chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 75 year old female who on an unspecified date was vaccinated with Pneumovax 23 (lot # not reported).  Subsequently, the patient experienced injection site redness and swelling after receiving Pneumovax 23.  Medical attention was sought.  Subsequently, the patient recovered.  No other information was available at the time of reporting.  Additional information has been requested.
Feverish; Ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Feverish) and PAIN (Ache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) Unknown. On an unknown date, the patient experienced PYREXIA (Feverish) and PAIN (Ache). At the time of the report, PYREXIA (Feverish) and PAIN (Ache) had resolved.            No concomitant medications were reported.  The patient had no side effects on the first dose of Moderna but felt feverish and achy on second and third dose. It passed after about a day and was fine.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of pyrexia and pain was not provided with SKYRIZI(RISANKIZUMAB).  No treatment medications were reported.  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.
Caller reported that his sons both had sore arms; This is a spontaneous report from a contactable consumer or other non hcp. A 23-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6201; Expiration Date: unknown), dose 2 via an unspecified route of administration on left arm on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. Historical Vaccine included first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's concomitant medications were not reported. Caller reported that his sons are 23 and 25. Caller reported that both of his sons received both doses of the Pfizer Covid-19 vaccine.  Caller reported that his sons both had sore arms for about a day and that their pain went away immediately. The outcome of the events was recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Patient's pertinent medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (lot # N002202, expiry date: 04-NOV-2019; lot # N006321, expiry date: 08-NOV-2019) (dosing regimen and frequency unknown) which was reconstituted with properly stored sterile diluent for prophylaxis. No adverse effects were reported. The temperature excursion was 9 degree C to 25 degree C for 1 hour 35 minutes. The temperature excursion was detected by digital data logger. No previous temperature excursions were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000667: US-009507513-1709USA000705: US-009507513-1709USA000706: US-009507513-1709USA000708: US-009507513-1709USA000709.
About 5 minutes after Vaccination given, Employee experienced nausea and sharp H/A.  Denied SOB/Difficulty Breathing/heart palpitations. After 15 minutes, employee  stated symptoms had begun to resolve.  Employee was  returned to her work station when she began to feel lightheaded and "woozy." Also stated that heart felt like it was "beating faster."  Continued to deny SOB/difficulty breathing.  Employee was assisted to a lying position. Shortly after, her symptoms began to resolve and she stated she was feeling better and symptoms were almost gone.  When I called to follow up with her, she did state that she had some nausea/vomiting that night.
Progressive swelling, erythema, and tenderness of his left upper arm and left elbow. Admitted to hospital for left arm cellulitis and IV antibiotics.
Full body aches, joint pain, muscle pain, headaches, pain while breathing Prescribed steroids, pain medication, and hydroxychloroquine Lupus
I took the first Moderna dose on 3/18, the second dose was scheduled to 4/15 ( Patient missed the second dose); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I took the first Moderna dose on 3/18, the second dose was scheduled to 4/15 ( Patient missed the second dose)) in a female patient of an unknown age who received  .     The patient's past medical history included No adverse event.     On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I took the first Moderna dose on 3/18, the second dose was scheduled to 4/15 ( Patient missed the second dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I took the first Moderna dose on 3/18, the second dose was scheduled to 4/15 ( Patient missed the second dose)) had resolved.            This case was linked to MOD-2021-182590 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up information received on 27-MAY-2021. Updated reporter's address and contact information
Pt admit to hospital on 1/5/22 w/ pericarditis d/t COVID19. Pt received 1 dose of J&J on 4/7/21
Patient came in Thursday May 8, 2003 at 12:20 and explained that patient had bumped into door with her left arm and it was then when she noticed that her arm started getting red and later got worse.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-JUN-2016, the patient was vaccinated with a dose of improperly stored PROQUAD (lot # M010478, expiration date: 01-SEP-2017; dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was given Kinrix as their 5th dose Dtap and 4th dose of polio at age 7 years and 3 months
pt recv vax; 3 weeks later,devel diarrhea and pancreatic insufficiency; reporter noted that this experience was disabling;
PASSING OUT AFTER VACCINATION; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient passed out about fifteen minutes after receiving JNJ vaccine. It was reported that the pharmacist did not waited the usual fifteen minutes for monitoring after the vaccine administration and patient was walking around shopping when she fell and had hit her head on the floor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of passing out after vaccination was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220302794-Covid-19 vaccine ad26.cov2.s- passing out after vaccination.The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Information has been received regarding a case in litigation from a lawyer, an elderly male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 08-DEC-2011, at age 74, the patient was administered the ZOSTAVAX vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from his ZOSTAVAX use: Shingles. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Throwing up for almost a week, she's violently throwing up, can't hold anything down liquid or food; Severe pain; If you just touch her, her whole body is like on fire; Headache; Senses are magnified, her sense of smell is overwhelming. Her hearing, she is in tears because just somebody talking to her in a normal voice is like they are screaming at her; Can't taste anything; This is a spontaneous report from a contactable consumer, reporting on behalf of a friend (Patient) via India Call Centre. A female patient (Friend) of an unspecified age received second dose bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The Patient's Medical history included Blood cancer, Heart problems and concomitant medications included unspecified heart medications. The Patient received first dose of historical vaccine, bnt162b2 on an unspecified date for covid-19 immunisation. It was reported that the patient has been throwing up for almost a week, she was violently throwing up. She cannot hold anything down liquid or food. She has had severe pain like if you just touch her, her whole body was like on fire, have a horrible headache, her senses are magnified, her sense of smell was overwhelming. Her hearing, she was in tears because just somebody talking to her in a normal voice was like they were screaming at her. Taste, well she cannot taste anything because has not been eating anything on an unspecified date around 23Feb2021 (Reporter was not sure about the date). Reporter stated, "That they don't have. She has been throwing up for a week and she has had vaccine probably 3 days prior to that 2 or 3 days prior to that." Reporter stated, When probed if still experiencing events (event not specified), "Yes it continues to get worse." It was also reported that that patient was in the hospital right now. They believe that she has had a reaction to her Pfizer vaccine, the hospital there doesn't seem to know what to do, they were kind of just given up on her and we don't know who to contact for help. The Clinical outcome of the events was unknown.  Information about batch number has been requested.
Information has been received from a nurse concerning a 61 year old female who on 20-SEP-2007 was vaccinated with Zostavax (Oka/Merck) (Lot #658208/0886U).  On 21-SEP-2007, the patient experienced redness, swelling, and warm to touch at injection site.  The swelling size was 1 inch by 3 inches.  The patient also complained of "knots in stomach" but no vomiting.  The patient sought unspecified medical attention.  On 25-SEP-2007, the patient recovered.  Additional information has been requested.
I immediately started menstruation 5 days earlier than expected less than 1 hour after receiving the 2nd dose of this vaccine. Next I noticed my vision was slightly blurry and I was becoming lethargic. Within 12 hours I had a low grade fever, heart palpitations, and severe night sweats. By 24 hours I felt out of breath if I walked more than 10 feet away and I got extremely dizzy and felt faint if I walked too far. My period lasted 2 days longer than it should have and was heavier than normal. It is now 12 days later and I still feel fatigued, anxious, dizzy, and my hormones feel off. I definitely do not feel right. I get nauseous from the dizziness even though I have been drinking a gallon of water a day and not exercising. I am a very active person and I have been forced to be extremely inactive to keep all of these symptoms at bay.
The shot was administered by a pharmacist. Location/address of administering facility and lot number are unknown to me. I saw the patient 9 days after vaccination and he appears to have a Zoster/shingles outbreak in the same region as the vaccination (left deltoid). I suspect it was the physical trauma of the vaccination that led to activation of the latent zoster infection the same region but I have not previously heard of this occurring with Shingrix.
3 hours after the vaccination,   noticed some tingling and slight swelling of lower lip.  went to ER for evaluation and questions.  Denies any other symptoms.  lasted approximately 3-4 hours.
Headache, Sedation, Myalgia, Fever & Diarrhea Narrative:
Got shot Wednesday at 3:30pm.  Was fine We?d and Thursday.  Arm just sore/hurt.  Thursday went to Dentist (tooth pulled) took 1 -  500mg Motrin for tooth pain. Otherwise body felt fine.   Friday morning I could barely walk.  Got up and had to sit on floor right away for few minutes.  All day felt horrible.  Chills all day. Body felt like it weighed 1000 pounds.  Zero energy.  Hard to concentrate.  Arm turned hard at top and Bright red almost to elbow.  Brownish spots at bottom of red portion of arm.  Took 2 Tylenol to sleep at 7:30pm.  Woke up few times with deep chills.  Slept until 6:30am. Saturday felt much better except arm still bright red and hot where the red is.  Sunday morning arm is still red and super itchy since 4am. Tired (hardly slept since 4am). Got up 6:20am.  Arm still red and very itchy.  Otherwise feel okay.
TDAP given 10/25/10 without incident - no increased pain, redness per client. Sx facial numbness began 11/02/10 to Dr 11/03/10 with dx Bells Palsy & put on Prednisone dose pak - to have MRI if sx persist. 12/14/10 phone call to client reports sx resolved within 2 wks. No lasting effects.
Red raised rash on arm near injection site. With 1st shot it didn?t show up for 10 days and lasted about 5 days. Received 2nd dose yesterday and it was on arm this morning. It?s warm to touch but does not itch. It?s about 3 ? across by 4 ? long.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Sycope episode
Woke up during the night. Felt a little off. Got up to use the restroom. As I finished and got up I started to feel unwell. Like I might vomit. My ears were rushing. Heart rate felt slow. Felt kind of heavy and unsteady when I went to walk. Sat down and had my husband bring me some water. I drank some water and put my head down a bit while sitting up. After a few minutes everything seemed to dissipate and I felt better.
This spontaneous report as received from a health care worker and a medical assistant refers to a patient of unknown and gender. Concurrent conditions and medical history were not reported. The healthcare worker mentioned that on 13-JUL-2015, the patient was vaccinated with an expired dose of MMR II (HSA). The medical assistant reported that Lot number was reported as J010158, expiration date 11-JUL-2015, 0.5 ml subcutaneously (dose was not reported) in preparation for a trip. Concomitant medication was not reported. No adverse symptoms reported. Additional information has been requested.
patient got Shingrix vaccine on 10/23/19  &  she a painful burning rash about 3-4 days after receiving vaccine that resolved in ~1wk. Thereafter,  patient reports she has had an itchy red rash in a band like form on left abdomen that comes and goes, but is relieved when she applies  hydrocortisone to the area.
Patient was exposed to a positive co-worker at place of employment and started with symptoms 3 days later.
PATIENT REPORTED SWOLLEN, RED SPOT ON THE ARM THAT IS WARM TO THE TOUCH THAT SHE NOTICED THE NEXT MORNING AFTER RECEIVING THE VACCINE - AFTER REPORTING TO THE PHARMACY PT TOOK IBUPROFEN TO HELP WITH THE SWELLING
Resident was to begin the Covid vaccination series but was given the Bivalent instead.  He has had no s/e or reactions up to this time
upset stomach; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase increased: 569 (High) 569. On an unknown date, Aspartate aminotransferase increased: 526 (High) 526.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medications were not provided by reporter.
No adverse event reported, other than the wrong dose was given.  (5-11 year dose instead of 6m-4 year).   Completing this form due to RN error.
Had COVID vaccine and was being monitored.  At 10:10am, she became nauseous and started vomiting. She felt short of breath and difficulty breathing. Felt dizzy/lightheaded.  History of anaphylaxis and allergies. History of COPD/asthma. Due to vomiting, short of breath and dizziness, given epipen at 10:15am and called 911.  Continued to monitor and developed worsening shortness of breath. Second epipen given at 10:25am.
Patient developed headache and chills the evening after receiving the vaccine on 5/5/21.  The following day his throat was sore and he had cough and chest tightness.  He took an albuterol  neb which relieved the cough and chest tightness.  I saw him in clinic on 5/7/21.  His COVID PCR was negative.  His lungs were clear.  My assessment is that most likely his symptoms were related to a respiratory virus or seasonal allergies triggering his underlying asthma.  I do not suspect that his symptoms were related to the vaccine.
Patient was administered Kinrix instead of DTaP.   Patient was given only HIB diluent.  No adverse reaction noted.  HIB dose will be repeated.
Tdap given on 7/28/2014. After shot given, was noted on 1 of 3 records that a Tdap had been given on 5/21/14.
Large, red patch a couple inches in diameter around injection site.  Physician diagnosed as cellulitis.  Patient started Bactrim DS 1bid x10d on 12/12/2014.
Patient felt faint and dizziness while in post vaccine waiting area then proceeded to lay herself on the floor before she fell. She also reported nausea at this time. EMT was called and patient refused transport.  EMT reported normal BP and Pulse for the patient.  Patient was able to leave after a short while.
itchiness, very itchy; warm and hot; Hives; Like large hives (they were not small), like a know in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness, very itchy), VACCINATION SITE WARMTH (warm and hot), URTICARIA (Hives) and VACCINATION SITE URTICARIA (Like large hives (they were not small), like a know in the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included TRAZODONE, MELOXICAM, ASPIRIN [ACETYLSALICYLIC ACID], OMEPRAZOLE and METOPROLOL for an unknown indication.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchiness, very itchy), VACCINATION SITE WARMTH (warm and hot), URTICARIA (Hives) and VACCINATION SITE URTICARIA (Like large hives (they were not small), like a know in the injection site). At the time of the report, PRURITUS (itchiness, very itchy), VACCINATION SITE WARMTH (warm and hot), URTICARIA (Hives) and VACCINATION SITE URTICARIA (Like large hives (they were not small), like a know in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported. Patient noticed the itchiness a few days ago. But the previous night, it was particularly itchy, and patient noticed she had like a knot in the injection site, like large hives (which were not small), it was warm and hot.
ADMINISTRATION ERROR : Pt. was administered Influenza High-Dose 10/13/2021 (65+) being 64 at the time of administration.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 14-AUG-2014 the patient was vaccinated with a dose of PROQUAD (Merck) (lot # K008579, expiration date 13-DEC-2015) (dose and route were unknown) which was improperly stored. No adverse effects were reported. Additional information has been requested.
This is a 61 year old male with a PMH/PSH significant for stage 4 prostate cancer diagnosed in 2017 with mets undergoing current chemotherapy (next dose is 12/20/2021) and radiation, recent CT guided left posterior iliac crest bone marrow biopsy and aspiration on 12/3/2021, mediport placement accessed 1 week ago, chronic foley with recent kidney stents, who presented to the ED with increasing shortness of breath. Patient states that he has been experiencing SOB and dyspnea for the past 9 days and decided to come the the ED for worsening symptoms. On arrival to the ED, the patient was found to be hypoxic and his oxygen saturation was 70% on RA other vitals were T-98.7, RR 24 HR 109 BP 87/65. Imaging was done and CXR showed bilateral infiltrates. Lab studies were done and patient was found to be covid positive.