chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 23 year old female with Crohn's disease who on 18-FEB-2008 was vaccinated with a first dose of GARDASIL (lot # not reported).  On approximately 20-FEB-2008, "within days of receiving the first dose of GARDASIL", the patient experienced severe joint pain, myalgia, and fever.  It was reported that "the joint pain and myalgia caused the patient to experience difficulty walking for a period of approximately two weeks.  Subsequently, the patient recovered from the severe joint pain, myalgia, fever and difficulty walking.  The patient sought unspecified medical attention in an office visit.  Additional information has been requested. 02/18/2010 On an unspecified date, the patient recovered from myalgia and fever. It was later reported that on 20-FEB-2008, the patient complained of joint pain affecting all joints, including ribs, espcially upon "inspiration". The patient experienced difficulty going from sit to stand and could not stand for extended periods, had numbness/tingling in fingers and toes, pain in scalp, and extreme tiredness. The duration of the joint pain affecting all joints, including ribs especially upon "inspiration", difficulty going from sit to stand, inability to stand for extended periods, numbness/tingling in fingers and toes, pain in scalp, and extreme tiredness was five days. The patient sought unspecified medical attention in an office visit twice. The patient outcome was recovered.  Additional information has been requested.
Diarrhea; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included Knee surgery NOS in March 2021. Previously administered products included for Knee surgery NOS: Diclofenac (Took diclofenac after knee surgery in March.) in March 2021. Past adverse reactions to the above products included No adverse event with Diclofenac. Concomitant products included ATORVASTATIN and CARVEDILOL for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea). On 15-Apr-2021, DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided.   This case was linked to MOD-2021-406564 (Patient Link).
Severe headache starting 1 hr after shot, followed by cough / chest tightness, achy joints, fever lasting about 20 hrs. Pt has recovered.
PT STATES ARM PIT SWELLING AND TENDER 1 DAY AFTER SHOT. RESOLVED COMPLETELY BY DAY 7.
Patient given 0.2 mL of Adult formulation Pfizer COVID19 vaccine. Correct dosage, incorrect formulation for age of patient. Mother of patient informed, no adverse reaction reported.
About a month after receiving my second dose, I started to experience numbness on my forehead. I thought it was something to do with my MS. My eye started to became inflamed and I could barely open it. I did a tele-health appointment with my doctor who told me to go to the ER. They told me that I had shingles. I was given a prescription for Valacyclovir and Tylenol. It cleared up after about two weeks. I did have to see an ophthalmologist to make sure there wasn't an infection in my eye.
Fever, rash, pharyngitis, otitis media, exanthem on soft palate, maculo papular rash on face, trunk & extremities. Few petechia sub mandibular lymphadenopathy, liver 2 cm down, spleen tip 1 cm down, injected conjunctivitis, cough
Headache, 99 - 102 fever, queasy stomach, aches in bones, fatigue and sleepy.
The right thigh of the baby showed a lot of redness and the left thigh turned a shade of purple and also displayed some redness.  The arms also showed redness and turned a shade of purple.
Mother stated "gave breathing medicine to my baby at 5 PM Friday and baby began to choke and cough. Took baby to the ER and she died at midnight."  9/25/07 Reviewed medical records provided by reporter which reveal patient in good health on day of vax.   Admitted to ER on 3/22/07 w/difficulty breathing & vomiting.  Family noted hospitalization x 5-6 days for RSV bronchiolitis & d/c 3 days prior to ER visit. Tx w/nebs & supplemental O2 w/initial improvement but then worsened again.  Mottled cool skin w/sluggish cap refill, tachycardic, prolonged expiratory phase respiration, tracheal tugging, intercostal & subcostal retractions, fever 105.  Multiple attempts to establish IV access & to obtain ABG were unsuccessful.  Intubated emergently.  Had to start chest compressions secondary to EMD.  Epi administered via interosseos access as well as endotracheal w/o initiation of  perfusing rhythm or spontaneous breathing.  Reporter notes indicate patient expired w/dx respiratory arrest secondary to RUL pneumonia. 12/4/07 Received autopsy report which states COD as acute bronchopneumonia due to viral respiratory infection.  Manner of death: natural.  Findings at autopsy: chronic inflammation, upper & lower airways; acute & chronic otitis media; and acute bronchopneumonia.  Had been seen hospitalized 3/15-3/19/2007 w/RSV pneumonia.  Worsened 3/22/07 & taken back to ER where she arrested.
Patient called 08/23 advising pharmacy manager that she had immediate (08/04/2020) radiation of pain from injection site to neck, pain was irritating the first day, and minimized to dull irritation but has continued every day until 08/23 and continues. She has been alleviating pain with Advil PM and Advil but it is not ceasing pain.
at 10:26 Seeing Stars, decreased hearing. Felt like he was "going to pass out."  History near syncope during shots (vaccines) . At 10:24 VS: HR:30 BP: 65/34   O2: 100% at 10:34 States he's "feeling a lot better." at 10:34 States he's "feeling a lot better."VS:  HR:74 BP: 132/109   O2: 98%. See n by EMS on site. Discharged home, leaving at site parking lot.
Pt calls to say she received a PNEUMOVAX injection on 8-15-17 in her left arm She is now complaining of her arm being swollen and red down to her wrist. It is also painful, 8/10, she took her Tramadol which helped the pain. She has been using ice. Denies that it feels warm.
A pharmacist relayed information from a physician concerning a pt who received vax live. Subsequently, within the same month the pt experienced measles. The reporter expressed concern with the vax lot. No further information is available.
Pt rec'd flu vaccine IM (L) UE. Red itchy w/i 10". Within 30" redness enlarged "mouth itchy"
This spontaneous report as received from a nurse via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, dose, route, indication not reported). Concomitant therapy was not reported. On an unspecified date the patient's left arm became swollen from the shoulder to the elbow after receiving PNEUMOVAX 23. Outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
On 12/01/2021 08:00am I started feeling congested and coughing. A day or so later I had a sore throat and congestion that went away. The coughing is still persistent.
Circular area ~3 inches diameter, light pink with darker pink edge, slightly swollen & painful
On 2/15/2022, I was admitted to the Medical Center to undergo surgery to remove my right kidney and ureter, as I had cancer in those organs. I was released from the hospital on 2/16/2022. On 2/17/2022, I began experiencing COVID-19 symptoms, so I took a home test, which yielded a positive result. I experienced cough, chills, rigors, and shortness of breath. Over a period of a few days, my wife, my son, my daughter, and my wife's girlfriend also tested positive for COVID-19. However, their symptoms weren't as severe as mine. I speculate that the severity of my symptoms may have been due to the fact that I was recovering from surgery. This was a breakthrough case.
FACIAL FLUSHING, REDNESS AT INJECTION SITE Pt. IMPROVED AND WAS RELEASED FROM SCENE. Pt. STATED SHE WAS GOING HOME HUSBAND WAS DRIVING DR. TOLD Pt. IF CONDITION REOCCURED SHE COULD TAKE ANOTHER 25mg OF BENADRYL, IF CONDITION WORSENED OR DIFFICULTY BREATHING TO CALL 911. 25mg BENADRYL AND 40 mg OF FAMOTIDINE GIVEN PER DR. Pt. CONDITION IMPROVED WHILE BEING OBSERVED. VITALS MONITORED ALL WITHIN NORMAL RANGES AND Pt. STATES NO DIFFICULTY BREATHING, LUNG SOUNDS WERE CLEAR. 15:47 BP 130/80 PULSE 74 SPO2 97. 15:59 BP 126/80 PULSE 70 SPO2 97.
side effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effect). At the time of the report, VACCINATION COMPLICATION (side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Shingrix 4- 4 and ½ years ago, breakout a month ago/suspected vaccination failure; Shingles twice a year; Received Shingrix about 4- 4 and ½ years ago; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had first case of shingles about 10 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, unknown arm) .5 ml and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Shingrix 4- 4 and ½ years ago, breakout a month ago/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles twice a year) and inappropriate age at vaccine administration (Verbatim: Received Shingrix about 4- 4 and ½ years ago). The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). The outcome of the vaccination failure and inappropriate age at vaccine administration were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 15-Mar-2023 The patient reported that she received both the doses of Shingrix vaccine about 4 to 4.5 years ago and experienced a breakout of shingles on her backside every 6 weeks.   The shingles would clear-up after 3 weeks with antiviral medications in most cases.   Since receiving the Shingrix vaccine, 4 years ago, the patient reported she now had the breakout on her backside about twice a year. It was a much lesser breakout, it did not need antivirals and it usually clears up in 4 days.  The last breakout was about a month ago. The patient did not share her health care professional information since she had a new health care professional that had not seen her yet. The reporter did not consent to follow-up. The patient received the Shingrix vaccination at inappropriate age, which led to inappropriate age at vaccine administration. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
I was on a trip and one of the other people had COVID-19 and I ended up with it. I'm thinking it was from the other person but I'm not sure. It felt like I was having acid reflux with my throat burning like it was on fire.  I had a fever and sore throat with mild coughing. I saw my doctor and she prescribed me Paxlovid.
Amyloidosis; felt a sweep over her stomach up her body and up to her head; Eyes swollen; hands hurt; sharp pings up and down legs; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on the left arm on 16Jan2021 13:45 at a single dose for COVID-19 immunization. Medical history included ongoing diabetic and previously took the flu shot one time and started having right arm pain across her chest over to the left side right after getting it. So she don't take it anymore and takes a bunch of herbs. The patient's concomitant medications were not reported. The patient reported that she has a disease, amyloidosis on an unspecified date, where there is a build up of protein in the body. She didn't know that there is protein in the shot and doesn't know the affects it has with her condition. She found out the day after getting the first Pfizer C-19 (clarified as COVID-19) shot that there was protein in it. The patient wanted to know the affects it has with her condition and if it will affect her getting the second dose and if it covers the new virus and booster shot. The patient got the vaccine on 16Jan2021 and found out about the protein in it the next day when it came across her phone. The patient received it at a school, where they vaccinated 1,169 residents. They text her to inform her she could get the vaccine. They also have the health department there. No other vaccines given that day or 4 weeks prior. On an unspecified date in Jan2021, the patient took 1 Tylenol about 15:00 that afternoon and seated herself in the chair about 17:45, then she felt a sweep over her stomach up her body and up to her head. She stood up and walked around to see if she was going to faint and she did not faint. She walked through the house and nothing else happened. The patient mentioned that her eyes have been swollen and her hands hurt, that's where the protein build up comes in the body. Has pings up and down her legs, they are sharp pings that lasted through on to Tuesday. She took 1 Advil to help and as of yesterday (as reported) no pings. Her hands still hurt, because this condition forms chains in the body and the chains are around the hands like carpel tunnel. The protein normally should leave the body and with this condition it doesn't and it leaves chains. When she was diagnosed with it they took a spot off the ankle to test it, the Dermatologist did and sent it off. No further details provided. Wants to know the affects of her getting the second shot. No further details provided. The outcome of the events amyloidosis and hands hurt was not recovered, the events felt a sweep over her stomach up her body and up to her head and sharp pings up and down legs was recovering, and the event  eyes swollen was unknown.
Case number PHEH2015US004135 is an initial spontaneous report received from medical assistant on 27 Feb 2015: This case refers to an 11 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch numbers: U5036CA, U501BAA, U5018AA, UI173AB, IU173AB, UI207AB, UI2O7AB, 14511F) at a dose of 0.5 ml intramuscularly on 26 Feb 2015, which reached 31 degree Fahrenheit for two hours. No adverse event was reported following this administration error.
Information has been received from the mother of a female infant with no known allergies who was vaccinated with a dose of hepatitis B virus vaccine. There was no concomitant medication reports. Subsequently the patient developed a seizure. The outcome of the patient's seizure was unknown. Upon internal review, it has been determined that the patient's seizure was considered an other important medical event (OMIC). Additional information has been requested. The mother also reported that the patient, at the age of 13 months, developed insomnia and involuntary movements of the arms and torso while on therapy with famotidine.
Moderna COVID-19 vaccine second dose is to be administered at 28 days after the first. Patient second dose was given 7 days early.
Case number PHEH2013US016332, is an initial spontaneous report received from a medical assistant on 30 Jul 2013. This report refers to 11 year 3 months old male child. He was vaccinated with MENVEO (batch number: unknown) at a dose of 0.5 ml intramuscularly on 17 Jul 2013. On 18 Jul 2013, he experienced localized red reaction at injection site. Outcome, seriousness and causality assessment of the event was not reported.
Urticarial rash all extremities with few on face and upper chest, sleeping a lot. Last 3 days Zyrtec liquid 1/2 tsp. 1-2 x day, did not give. Rash disappear after 3 days.
FACE RED, RASH ON ARMS, LIP SWOLLEN, WENT TO DOCTORS CARE AT FOUR, I WAS AT WORK AND COULDN'T LEAVE UNTIL FOUR. HAD MILD EFFECT BECAUSE I WAS ON METHYLPREDNISONLONE FOR SHINGLES.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DM" (unspecified if ongoing), notes: DM; "HTN" (unspecified if ongoing), notes: HTN; "h/o breast cancer" (unspecified if ongoing), notes: h/o Breast cancer. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical closure: Anti-viral details: Paxlovid from 18May2022 to 22may2022, oral route for Treatment of COVID-19. Adverse event: Relapse in covid-19 symptoms 48 hours after completion of Paxlovid treatment for covid-19 infection.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
03/05/03 Developed red lesions more on trunk and upper arms; less on lower legs. One lesion right buccal mucosa. Few with early vesicles.
AT 1605 PALE,  DIAPHORETIC,  NAUSEA TREATMENT- AMMONIA, ICE PACK,  OUTCOME- WENT HOME WITH WIFE WITHOUT ANY ISSUES
Reaction on left upper Deltoid area. Swollen and slight itching, redness hot to touch. Denies pain or any limitation to move arm.
Syncope after event while standing at check-out desk.  3 weeks later, had an episode at home concerning for first time seizure that necessitated ER visit and further workup (ongoing).
Patient was given the first dose of Moderna vaccine. After administration, patient experienced flushing around the neck. Patient was given Benadryl and asked to wait around for 15 minutes for monitoring. Patient stated he felt fine afterwards and the redness around his neck has subsided. Patient left the pharmacy after the 15 minute wait.
As soon as I got it, I got extreamly dizzy and has been dizzy every since. I am having heart issues with you blood pressure and my heart rate, both will go very high and then bottom out. I am having neurological issues with my memory, and like performing daily tasks is hard. My lungs, I suddenly have severe copd, since getting the vaccine. Nausea that wont seem to go away with extreme dizziness.   Er visits were at Medical Center ranges from March 2021 - present.  I had 2nd Moderna shot on  April 9, 2021   Lot # 030B21A
whole body achiness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (whole body achiness) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No medical history was reported.     On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (whole body achiness) and FATIGUE (fatigue). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, PAIN (whole body achiness) and FATIGUE (fatigue) outcome was unknown.            Reporter did not allow further contact
Experienced shakiness immediately after vaccine and 5 days after has 'bumpy' rash on arms (R) leg and abdomen and back. Mom reports she had bruising on (R) leg at immunization site. Had no rash on (L) leg per mom. Reaction/sxs not witnessed by provider.
As stated by biological mother, child developed hives and had difficulty breathing. Child is known asthmatic and was advised to go to emergency room. At hospital, child received three injections Benadryl and went home.
Discharge Provider: Private Primary Care Provider: FNP Admission Date: 2/27/2023 Discharge Date: Mar 2, 2023  PRESENTING PROBLEM: Respiratory insufficiency [R06.89] Generalized weakness [R53.1] COVID-19 [U07.1]   HOSPITAL COURSE: 79 y.o. male with past medical history significant for AAA s/p repair, essential hypertension, hyperlipidemia, prostate cancer, Parkinson's disease who presents the emergency department 3/27 for generalized weakness. Patient had cataract surgery on Friday and then the following day developed worsening weakness. Found to be positive for COVID-19 virus. In the emergency department the patient severely hypertensive with BP as high as 216/82. Patient mildly hypoxic with SPO2 down to 88% and placed on 2 L nasal cannula with good saturation. CXR with poor inspiration but no convincing active lung disease. D-dimer elevated, and thus CTA chest obtained which revealed no PE, mild atelectasis of the lung bases, prior granulomatous disease. Patient admitted for respiratory insufficiency secondary to COVID infection. Patient was treated with remdesivir and dexamethasone with improvement in symptoms, weaned off oxygen to room air. PT/OT evaluated patient and recommended home with assist. Of note, patient with persistent hypertension on home regimen and was started on HCTZ for improved BP control. Patient medically stable for discharge home 3/2.   Wife called and updated on care plan. All questions and concerns addressed. Of note, wife also with COVID infection, though feels well overall.
On 10/6/21, patient developed acute chest pain and dyspnea. She was found to have  a sub-massive pulmonary embolism (present in bilateral pulmonary arteries with extensive extension into all 5 lobes) causing significant right ventricular strain and subsequent decreased right ventricular systolic function.
Slightly sore arm General malaise feeling Sore, achy muscles Headache Chills Lethargic, lack of energy Tired Hard to concentrate; want to lie down and close my eyes
Onset morning following. Myalgias, severe HA, mild nausea, arthralgia, temp to 105, chills. No GI sx, no new rash. (L) upper arm: hot, red, very swollen, limited ROM, tender to touch.
Big 4 inches long 3 inches wide red hot spot on same arm where it was given. Headache. Short of breath, pain on left side of chest. Weak, tired. Muscle hurts.