chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received my Moderna COVID-19 booster on 12/27/2021. On the evening of 12/13/2022, I started getting a runny nose. I assumed it was probably caused by allergies. The runny nose continued for the next couple of days. On the evening of 12/15/2022, my tonsils started hurting and I had a slight headache. On the morning of 12/16/2022, I didn't feel any better, so I took a home antigen test. The result was positive. I spoke to a nurse affiliated with my doctor's office. My symptoms were mild, and I had recently lost quite a bit of weight, so she told me that I wasn't really eligible to receive Paxlovid. The tonsil pressure lasted up to 12/15/2022. It seemed to be gone on 12/16/2022, but it returned on 12/17/2022. After 12/17/2022, it never returned. On 12/18/2022, I tested again and got another positive result. The mild headache continued at this time. On about 12/20/2022, my runny nose turned into major sinus congestion that caused me to have some difficulty breathing while I slept; it lasted about 10 days before it finally subsided. I finally tested negative on 12/23/2022. At the time of this writing, I feel fine and have been congestion-free for the last couple of days.
Information has been received from a physician concerning a 3 year old male who in approximately 2002, at the age of one year, was vaccinated with varicella virus vaccine live. The physician reported that two days after taking prednisolone Na phosphate (Orapred), on 08/08/04 the pt developed varicella. It was  noted that the pt had 50 lesions on his body. He was given acyclovir for the varicella. No other information regarding the adverse event was available.There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
crying, inconsolable, fever started 2hr p/vax & lasted 3 days;
The patient was expecting to get the Pfizer Bivalent Covid vaccine, but was given another booster dose of the monovalent instead. This was due to the nearly identical packaging of the mono- and bi-valent vaccine, and lack of double-checking the vial.  No adverse affects occurred.
pt recv vax 2AUG96 & woke up this AM w/raised red rash covering face;
Second shot is greater than day 35; COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot is greater than day 35) and COVID-19 (COVID-19) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L208 and 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine) and Osteoarthritis.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced COVID-19 (COVID-19). On 02-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot is greater than day 35). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN) (oral) on 29-Jun-2021 for Pain, at a dose of UNK mg, prn. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot is greater than day 35) had resolved and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Polymerase chain reaction: positive (Positive) Tested positive for COVID-19.         No concomitant medication was reported. The reporter stated that the patient was given second dose greater than 35 days after the first dose due to patient tested positive for COVID-19 on 10-Feb-2021 and patient did not exhibit adverse reactions due to timing of vaccine dose.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up contains significant information. The medical history added. The lab data information was added. The dose 1 and dose 2 details were added. The treatment medication were added. The event occurred after dose 1 was added.
At 6 am the morning after vaccine I experienced extreme fatigue. Chills. Extreme perspiration. Low grade fever. Vomiting. Nausea. Sore arm
Syncope 10 minutes after Tdap had head injury with this - admitted to ICU.
weak; arm hurt; Every time I move her eyes they follow me; there was brown sharpie lines in both eyes/right eye has halos or brown cobwebs; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), PAIN IN EXTREMITY (arm hurt), VISUAL IMPAIRMENT (Every time I move her eyes they follow me) and EYE COLOUR CHANGE (there was brown sharpie lines in both eyes/right eye has halos or brown cobwebs) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN, ELDERBERRY [SAMBUCUS NIGRA] and MAGNESIUM.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced EYE COLOUR CHANGE (there was brown sharpie lines in both eyes/right eye has halos or brown cobwebs). On 14-Mar-2021, the patient experienced ASTHENIA (weak), PAIN IN EXTREMITY (arm hurt) and VISUAL IMPAIRMENT (Every time I move her eyes they follow me). At the time of the report, ASTHENIA (weak), PAIN IN EXTREMITY (arm hurt), VISUAL IMPAIRMENT (Every time I move her eyes they follow me) and EYE COLOUR CHANGE (there was brown sharpie lines in both eyes/right eye has halos or brown cobwebs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Erythematous maculo popular itchy rash initially started around L arm injection site and spread down to whole L/F upper extremities and trunk. No SOB. (Hep A).
Patient was observed for 15 minutes; complained lips felt swollen had patient take off mask lips appeared normal, Patient was a bit pale and said she might faint. Rushed to her and held her avoiding fall. Patient closed he eyes for 1 to 2 seconds and responded to taps on the chest and calling her name. Opened her eyes, patient had pulse and was coherent.Called 911, police arrived within 10 minutes. In the mean time store management was alerted and BP was taken 157/121. EMS came and patient stated she was better they checked her BP 121/70. Patient refused to go to the hospital. EMS walked her out to her husband waiting in the car.
Felt a little crummy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Five brain surgeries" (unspecified if ongoing), notes: Five brain surgeries; "little pulmonary issue" (unspecified if ongoing), notes: little pulmonary issue. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE:1), for COVID-19 immunization; Bnt162b2 (DOSE: 2), for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt a little crummy". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Likely SIRVA. Chief Complaint:  Pain of the Left Shoulder;  Assessment:  Pain at injection site, initial encounter  (primary encounter diagnosis) Acute pain of left shoulder. Patient denies any injury but states her pain started on Sunday after receiving a COVID shot on Friday.  Patient states she felt the regular muscle soreness after the shot on Saturday but felt pain deep in the shoulder joint on Sunday.  Patient reports that her pain has been worsening since Sunday to the point that she cannot move the shoulder.  Patient states that her pain will worsen with any type of shoulder movement and patient has been taking 800mg every 6 hours since Monday.  When the patient got the shot the patient it was very high on her shoulder.  Is suspected that they may have injected the vaccination into her joint space.  This is caused intractable pain since.  Fortunately patient has suffered from a misplaced injection.     Patient will begin physical therapy for gentle range of motion. I did discuss with the patient that it is imperative that she exercise as much range of motion is possible.  Patient is weight-bearing as tolerated to left upper extremity.  I did provide a prescription of Mobic for this patient to see if this does not help with his skim a lot of anti-inflammatory effect.  The patient and I discussed the safe and judicious use of NSAID medications today.  Patient will follow up with our nonoperative sports medical professionals the next 2-3 weeks for continued clinical correlation.
A consumer report has ben received. The report concerns an 8 year old, consumer of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres, Unknown. FLUMIST QUADRIVALENT started on 28-Dec-2015. The patient experienced high fever, fatigue and running nose. The patient recovered from the event of high fever, fatigue and running nose on an unspecified date. The report was considered to be non-serious.
Initial report received from a consumer, who is also the parent of the patient, on 24 March 2011. A 15 month old male child, with a milk allergy, received on 23 March 2011 a left leg injection (route not reported) of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, sanofi pasteur lot number not provided, an injection (route and site not provided) of PCV 13, Wyeth lot number not provided, and a left leg injection of HIB, GSK lot number not provided. He had no illness at the time of vaccination, no other medical history and took no concomitant medications. The patient received 3 previous doses of PEDIARIX. On 23 March 2011 and immediately after receiving the 3 vaccines, the patient turned blue, went limp, eyes deviated to the right and went to sleep. A few minutes later the patient woke up but was despondent and then became more reactive. The physician diagnosed the event as "pain response" and not a vaccine reaction. The patient had an electrocardiogram performed which was reported as normal. The outcome was reported as recovered. Documents held by sender: None.
Information has been received from a medical assistant who reported that 2 unspecified patients (unknown ages and genders) were vaccinated, on an unknown date, with improperly stored VARIVAX, (lot # M048203, expiry date 07-DEC-2018) for prophylaxis. Information about patients' medical history, concurrent conditions and concomitant medications were not reported. The temperature excursion was reported as -12.8 degrees Celsius (°C) for 30 minutes. It was reported that the VARIVAX was administered after previous excursions as: -14.4°C for 8 hours, -10.6°C for 45 minutes, -13.3°C for 45 minutes, -12.8°C for 30 minutes. The case was reported (called) because of a data logger. No adverse symptoms reported.
28 yo M reported feeling unwell (lightheaded, hot, need to sit down) within 5 minutes of receiving first dose of Pfizer COVID vaccine.  Subsequently had a syncopal event, while sitting reclined between bleacher seats.  His head was supported. Patient was laid down with feet elevated and he  regained consciousness within 15 seconds.  Vitals: 132/79, O2 98%, P 79, RR 16.  No facial edema, rash.  Patient was given water and a snack, was observed for 30 minutes, after which he reported feeling much better.
tested postive; tested postive; Booster; This is a spontaneous report received from a non-contactable reporter from product quality group.  An adult female patient (not pregnant) received bnt162b2 (PFIZER COVID-19 VACCINE), administration date 16Dec2021 (Lot number: unknown) as dose 3 (booster), single, administration date 16Apr2021 (Lot number: EP6955) as dose 2, single, and administration date 26Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. Relevant medical history included Covid-19 (unspecified if ongoing), prior vaccination. The patient's concomitant medications were not reported. The following information was reported IMMUNISATION (medically significant) with onset 16Dec2021, outcome unknown; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome recovering. The event tested positive and tested positive was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures sars-cov-2 test (30Dec2021) positive, post vaccination. Therapeutic measures were taken as a result of vaccination failure, covid-19, and included treatment with OTC meds. Booster 16Dec2021 then exposed 25Dec2021 at family gathering and tested positive 30Dec2021 rapid Ag and sx started 29Dec2021 and 14 family members had been positive.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to vaccination failure cannot be ruled out.
Pt recvd vax adm to clinic on 2MAR92 for generalized hives & edema; also lump (redness) lt leg were DTP was given; also vomiting/diarrhea;
I tested positive for COVID-19 on 11/09/22. I started feeling bad on Tuesday. I had chills, exhausted, sore throat, terrible headache, and body aches. I never had a fever, or nausea. I felt like I had been run over by a Mac truck. I tested positive with a home test and called my doctor. He called in a prescription for PAXLOVID. I took TYLENOL for the headaches. After taking the first dose of PAXLOVID, my sore throat went away immediately. My symptoms lasted for 6 days, and I feel much better now.
Itching and muscle swelling at injection site; still mild swelling on date of report (4/2/12).
Information has been received from a nurse practitioner concerning a child who developed chicken pox following vaccination with varicella virus vaccine live. The patient developed full blown case of chicken pox with more than 30 lesions. The physician saw the patient in the clinic. Another patient was reported with similar episode after vaccination with varicella virus vaccine live (WAES99041532). Additional information has been requested.
HE SAID THE NEXT MORNING HE HAD SHAKING AND CHILLS. THEY CALLED THE AMBULANCE AND ALL THAT THEY COULD FIND WAS AN INCREASED HEART RATE OF 114 BBM. THE SHAKING AND CHILLS HAD STOPPED. HE DID NOT FOLLOW UP WITH ANY OTHER HEALTH CARE PROVIDER.
7:38Flushed initially 7:45Felt upper airway closing associated with SOB and cough 7:52 -58 BP 160/99 O2 sats 98%. Uvula and throat slightly swollen. Was given Benadryl 50mg IM with vitals stable. and then given epinephrine 0.3mg IM. along with 2L O2.  8:03 Patient much better with symptoms clearing
This case was reported by a nurse via sales rep and described the occurrence of redness of legs in a patient who received KINRIX (batch number 7559R, expiry date unknown). On 29th December 2017, the patient received KINRIX. On an unknown date, less than a month after receiving KINRIX, the patient experienced redness of legs and pharmaceutical product complaint. On an unknown date, the outcome of the redness of legs and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the redness of legs and pharmaceutical product complaint to be related to KINRIX. Additional details were provided as follows: Sales rep called to report adverse event for 3 different patients, this was patient 2. The patient experienced baseball size redness on the thigh. This case has been linked to the case US2018005859 and US2018005861 reported by the same reporter.
A physician's assistant reported that a 7 month old male received a 1st dose of Hib-TITER and Infanrix vaccines on 7/12/02, in his left thigh. He also received a 1st dose of Prevnar vaccine in his right thigh on 7/12/02. Following the injection, the child developed a localized reaction of red bumps with papules, 4cm in size, on his left thigh. No further information was available at the time of this report.
About 10 days later, I started breaking out on my left shoulder. The doctor gave me Prednisone, but once it wore off the rash returned. I was then put on another round of it, along with antihistamines. After the second round, the rash went away. The I was advised by my NP not to get the 2nd dose because the rash looks systemic and we didn't know if it was coming from the vaccine or not.
gastroparesis; This spontaneous case was reported by a patient and describes the occurrence of IMPAIRED GASTRIC EMPTYING (gastroparesis) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Gastroesophageal reflux disease and Blood pressure high. Concomitant products included LOSARTAN and AMLODIPINE BESILATE (NORVASC) for Blood pressure high, ESOMEPRAZOLE SODIUM (NEXIUM IV) for GERD, CLOPIDOGREL BISULFATE (PLAVIX), FOLIC ACID and VITAMINS NOS for an unknown indication.   On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMPAIRED GASTRIC EMPTYING (gastroparesis) (seriousness criterion medically significant). At the time of the report, IMPAIRED GASTRIC EMPTYING (gastroparesis) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient visited a doctor and was diagnosed with Gastroparesis and was not able to eat normal food, patient had to puree the food before eating it.  Treatment information was not provided.  Company Comment:  This is a spontaneous case concerning a 77-year-old, female patient with current condition of Gastroesophageal reflux disease treated with esomeprazole, who experienced the unexpected serious (medically significant) event of gastroparesis. The event occurred after the administration of the third dose of mRNA-1273 vaccine, however latency is unknown. Patient described that she was not able to eat normal food and need to puree the food. A doctor has diagnosed with gastroparesis and prescribed a special diet. No further relevant information was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.    Reporter did not allow further contact
The night after meningococcal B vaccine stated w/fever achiness, headache, fatigue. On day #3 developed vomiting. Slowing improving today 8/26/16.
Even with the vaccines, I still have flare ups/Suspected vaccination failure; Still have flare ups (shingles); This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 12-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient reported that even with the vaccines, the patient still had flare ups. The reporter denied to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
This spontaneous report as received from a nurse refers to a 12 year old patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose and route of administration were not reported), lot # L007560. No adverse reaction was reported at the time of the report. This is one of several reports received from the same reporter. Additional information has been requested.
puffiness of all fingers, reynaud's phenomenon, shortness of breath, rash on arms and chest after sun exposure, severe hand pain and sensitivity, severe finger joint pain, changes in appearance to hands, changes in bowel movements, pale/grey stool and pooping less often (this is big because usually I suffer from diarrhea due to my colitis), toe pain in big toes, numbness and tingling in left leg, nausea, changes in eyeslight (multiple floaters in both eyes), slowed healing in hand cuts, overall more achy and fatigued than prior to the injection, occasional red dots on eyelids.
She was extremely fatigued as an high athlete and significant change in athletic performance. She was having heavy bleeding and heavy cramping. She was diagnosed with Crohn?s disease and celiac disease. Hands were always cold.
Headache, Myalgia, Arthralgia, CHILLS Narrative:  Other Relevant History:
paralyzed; This case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a 26-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced paralysis (serious criteria hospitalization and GSK medically significant). The patient was treated with non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the paralysis was recovering/resolving.   The reporter considered the paralysis to be possibly related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the flu shot and less than 24 hours later she was paralyzed from the shot. The patient had to be admitted into the nursing home and have physiotherapy. The patient was recovered but only about 80 percent. The reporter stated reporter would never take a shot for any vaccine.
Narrative: 79 YOM with history significant for CAD/s/p CABG 9/19/14, HTN, HLD, COPD, MG, BPH, psoriasis, GERD, statis dermatitis and lymphedema. Pt had stage IIa LUL SCC and was receiving chemo and radiation. Patient passed away at home on 6/20/2021. He received COVID vaccines in 3/2/2021 and 3/30/2021. Death appears unrelated to vaccines.