaminophen on a scheduled dosing regimen. Pharmacy also encouraged patient to reach out to primary care facility for follow up regarding fainting spell. Patient does report running temperature after both doses of primary Moderna COVID-19 vaccination, minus fainting.
pt first set immun, ext morning parents noticed cont muscle jerking over entire body, was brought in 2 days later w/cont but dec muscle jerking & hypertonic reflexes;
There was no adverse event but the vaccine was given to a patient that was under the recommended age of 18. Our appointment system is flawed and allows patients under 18 to register for the Moderna and Janssen vaccines so this is something we missed when verifying the patient's DOB. Upon calling the patient the patient's father, father said the patient feels fine with no issues at this time. I advised that they reach out to the patient's primary care physician or visit and Emergency Room if the patient's health situation changes. I also, informed them that we made a mistake and that the patient should not have gotten a Janssen vaccine due to him being under 18 years of age.
pt recvd vax; devel red bumps over legs, backs, arms;seen at md ofc w/ continuation of rash which was then vesicular;tx w/ dph;afebrile & was not ill except for head lice which was tx w/ permethrin
*ADMINISTRATION ERROR*   77 Y/O MALE PATIENT RECEIVED THE VACCINE BEFORE RECOMMENDED TIME OF 4 MONTHS BETWEEN DOSES, AS ESTABLISHED BY CDC. FIRST BOOSTER DOSE WAS ON 1/18/2022 AND HIS VACCINE WAS 04/01/2022
Numbness and tingling on right side of body, onset < 24 hours after vaccine was administered. Equilibrium affected. Treated at hospital ER and admitted. Acute ischemic VBA thalamic stroke.
9:55 am Participant, while waiting in the post-vax area, asked area monitor for water.  She stated that she felt warm.  Complained of lightheadedness.  No nausea, difficulty breathing.  Monitor provided her a bottle of water and asked EMS who was on standby in the area to take her blood pressure (115/67, pulse 72).  10:30 participant informed EMS that she felt fine and EMS offered to wheel her to her friend's car.  PHN briefly met participant and she stated, "I'm feeling fine."
8-10 after you vaccine, I got hives and went from the elbow up, and it is still on going. it was really bad for the first couple months but after i stopped scratching and put ice packs on arm. the hives would become welts and would start bleeding.
Fever of 100.2 orally. Right deltoid mildly swollen, diffusely red and mildly warm, tender. Redness had slight turn towards the forearm of the deltoid. Reported numbness and weakness and wasn't able to fully squeeze (R) hand. Pt. given 60 mg TORADOL inj. in clinic. Sent home w/oral TORADOL, PERCOCET, prednisone, ZOFRAN.
Tdap and Varicella administered while she is pregnant. 16wks. EGA.
Patient is a 68 y/o female who enrolled in program on 9/19/2018 who began monotherapy treatment with Pioglitazone 15mg PO on 10/5/2018. Patient called study team stating that she received her second Pfizer COVID-19 vaccination on 02/19/21.  Afterwards, she had a sore arm and slept most of the next day.  On 02/21/21, she experienced severe right-sided leg weakness and fell while attempting to go to the bathroom.  She was unable to ambulate and her son took her to the emergency room. She was hospitalized overnight for a serious adverse reaction to the second Pfizer COVID-19 vaccination.  Multiple sclerosis exacerbation was ruled out after extensive testing. Then, she was transferred a Rehab facility on 02/22/21 for physical therapy and occupational therapy.  She continues study medication without any missed doses.  She will most likely be in Rehab for another week.  She was able to walk 80 feet on 2/25/2021 with a walker and gait belt and ambulatory assistance. This is unrelated to study drug. We consider this to be a Non-UP SAE.  As of 3/4/2021 the patient is still in rehab.
Got dizzy spell and fell on 24th. I took some of my wife?s meclizine and promethizine for dizziness and nausea and is helping.
Information has been received from a licensed practical nurse concerning a 5 yr old male with no medical history or allergies who on 12Nov01 was vaccinated with a first dose of varicella virus vaccine live. Concomitant therapy included sodium fluoride. On 12Jan06, the pt developed chickenpox with approx 30 lesion on the trunk, some open with fluid. The pt also had a fever to 101.4 deg F and a cough for the past four days (starting approx 09Jan06. Unspecified medical attention was sought. It was noted that he was not hospitalized, but was being treated at home with calamine (+) camphor (+) pramoxine hydrochloride (Aveeno) baths, diphenhydramine hydrochloride (Benadryl), acetaminophen (Tylenol) and albuterol. No diagnostic laboratory tests were performed. The pt was recovering. A product quality complaint was not involved. Follow up information was received from a physician who indicated that the pt was not vaccinated at her facility. On 12Nov06, the pt developed chickenpox despite being previously vaccinated. He was febrile and wheezing. A doctor visit was required. The pt recovered on an unspecified date. No further information is expected.
Injection site: swollen, red and hot along with pain/soreness. Symptom: fever, tired and severe headache.
About 4 days after receiving vaccine client stated he developed a fever and then on his left shoulder/back area he developed a large edematous area which he described as the size of half an orange, He denied redness but stated it was tender to touch and when he moves his arm he stated pain shoots down the left arm.  He did not report this till receiving second dose 3/17 and there was still an area of the shoulder the edematous area was still palpable. and was the size of a golf ball.
UNDERDOSE; This spontaneous report received from a pharmacist concerned a 52 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042121A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 14:20 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced under dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of under dose was not reported. This report was non-serious.
I came down with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-OCT-2022. Reporter's comment: This case was reported by the reporter via interactive digital media. The reporter stated that he/she had taken the first dose of Shingrix but before he/she could take the 2nd dose, he/she had come down with shingles. The reporter had also asked if, he/she should wait before taking the second dose. Additional supportive information: Follow-up would not possible, as no contact, details were available.
01/04/2021 9am - vaccine administered - felt fine, went climbing. 3pm mild fatigue began. 6pm injection arm was practically unusable, had to get help to undress, extreme chills with trembling that made it difficult to breath. Hands turned pale and where hard to use. 8:30pm fever reached 103 F and extreme body aches and joint pain began. Splitting headache also began. The trembling stopped but a dry cough began. Between 8:30pm and 11pm fever fluctuated wildly from 101 F  into the 103  F until at 11pm the fever reached 104 F. 11pm Fever peaked at 104 F, took two advil and a cool shower as my brain felt like it was on fire and I had the worst headache of my life. I felt confused and disoriented.  With in minutes of taking a cool shower and putting icepacks on my neck and wrists fever dropped to 103 F range. 01/05/2021 Fever fluctuated in the 101 F- 103 F range until 4am, awoke with sheets completely soaked in sweat. 7am - 12pm fever stayed within 101 F range. Extreme fatigue, moderate joint pain, moderate body aches, moderate headache. Was unable to get out of bed without major effort. 7pm temperature returned to normal range 97.3 01/06/2021 8am moderate fatigue, felt confused, disoriented and dizzy. Arm was useable but very painful and ROM limited 7pm extreme fatigue 01/07/2021 10am extremely dizzy and disoriented temperature 96.9
Bad Migraine. Started as a headache a few hours after the vaccine. Turned into a migraine that feels like when I had a concussion. Migraine gets better and worse. Thinking, reading, going to class hurts my head so much worse. It?s now been over 3 days since the vaccine and it?s not going away. I?ve never dealt with migraines before except for one concussion 4 years ago.
6-8 hours later severe pain on shoulder started. Couldn't move area for about 36 hours so could hardly get out of bed. Still is sore, tender to touch, painful to rotate backwards. Put ice and tried taking TYLENOL but did not help. Nurse put it high in shoulder.
Patient was given covid vaccine BUD. Vaccine expired on 7/7/22 and was given to pt on 7/19/22