chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable physician. An 18-year-old male patient received TRUMENBA (Lot Number: S56026, expiration date: 28Feb2019), via an unspecified route of administration on 01Aug2018 at 0.5 mg, single for immunization as he was going off to college and living in the dorm. Medical history included anxiety and ADHD. The patient's concomitant medications were not reported. The patient received a previous dose of TRUMENBA in Oct2017 for immunization. The patient received meningococcal group b rlp2086 on 01Aug2018 and the next day (02Aug2018), the patient started with fever, nausea and weakness. On Friday (03Aug2018), he was red from head to toe. He continued to feel weak and nauseous. The patient had now started with psychiatric symptoms, more of a psychosis on an unspecified date in Aug2018, reported as 2-3 days ago. The physician stated that before the vaccine, the patient was a healthy person, getting ready to go off to college. The psychiatric symptoms were getting worse. The physician sent him to the emergency room to be evaluated for a possible concomitant infection or drug exposure. The physician considered the event of psychiatric symptoms, more of a psychosis as serious (life threatening). The physician assessed the events of fever, nausea, weak and red from head to toe as non-serious. The patient recovered from the event of fever on 03Aug2018. The patient has not recovered from the events of nausea, weakness and psychiatric symptoms, more of a psychosis. The patient was recovering from the red from head to toe event as the redness was now only on his knees, elbows and knuckles. The physician considered the events of red from head to toe and psychiatric symptoms, more of a psychosis as related to meningococcal group b rlp2086.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
The adverse events began one day after the 1st dose of the vaccine series.  The adverse events include: diarrhea, frequency, abdominal cramping, and nausea. The patient sought treatment after 2 weeks of symptoms. The physician diagnosed the patient  with infectious diarrhea and prescribed a 3-day course of Cipro 500mg BID. The symptoms improved but the patient continued to have some GI symptoms remaining. The symptoms worsened after the second dose of the vaccine series. The patient went to the doctor on March 1st and received another course of Cipro 500mg BID but for a 5 day course. The patient is currently completing the antibiotic course.
4 hours after administration of shot, mom noted infant to be sleepy then limp and blue, mild shakiness; then responded to stimulation. Event reoccurred 2 times after within a 30 minute period. 911 was notified and infant was taken to ER.
Severe complete body aches/pain, lightheadedness/headache, stomach, insomnia (due to severe aches/pain?). Eased  after taking 2 extra strength Tylenol, every 4-5 hours.
Hives on right calf & behind right knee, left knee and left arm close to injection site / More hives (right & left arms and right hip).; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 11:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis spinal, spinal stenosis, spinal stenosis, neuralgia and drug allergy to sulfa drugs, penicillin and tetracyclines. Concomitant medications included pregabalin (LYRICA), celecoxib (CELEXA) and camphor, diphenhydramine hydrochloride, zinc oxide (BENADRYL), all taken for unknown indications from unknown dates. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 11:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 09:00, approximately 19 hours after the vaccination, the patient experienced hives on right calf and behind right knee, left knee and left arm close to injection site. On 02Apr2021, second day after the vaccination, the patient had more hives on the right, left arms and right hip. On 03Apr2021, third day after vaccination, the patient had more hives, the hives were red swollen and itchy, but not severe. Therapeutic measures were taken as a result of the events and the treatment (by self) included Over The Counter (OTC) benadryl, hydrocortisone cream and 91% isopropyl alcohol. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event hives on right calf and behind right knee, left knee and left arm close to injection site, more hives on the right, left arms and right hip and the hives were red swollen and itchy were resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Arm achy (arthritic-like pain) from shoulder to hand. No bruising. No numbness. Ibuprofen helps but does not completely remove pain. Still in pain 3 months later.
Extreme lethargy, inconsolable crying, gastrointestinal issues for weeks, and behavioral changes.
12 YEAR OLD PATIENT WAS GIVEN MODERNA VACCINE. NO ADVERSE EVENTS REPORTED.
no additional information provided; patient was administered a third dose of Varivax on 5JAN2022; she received her 1st dose of Varivax on 18 OCT 2007, and second dose on 26 NOV 2007; This spontaneous report has received from a physician referring to a 9-year-old female patient. Concomitant medication and pertinent medical history were not reported. There were no known drug allergies.  On 18-OCT-2007, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 mL subcutaneously for prophylaxis (strength, lot#, and expiration date were not reported).   On 26-NOV-2007, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, lot#, and expiration date were not reported) (inappropriate schedule of product administration). On 05-JAN-2022, the patient was vaccinated with the third dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# U008180, expiration date 12-MAR-2023; strength was not reported) (extra dose administered). No additional information or adverse event (AE) was reported.; Sender's Comments:  US-009507513-2201USA003547:
On 06/01/2000 the patient developed a fever of 101.2F and on 06/02/2000 was diagnosed with 40-50 varicella lesions and a fever of 101.8. The pox were 1/2 cm in size with erythema surrounding.
4 mo male infant with history of bowel resection and ECMO, vaccinated with ROTATEQ dose #2 on 3/25/10 under FDA IND protocol 13843. Parent phone by PI on 3/28/2010 and mother reported that infant had been "fussy" for most of the day after the vaccine was given, 3/26/10. By "fussy" she stated that he did not want to take his nap. All symptoms had resolved by 3/27/10, per the patient's mother.
47-yr old female received injectable on 9/27. 2 hours post vaccination patient developed a rash. Patient sought medical care at occupational health; was not hospitalized or diagnosed. Was given steroids and stated the rash improved. C/o hives starting within 2 hours of vaccine and lasting 36 hours after vaccine in upper torso as well as arms and legs but not on face. 1 day later, pt. experienced chills. C/o chills starting around 4 hours after vaccine lasting about 3 hours. Both episodes lasted 2 days. Spoke with participant on the phone, stated she has never had an allergic reaction with a vaccine before.
A healthcare professional reported that a 78 year old male, with a history of myelodysplastic syndrome received an injection of Flu Shield on an unspecified date. Concomitant therapy included Flomax, aspirin, Cardizem, Procrit, and Cipro. On 10/16/02, the pt was hospitalized with chills, fever and shortness of breath. It was later determined that the pt experienced an exacerbation of yelodysplastic syndrome. Lab test results were not provided. The pt also stated he developed renal failure. According to the pt, his attending physician felt the "exacerbation of myelodysplastic syndrome may have caused renal stone (calculus renal nOS) which in turn caused hyperkalemia and renal failure." The pt's experience of renal stones and hyperkalemia leading to renal failure was considered medically important (OMIC).
Patient went to bed feeling very cold, then woke up at around 4am feeling very warm, dizzy, and could not stand. Patient claims to have felt feverish at this time. Patient also said there was a very large bulge at the site of the injection. Next day, patient felt better, though not fully recovered, and arm was still warm to the touch. Patient returned to pharmacy on day 3, and upper arm was still pink, though he said he felt better today. Patient said symptoms are slowly abating, but said he has never had this severe of a reaction to a vaccine before.
Patient fainted while sitting in the waiting area about 5 minutes after receiving her first dose of the Pfizer COVID Vaccine.  Patient was unconscious briefly, but woke up after less than a minute a little disoriented.  She was sweating and felt very hot, except for her hands that were cold.  We gave her water and an ice pack to cool her down and waited with her until paramedics came to treat her.  She seemed alert and that the issue had mostly resolved as she left with paramedics approximately 15 minutes later, but it is unknown what happened after she left with them.
Very swollen, red, hot area encompassing whole upper arm from shoulder to elbow. Extreme pain, fever. Follow up: Reporter states diagnosis was cellulitis of the right arm.
swollen, red arm. Fever, Chills, Body Aches, Stiff neck/back,headaches. Severe fatigue over the course of 24-72hrs.
Case PHEH2016US022328, is an initial report received from a consumer via patient oriented program on 31 Aug 2016. This report refers to a 62 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with influenza vaccine (unknown whether seasonal or pandemic, batch number: not reported) on an unknown date. The patient stated that, while on HUMIRA she took the flu vaccine and ended up getting the flu, the H1N1 strain. She ended up in the hospital with pneumonia and her healthcare professional decided not to use HUMIRA any longer. Her healthcare professional would start her on COSENTYX hoping that she may not get any secondary infections as she was infection prone. The outcome and causality of the events was not reported.
long covid; reaction to the vaccine; Initial information received on 05-Nov-2021 regarding an unsolicited valid non-serious case received from an other health professional via Media Information (under the reference 00844978).  This case involves a female patient (unknown age) who had long covid (coronavirus Disease) [post-acute covid-19 syndrome] and reaction to the vaccine (adverse reaction) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect FLUZONE QUADRIVALENT (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious long covid (post-acute covid-19 syndrome) and reaction to the vaccine (adverse reaction) (unknown latency) following the administration of vaccine.  It was reported "Caller is a patient and a nurse. Caller says that she is currently dealing with Long Covid. She wants to find out the ingredients in FLUZONE HD and if it contains any Hexabromocyclododecane (HBCD) or Polysorbate 80. She also mentioned that she had a reaction to the J&J vaccine. Caller also wanted ingredient information for regular FLUZONE."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There would be no information on the batch number for this case.
I previously had COVID-19 early last August. I had all the symptoms and had a fever around 99-100 for many days in a row. I also got the coughing towards the end of Covid and then had Covid pneomonia and was hospitalized for 4 days as my body just needed oxygen. I was hoping to take the vaccine so I wouldn't get the full Covid illness again. I took my first dose of the vaccine Wednesday morning, 4/21. I only felt tired Thursday morning, 4/22 however by middle of the afternoon I began to have shivers and was very cold. As the night went I was feeling terrible and had first seen a 104 temp but thought I took it wrong. Later took my temp again and was 102.5. After taking some ibuprofen my temp went down to 99.8. I had terrible leg pain and restless legs and couldn't get comfortable the entire evening, full body was in pain. It was worse then having actual Covid, I've never had my body feel that bad before but very glad it was for a shorter time period. Very sore and stiff, almost as if I couldn't get up to use the restroom. I was sleeping in and out (trying atleast) and woke up with night sweats around 11pm. I do think my fever had finally broke around then. I was in communication that night with my friend who is a nurse and we both hoped I would be better by the next morning. Thankfully I did sleep the rest of the night and only felt very tired and exhausted Friday & Saturday. Friday, it was still hard to get out of bed, alot of soreness but glad the fever was done. Saturday was better just tired and started to feel almost back to normal again on Sunday (5 days post my 1st vaccine dose) just still tired even today on Monday, 4/26.
This case was reported by a other health professional via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy student. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The health care professional did not have any further information. The health care professional reported that, this happened at a different pharmacy location and that the other location would probably call in regards to this as well.
3 days post vaccination, the pt experienced redness at the site and soreness. the pt sought unspecified medical attention. Additional information has been requested.
I have experienced two episodes of dizziness with sudden onset. The first hit me suddenly while sitting at my desk and the second while I was in the cockpit of an aircraft. The second episode felt like the aircraft had fallen on its side. The second episode being more severe than the first. An immediate change in axis it seemed. Both episodes left me nauseous with mild sweating. I experienced nausea and fatigue lasting between 24-48 hours afterwards. There was no chest pain or palpitations. I did have a lingering headache after each episode of dizziness. I was evaluated at an UTC after the first episode. I was treated with Meclizine but it has not alleviated the symptoms. I followed up with my doctor who advised symptoms were not associated with BPPV or vertigo.  Requested an MRI of the brain which was completed and was unremarkable.  The dizziness has continued since the onset of symptoms above.
Severe chills 5 hours later.  In spite electric blanket, heavy blankets and fully dressed, I could not get warm for several hours.  I turned off electric blanket after 3 hours and removed heavy quilts.  I woke up several hours later in a heavy sweat-enough to soak pillow, pajamas and bedding.
Fever and sore throat. Increased WBC admitted to hospital x 24h. Released on antibiotic illness not thought to be related to vaccine.
This spontaneous case reported by a consumer, describes the occurrence of limb injury (stubbed foot; swollen/painful), swelling (stubbed foot; swollen/painful) and pain in extremity (stubbed foot; swollen/painful) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No reported medical history. On Apr 13, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced limb injury (stubbed foot; swollen/painful), swelling (stubbed foot; swollen/painful) and pain in extremity (stubbed foot; swollen/painful). At the time of the report, limb injury (stubbed foot; swollen/painful), swelling (stubbed foot; swollen/painful) and pain in extremity (stubbed foot; swollen/painful) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Treatment medication not reported.
Expired vaccine administered to patient; Vaccines administered after being in stored in fridge past 30 days; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (No adverse event) in a 92-year-old 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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second 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 (Expired vaccine administered to patient), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730541:Same reporter
The patient received the bivalent pediatric covid vaccine when the patient should have received the monovalent pediatric covid vaccine.
ringing in ears; shortness of breath; "face doesn't look right"; "started to not feel well"; nauseas; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in ears), DYSPNOEA (shortness of breath), FACIAL PARESIS ("face doesn't look right"), MALAISE ("started to not feel well") and NAUSEA (nauseas) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure, COPD and Lichen planus. Concurrent medical conditions included Ragweed allergy, Penicillin allergy and Allergic reaction to antibiotics.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced TINNITUS (ringing in ears), DYSPNOEA (shortness of breath), FACIAL PARESIS ("face doesn't look right"), MALAISE ("started to not feel well") and NAUSEA (nauseas). At the time of the report, TINNITUS (ringing in ears), DYSPNOEA (shortness of breath), FACIAL PARESIS ("face doesn't look right"), MALAISE ("started to not feel well") and NAUSEA (nauseas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided
This spontaneous report as received from a nurse refers to a patient of an unknown age and gender. The patient's medical history, concurrent condition and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD lot# N034561, expiration date: 03-JUN-2019 or lot# N025926, expiration date: 18-MAR-2019 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent (MERCK) for prophylaxis. Administered dose of vaccine experienced the temperature excursion between -14 degrees Celsius to -10 degrees Celsius (also reported as -10.4 degrees Celsius) for 1 hour and 3 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse events were reported. This is one of four reports received from the same reporter. Lot numbers N034561 and N025926 have been verified to be valid lot numbers for measles, mumps, rubella and varicella (oka-merck) virus vaccine live with albumin status rHA. Sender's Comments: US-009507513-1806USA004463: US-009507513-1806USA004465: US-009507513-1806USA001112.
Breakthrough case admission after 3 vaccines Moderna 2/27/21 Lot# 010A21A;  Moderna 3/27/21 Lot# 002B21A;  Moderna 1/8/22 lot# 028K21A
Patient stated from her elbow up to her shoulder has been swollen and red rash looking--she compared to it to redness like a sunburn. Patient also stated it itched and was painful at times. Has experienced dizziness as well as nausea. Wasn't bad the day after but has progressed becoming worse over past 2 days.
Covid vaccine x 2 in 2021. Tested positive for Covid on 8/15/2022. Admitted to the Medical Center on 8/15/2022. Expired on 8/20/2022 while still hospitalized.
The day after receiving my first dose of the Pfizer COVID-19 I started to develop deep blood blisters on my toes. There was about 3-5 between both of my feet; progressed and started to lessen over the next month. Same thing happened after my 2nd dose but exacerbated the blisters that were there prior and got and additional 10+ blisters. No treatment and they eventually dissipated after 1.5 months.
Pt presents with a large area 11x7.5cms of erythema and edema. No fever; local pain. It overlies L shoulder and upper arm. No LOM; no compromise of circulation or sensation to the extremity. Playful, eating well, being his usual self. Started him on Cephalexin and Ibuprofen. F/U 8/23/02. and 8/26/02 by phone: much improved.
Moderna COVID-19 vaccine mistakenly administered to a 16 year old. Patient was monitored for recommended time. No adverse events noted.
Pressure on  the chest, labored breathing, hives  on neck, upper arms, back
Redness and painful lump in area of injection. Will be taking BENADRYL during non-working hours.