chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an office manager refers to 2 unspecified patients of unknown age. On unspecified date the patients were vaccinated with dose of PNEUMOVAX 23 (Lot# 672962/0025AE, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. On unknown date the patients experienced unspecified injection site reaction after vaccination with PNEUMOVAX 23. It was not known if the patients sought for medical attention. The statuses of the two patients were unknown. This is one of several reports received from a same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
p/vax pt exp approx six itchy skin lesions @ the inj site described as fluid filled bites;(a little smaller than mosquito bites);
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 001M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with CORTISONE at an unspecified dose and frequency. On 15-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved.            No concomitant medications were reported.   Treatment included Ibuprofen, pain pill, icy hot, hot baths, ice, heating pads
Per patient: got swollen lump on her left neck and under left armpit starting a few hours after the shot until today (4 days).  Pt has been been taken Meloxicam 15mg once daily for her arthritis everyday.  Pt will see PCP tomorrow 7/5 since the pain still persists & more swellings.
fever 100.1 F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 100.1 F) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Splenectomy (she also on biologic and does not have spleen).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PYREXIA (fever 100.1 F). At the time of the report, PYREXIA (fever 100.1 F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
FEELING NAUSEATED, SEVERE STOMACH PAIN/CRAMPS, WATERY DIARRHEA, TURNED BLOODY LATER IN THE MORNING.
Nausea and fever beginning around 3:00 AM the morning following the shot. Dehydration the next day, culminating to an Addisonian Crisis. I had to go to the hospital, where I received fluids and other treatments from Saturday to Wednesday. I developed more nausea and diarrhea in the hospital the last two days I was there, which were attributed to a stomach bug that had been going around in my home.
Bright red and painful rash at site, spreading below site, bright red rash on inner upper arm separated from other rash.
Within a half hour the left side of his face and cheek bone had a weird feeling; His legs and  body have been sore; His  joints have been sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Within a half hour the left side of his face and cheek bone had a weird feeling), PAIN (His legs and  body have been sore) and ARTHRALGIA (His  joints have been sore) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included PREDNISONE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced FEELING ABNORMAL (Within a half hour the left side of his face and cheek bone had a weird feeling), PAIN (His legs and  body have been sore) and ARTHRALGIA (His  joints have been sore). The patient was treated with PREDNISONE for Pain, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. On 25-Jan-2021, FEELING ABNORMAL (Within a half hour the left side of his face and cheek bone had a weird feeling) had resolved. At the time of the report, PAIN (His legs and  body have been sore) and ARTHRALGIA (His  joints have been sore) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pain in arm at injection site. Pain and swelling in armpit on same arm.  Lethargy and slight fever.
Patient was given a Moderna vaccine dose. Patient is only 15 years of age and the dose is approved for 18 and older. The patient has had no adverse events.
CHILLS; JOINT PAIN; SLEEPLESS; ACHES; This spontaneous report received from a patient concerned a male of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up required for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sleepless, aches, chills, and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, aches, joint pain and sleepless was not reported. This report was non-serious. This case, from the same reporter is linked to.
I had vaccination on 03/03/2022. About 2 weeks later I started to experience symptoms of a stroke on 03/22/2022. I had weakness in my left arm and transient memory loss which lasted 3 minutes. On Wednesday evening I had the same symptoms but more intense heaviness on left arm and left leg. I went to bed and woke up with symptoms were much worse. I slipped in the shower due to the left leg weakness. I drove to work and had another episode of weakness in muscles in which I almost fell. A friend drove me to the hospital where I started to stutter. I was sent home with muscle weakness with referral for MRI as I passed the triage for having a stroke. The outpatient MRI showed acute stroke. I was diagnosed with Antiphospholipid syndrome.
redness, induration, warmth in 12x14 cm area on left upper arm.
diagnosed with shingles (on Scalp); 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, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration on 25Jan2021 09:00 in left arm at single dose for covid-19 immunisation. Medical history included CAD (coronary artery disease), allergies: cosmetics, some topical meds, preservatives in eye drops and some perfume. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included atorvastatin (LIPITOR) at 40mg, acetylsalicylic acid (ASPIRIN) at 81mg and fexofenadine hydrochloride (ALLEGRA). The patient historical vaccine included varicella zoster vaccine rge (CHO) (SHINGRIX) and shingles vaccine (unspecified) for shingles, and previously took codeine and experienced allergies: Codeine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Feb2021 22:00, the patient experienced shingles (on scalp). The patient has received both the Shingrix Vaccine and the earlier Shingles Vaccine. So, it doesn't make sense. The seriousness criteria were considered as non-serious. Since the vaccination, the patient has been not tested for COVID-19. Therapeutic measures were taken as a result of diagnosed with shingles (on scalp) included valaciclovir 21 tablets. The outcome of the event shingles was not recovered.
Kinrix administered to a 7 year-old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th January 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 10th January 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 11-JAN-2023 Reporter's comment:  The reporter reported that a 7 years old patient received a Kinrix dose. The reporter consented to follow up. Additional Supportive information: The patient received Kinrix dose at 7 years of age, which led to inappropriate age at vaccine administration.
same day as vaccine, noted quarter-size swelling, redness, and painful.  Increased over the second day, has not necessarily increased today but remains constant. Today measures at 32 mm circumference, irregular, indurated, has papular lesion 10mm.  Has used ice briefly with little effect.  Plans to use ibuprofen and ice, will seek medical care if not improving in 48 hours, sooner if it gets worse.  Advised to seek medical care sooner if she desires. Will follow up in 48 hours with me.
pt brought to ED 9/13/22 with dyspnea; found to be positive for COVID; acute on chronic hypoxic respiratory failure; pneumonia; acute COPD exacerbation; given ABX, breathing tx and steroids; pt's condition improved where she was dc'd on 9/19/22 with home O2 via NC during the day and BiPAP at night; back to hospital on 9/21/22 with poor appetite and generalized weakness, with difficulty getting around; was dc'd to a rehab center; she passed away in the SNF
I reconstituted and administered the dose. When I went to record the administration, the expiration date was not consistent with mfc storage guidelines. We had received the shipment initially, sent to a neighboring pharmacy, and returned to our site. The BUD for our supply we sent to the other pharmacy was expected by unspecified date. The plastic bag from the other pharmacy indicated 12/29/21, thirty days from the date it was sent back. I called the pharmacy it was sent from and was told it came out of the freezer. Unless the supply had been received from another source, this supply had been refroze. I discovered that was the case and reached out to the manufacturer and patient. Pfizer representatives had no data on this type of excursion. I reached out to Dept of Health and was referred to CDC guidance on administration errors and deviations. The clinical decision was made to repeat the dose at the patient's earliest convenience, once we could procure viable vaccine.
After shot, I developed an extremely painful knot and pretty small red splotch. At first I thought nothing of it (12/7/21), 2 days later (12/9)  the knot had gotten noticeably larger. The red spot had now tripled in size? along with more pain and prevention of doing normal things; such as removing a shirt, it was so painful I was sobbing. the next day (12/10) by the time I went to the doctor (today)the knot and red spot had grown even more in size.
a generalized rash that started on her arms and traveled up her body; This spontaneous report was received from a  38 year old female patient, reporting on herself via company representative. The patient's medical history, concurrent conditions and concomitant therapies were not provided.    In approximately July 2019, (reported as "7-10 days ago"), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), 1 dosage form, for prophylaxis (strength, frequency, lot# and expiration date were not provided).  On an unknown date in July 2019, the patient experienced a generalised rash that started on her arms and traveled up her body (rash generalised). The patient did not receive treatment and the rash was resolving.
Patient became unconscious cold, clammy and sweaty. and eyes rolled back. Was unresponsive for about 15 seconds, but had a pulse in the mid 50s. Blood pressure was in the 80s/50s. Nurses from nearby clinic intervened. Patient was placed in the supine position with legs raised up, She slowly became more and more conscious. Responded to verbal commands and became more and more alert.
tested positive for Covid-19; headache; stuffy nose; This is a spontaneous report from a contactable consumer (Patient) and from a Pfizer sponsored program. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EP7534 and expiry date unknown), via an unknown route on 13Mar2021 at 16:30 (at the age of 61-years-old) at single dose on the left upper arm for COVID-19 immunization. Medical history included ongoing Thyroid and Depression. Relevant concomitant medications included Synthyroid (LEVOTHYROXINE) 100 mg daily, Cytomel (LIOTHYRONINE) 5 mg daily on 16Mar2021 for Thyroid and were ongoing. She had been received Cytomel (LIOTHYRONINE) for years and had part of her thyroid removed. The patient also received Wellbutyrin (BUPROPION HYDROCHLORIDE) 150 mg daily on 16Mar2021 for depression. On 17Mar2021, the patient was not feeling well and had a headache and a stuffy nose. On 20Mar2021, with Swab she was diagnosed with Covid-19 positive. Her nose was stuffy and had a really bad headache. On the same date, the patient received treatment with tylenol 325 mg for sinus, headache and phenylephrine 5 mg for nasal decongestion. On 10Apr2021 the patient was scheduled to receive second dose of vaccine. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. The patient was working in a doctor's office that recently closed and she was a receptionist. The patient received treatment with tylenol 325 mg for sinus, headache and phenylephrine 5 mg for nasal decongestion. Outcome of the event stuffy nose was recovered on an unspecified date in 2021 while outcome of the remaining events was unknown.   No follow-up attempts are needed. No further information is expected.
Vaccine was under diluted and patient received dose calculated to be approximately 25% more than recommended.
Tested Positive for COVID 19/Suddenly sick and positive; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and COVID-19 (Tested Positive for COVID 19/Suddenly sick and positive) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     Concurrent medical conditions included Non-smoker (never smoked).    On 23-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Sep-2022, the patient experienced PAIN IN EXTREMITY (Sore arm). On 27-Sep-2022, the patient experienced COVID-19 (Tested Positive for COVID 19/Suddenly sick and positive). On 25-Sep-2022, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, COVID-19 (Tested Positive for COVID 19/Suddenly sick and positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Sep-2022, SARS-CoV-2 test: (Positive) home test came up positive.. On an unknown date, SARS-CoV-2 test: (Negative) PCR test or home test if patient felt a little sick or thought she was exposed, results were always negative.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 23-Sep-2022 Friday, the patient received Moderna bivalent vaccine, and she had the usual side effects during Saturday into Sunday of fever, headache, fatigue, and sore arm which passed by Sunday afternoon. On 26-Sep-2022 Monday, she started sneezing and blowing her nose. On 27-Sep-2022 Tuesday, she felt like she was getting a cold. So, did a home test and it came up positive. She further stated that, she and her husband both still wear masks in every store they enter and only time not masked was an occasional dinner out and with their senior bowling league if none had signs of illness. She wore masks all last winter season bowling and not entering any restaurants and only take out once in a while. She never got COVID that whole time. She would either get a polymerase chain reaction (PCR) test or home test if she felt a little sick or thought she was exposed, and results were always negative. She had not lost her taste or smell. Her symptoms were runny nose, scratchy dry cough, similar to a cold with no fever. She was a retired nurse and was very careful with wiping the handles of shopping carts and hand washing frequently and mask wearing. She was aware that there was not supposed to be any live virus in a vaccine but did not understand why she was suddenly sick and positive.   She stated that, she was relatively healthy, never smoker or diabetic.   No treatment medications were reported.
Could be a bacteria related or cellulitis; Had a rash at the injection site that has continued to get worse; Redness at injection site; Itchy; Warm / hot; Hard; Got larger size of baseball; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Could be a bacteria related or cellulitis), PRURITUS (Itchy), SKIN WARM (Warm / hot), INDURATION (Hard) and SWELLING (Got larger size of baseball) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (Could be a bacteria related or cellulitis) and VACCINATION SITE RASH (Had a rash at the injection site that has continued to get worse). In January 2021, the patient experienced PRURITUS (Itchy), SKIN WARM (Warm / hot), INDURATION (Hard), SWELLING (Got larger size of baseball) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE CELLULITIS (Could be a bacteria related or cellulitis), PRURITUS (Itchy), SKIN WARM (Warm / hot), INDURATION (Hard), SWELLING (Got larger size of baseball), VACCINATION SITE RASH (Had a rash at the injection site that has continued to get worse) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 08-AUG-2015, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot # L006545 expiration date -23-OCT-2016. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Felt fine for first few days, then very fatigued for 2 days, then mild headaches for 4 days, then terrible headache for 2 days, then mild headaches for about next 4 days.
SIRVA Left shoulder large bulge posterior area. Bursa swollen. Spongy on pressure, like a large ball. Initially size of baseball. Has reduced slightly in size. Still prominent. Still visibly present.
After the patient received his vaccine, he said it was like he had went to the dentist, the left side of his face was numb. The next day his eye was giving him trouble. On the third day his mouth was not working. They bandaged the eye up to keep it moist.
This was my second Moderna booster shot.  On 7/13/2022 I tested positive for Covid.  I am scheduled for monoclonal antibody therapy, we will see what the outcome is.  This is a breakthrough covid infection.
resident received 1st dose of Moderna at hospital on 2/21/21. Patient admitted to nursing home on 2/22/21, the day of our first clinic- transition of care did not identify covid vaccine having been given from day before. our state did not have the hospital dose entered when we entered our 1st dose. Patient received 2nd Moderna dose. on 3/24/21 from our clinic  which at that time of documenting in our state of the 2nd dose did we see it actually was her 3rd dose.
Improper storage of product in use; This spontaneous report was received from a licensed nurse practitioner concerning a patient of unknown gender and age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 28-JAN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T024281, dose:0 .5 milliliter, expiration date: 15-JUL-2022, dose number and route unspecified)  for prophylaxis. The administered dose of the vaccine experienced a temperature excursion 7.1 degrees Fahrenheit for 50 hours/ 45minutes. It was reported that the vaccine was no exposed a previous excursion and it was not recorded by data logger. No product quality complaint was involved.
Swelling red itchy injection site, fever, back pain, nausea/vomiting, headache
ErythemaMultiform & tenderness at injection site, progressive sensation "moved down my arm", On 7/31/19 pt returned to clinic with marked swelling, tenderness, & redness
Patient showed syncope, body wide muscle contraction, patient became stiff and would have fallen to the floor if not already in a chair. Event lasted around 30 seconds
First 24 hour I was mildly tired, achy and weak. Throughout the day following my shot side effects got worse. At the 26 hour mark I had a fever of 102.2 and won?t break. Very achy and weak.
1 day p/vax pt devel diarrhea & fever, rash to legs 3 days p/vax;worsened on 21FEB99;seen @ clinic 21FEB99 & etiology of rash pt placed on med;seen @ clinic 22FEB99 believes has erythema multiforme poss r/t vax;
pt recvd vax 25OCT94 & 27OCT had t102 ax, lips quivered, eyes rolled back in head & went body limp, lips blue called 911; unconscious x several mins; taken to ER; cxr neg; Atropine aerosol given, pulse oximeter 97%, rx Amox 125/5 tid;