chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O27L2O1) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-006688 (E2B Linked Report).; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product. US-MODERNATX, INC.-MOD-2021-006688:Crosslinked with MOD21-05193 (Husband case)
Administration of vaccine was given incorrectly. It was given too high in the R shoulder.  Pain resulted immediately after administration. Pt can not move her R arm without extreme pain.
Type 1 diabetes; This spontaneous report was received from a male patient of unknown age referring to a himself. The patient's relevant medical history, drug reactions or allergies, and concomitant medications were none. patient stated that no one have diabetes in his family      Onan unknown date in 2006, the patient was vaccinated with measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live(M-M-R II) (lot number, expiration date, dose, dose number, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) for immunization.  The consumer reported that after received measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live(M-M-R II) vaccine, he diagnosed with Type 1 Diabetes in 2012. He states that, he was not diagnosed until 2012 but believes he had it for a couple of years before being diagnosed. The consumer also states that, he received 4 to 5 other vaccines when he received measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live(M-M-R II), possibility the TDAP (he could not recall the names during the call). Patient went to hospital because his blood sugar was 900. The patient stated that he was diagnosed with diabetes and mentioned that, he got it from measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live(M-M-R II) vaccine. . He states that there was scientific proof that the rubella virus can cause diabetes and prescribing information used to state that measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live(M-M-R II) vaccine can cause diabetes. The event treated with insulin and IV drip.  The outcome of type 1 diabetes mellitus was reported as unknown.     The reporter considered type 1 diabetes mellitus to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).  The event was considered to be serious because it led to hospitalization.
Symptoms s/p 2nd dose of Pfizer vaccine. Moderate to severe headache, nausea, body/joint aches and pain, and generalized fatigue resulting in inability to work the day after dose given. Fatigue started around 20:00 on 1/5/2021 (same date as 2nd dose administration), with increasing discomfort throughout the night. Symptoms continued until about 1:00 on 1/7/2021. Peak symptoms 1:00am-12:00pm on 1/6/2021.
Patient presented with redness and warmth at site of injection with no limited range of motion. TYLENOL had been taken. I advised the patient to continue TYLENOL and to take one dose of BENADRYL. She was also advised to seek medical attention if symptoms worsened or did not improve after 2 days. Upon following up with patient, symptoms had resolved.
Patient reported adverse effects on 3/28/2013 at pharmacy, for the first time. Patient had discomfort in arm along with incomplete range of motion. Patient sought attention of 2 specialists, prescription meds & MRI, in addition to an injection, to ease her pain. Adverse event was reported on 3/21/2013 at pharmacy. I do not know when the adverse events started.
Generalized hives day 2 70x90mm swelling around inject site day 20;
Pt recieved a flu shot and called us about an hour later complaining of itchy skin. pt had no injection site reaction or rash/hives she just said her skin felt itchy. Pt also stated this had happened 2 other times in the last 6 months and she is curious if it is food related but she has yet to pinpoint a cause. at this time we are unsure if it is flu shot related. Pt took Benadryl and called back an hour later and itching had subsided.
received children's dose instead of adult dose, patient turned 12 between the 1st and 2nd dose of the series
Bivalent Booster was given instead of monovalent as patients 2nd dose in series.
Information has been received from a lawyer regarding a case in litigation concerning an approximately 18 month old child who on 9/20/96 was vaccinated IM with hep B vaccine recombinant (lot 619858/0531D). An immunization record indicted that the pt was also vaccinated IM with Tetramune (lot 431-966 on 2/28/96); a first and second dose of Tripedia lot 7G8I484 given on 8/14/97, and lot 077I830 given on 4/24/96; one dose of HIB conjugate vaccine lot M3309L and a first and second dose of hep B vaccine lot 1950A2 given on 1/18/96 and lot 1965A2 given on 2/28/96. It was noted that all of these vaccinations contain the mercury laden preservative thimerosal. It is alleged that due to mercury toxicity that resulted from exposure to therefore mentioned vaccines, that on around July 1997, when the pt was approximately 18 months of age, he "suddenly regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior, and the loss of language skills, motor skills and affect." Upon internal review the pt's mercury toxicity, neurological devastation, withdrawn/unresponsive behavior, inability to speak, repetitive behavior and loss of language skills, loss of motor skills and loss of affect were determined to be other important medical events. Further info is expected.
fever to 103.7 p/vax & acute tonsillitis & ant lymphadenopathy;felt fever d/t tonsillitis ? vaccine rxn;
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 70-year-old, elderly patient of an unspecified gender. It was reported that, FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 15-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805478 was crossed linked to original case 201804863 due to same reporter.
Severe ringing in the ears and echoing; Left ear felt clogged; Left ear felt popping; left ear felt clogged and echoing; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 16:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and diabetes. Prior to vaccination, the patient was not diagnosed with COVID-19... The patient took unspecified concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Apr2021 at 16:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient previously received codeine (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. On 23Apr2021 at 16:00, the patient experienced severe ringing in the ears and left ear felt clogged and echoing and popping. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events  severe ringing in the ears, left ear  felt clogged and  echoing and popping   were recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
HIGH BLOOD PRESSURE (Blood pressure high, Hypertension) CHEST TIGHTNESS (Chest tightness, Chest discomfort) DIZZINESS (Dizziness, Dizziness) STAGGERING FROM WALKING (Staggering gait, Gait disturbance) This spontaneous report received from a patient concerned unspecified age female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, copd, thyroid problem, severe arthritis, non-alcoholic user, and non-smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021 patient received covid-19 vaccine yesterday and she experienced high blood pressure (180/120 mmhg), her chest got tight, she was dizzy Laboratory data included: Blood pressure (NR: not provided) 180/120 mmHg. On 13-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 152/106 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high blood pressure, and the outcome of chest tightness, dizziness and staggering from walking was not reported. The reporter provided possible causality assessment. Company causality between JNJ78436735 (Ad26.COV2 .S) and high blood pressure, chest tightness, dizziness and staggering from walking was possible. This report was serious (Other Medically Important Condition).
Pt receive flu and PPV23 on 10/5/2011. She called in on 10-6-11 with report of her left arm with redness and swollen (see attachment) 24 hours post vaccination. On 10/7/2011 she reported that she was diagnosed with staph infection and was prescribed Cephalexin. Blood test was not draw to confirm the infection.
He has given approximately 5 doses out of the first box. Noticed some particles floating in the syringe.; He has given approximately 5 doses out of the first box. Noticed some particles floating in the syringe.; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 28Sep2023, this case now contains all required information to be considered valid.   This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team and a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), LIQUID PRODUCT PHYSICAL ISSUE (non-serious) and all described as "He has given approximately 5 doses out of the first box. Noticed some particles floating in the syringe.". Additional information:White particles floating around in 2nd and 3rd box with one PFS having a 'white blob'. He still noticed the presence of the white particles after shaking the product vigorously. Patient has given approximately  doses out of the first box. Noticed some particles floating in the syringe.After vigorously shaking it has to be homogenous suspension before administration. He went and looked that up in the package insert to check the suspension. After shaking one syringe there was a white blob. He said several syringes had multiple particles. He has opened the other 2 boxes to make observations.   The reporter considered "he has given approximately 5 doses out of the first box. noticed some particles floating in the syringe." not related to pneumococcal 20-val conj vac (dipht crm197 protein). Causality for "he has given approximately 5 doses out of the first box. noticed some particles floating in the syringe." was determined associated to device constituent of pneumococcal 20-val conj vac (dipht crm197 protein) (malfunction).  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300313027 same reporter/product/event, different patient;
swollen painful joints @ lt & rt ankles, rt knee, lt wrist & hand, rt wrist & hand onset 14 days p/vax & cont to 21 days; no hx of liver disease
My arm still hurts; it varies from day to day whether I can even lift it up or not. I haven't gone to the doctor for it.
I recently touched my upper left arm and felt a bump/lump (pea shaped) . Hard, moveable 1/2 inch nodule. Area warm to touch. Not painful when touched.
12 hours after injection, arm swelled, inflammed and hot to touch.  Pt developed fever 103.2 04/26/03.  Swelling and inflammation and fever for 3 days and then symptoms resolved and returned to normal.
Sensation of throat closure; Localized injection site urticarial; hives/generalized urticaria (hives)- limited to face; an hour out with throat swelling had to take a drink to swallow. /her throat started swelling again but worse; Lip swelling; Difficulty breathing; This is a spontaneous report from a contactable other hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER/BIONTECH COVID-19 VACCINE), dose 1 intramuscularly, administered in arm (deltoid) on 02Mar2021 (Lot Number: EN6202) as dose 1, single at the age of 56-year-old for COVID-19 immunization. Medical history included environment allergy. The patient previously took Adrenaline (Epipen) and experienced allergy. No concomitant medications. The patient did not take any medications prior to the event being reported. No relevant test. No laboratory tests or diagnostic studies performed. The patient did not receive any vaccines for any other conditions prior to the event reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to event being reported. The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient experienced hives, an hour out with throat swelling had to take a drink to swallow. /her throat started swelling again but worse, lip swelling, difficulty breathing on 02Mar2021; sensation of throat closure, localized injection site urticarial on an unspecified date. Organ involved included respiratory yes: difficulty breathing (without wheeze or stridor) and sensation of throat closure; Cardiovascular: No; Dermatological/Mucosal: Yes generalized urticaria (hives)- limited to face and localized injection site urticarial; Gastrointestinal: No; Any other symptoms/signs: No. The patient did not require medical intervention. It was unknown if the patient seen in the Emergency Department. The patient was not hospitalized. The patient was not admitted to an Intensive Care Unit. Treatment received for all the events which included benadryl and famotidine. The outcome of lip sweliing was recovered spontaneously on 02Mar2021. The outcome of hives/generalized urticaria (hives)- limited to face was recovered in 2021. The outcome of other events was unknown.
Pt became pregnant while using ocp- TYCYCLEN LO, which she failed to take regularly. Lar p 1/27/2009. Had received GARASIL 12/1/08, 2/20/09 also.
Menstrual cycle disturbances. Extremely swollen, tender breasts, like I have never experienced before. Extreme PMS symptoms. Early period. Unusually heavy period.
78 y/o F with h/o HTN, HLD, prediabetes, presented to ED with pruritus, throat/tongue swelling, hypotension s/p zoster vaccine. Approx. 11am zoster vaccine -> several minutes later - pruritus hands and back, then lightheadedness, chills and blurry vision. Hypotensive to 50s in ED. Then developed tongue swelling and throat constriction. She was given SOLUMEDROL 125mg IV, epi 0.5mg IM x2, and BENADRYL 25mg IV x1, and 3L NS. Tongue swelling quickly resolved following epi injections and SBPs improved to 100s. Symptoms felt to be 2/2 to anaphylactic reaction to vaccine. Patient was monitored overnight in the ICU without recurrence of symptoms and discharged with instructions to immediately return if symptoms recurred.
I had heart palpitations  and headache started at about 11 am. I didn't say anything for about an hour to see if they passed. At noon, I asked to be evaluated. They did an EKG. Normal. Took Ibuprofen and Tylenol . Sent me home to rest for the day. Slept 2:30 pm to 6 am the next day. The symptoms were resolved when I awoke.
Lower Back Pain; Right Leg Extremely Sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm left, administration date 27Feb2021 18:00 (Lot number: EN6203) at the age of 73 years as dose 1, 0.3 ml single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28Feb2021 03:00, outcome "recovered" (02Mar2021), described as "Right Leg Extremely Sore"; BACK PAIN (non-serious) with onset 02Mar2021 08:00, outcome "not recovered", described as "Lower Back Pain". Additional information: The vaccine was administered on the "Left upper arm shoulder". The patient did not receive any other vaccines within 4 weeks and on the same date of vaccination. The patient had no family medical history relevant to AEs or AEs following prior vaccinations. The events did not result in an emergency room or physician office visit.  No follow-up attempts are possible. No further information is expected.
Slight Fever, Severe Aching muscles, especially in your back, arms and legs. Chills and sweats, Headache, Stomach and back pain. Dry, persistent cough, Fatigue, extreme weakness, vomiting.
COVID-19 breakthrough case. Symptoms began: 09/20/2021. Lab confirmed: 09/21/2021.
Information has been received from a Nurse Practitioner concerning a 23 year old female who "approximately 11 day ago" on approximately 26-SEP-2009 was vaccinated with the second dose of GARDASIL (Lot number was not specified). The reporter mentioned that the patient experienced a lump at the injection site and muscle pain in her arm after vaccination. The patient did not seek medical attention. At the time of reporting the patient's outcome was unknown. Follow-up information was received from a certified nurse midwife who stated that a 24 (previously reported as 23) year old female patient with allergy to morphine who on 25-SEP-2009 (previously reported as approximately 26-SEP-2009) received her second dose of GARDASIL (lot # 663453/0249Y). The reporter stated that the patient had swelling in her arm 10 days later on 05-OCT-2009. It was mentioned that patient told to follow up with her family Doctor. The reporter stated that the patient rested her arm. It was also reported that this was patient's second injection in the 3 injection series. The patient recovered from the swollen arm 15 days later on 19-OCT-2009. No further information is available.
I had pain in the bottom part of right rib cage and night sweats for a couple of days. I called my doctor who ordered blood work after I called her about this and about coughing up blood. The results showed D-dimer were very high. She called and told me to go to the emergency room to get a CAT scan. I was admitted to the hospital after the CAT scan on 10/3/22 for Pulmonary Embolism. I was started on Lovenox and then put on Xarelto which I am now taking.
After mild vaccine reaction symptoms (myalgia, chills) I passed out and was unresponsive for 2 minutes.
Within 15 minutes, around my cheek started swelling, confirmed by the nurse. Then around my face started swelling then my lips. About an hour later, my tongue started swelling, but I was already admitted to the ER and was given an IV Benadryl and steroids. I was discharged at 4:30 PM. Around 10 PM started noticing purple-ish rashes on my right arm and left leg.
Fever, headache, myalgias began seven days post vaccination. Today with ? eruption over R shoulders and chest 50+ erythematous papules. No pruritus.
T103 & very irritable started Monday night, saw MD PM w/temp 103.5, is better today;
VERY ACHY LIKE THE FLU, very sore arm, headache (not my migraine type), loose bowels, slight thick feeling in throat, and light fever.99.8.
The day before my daughter had tested positive so I was just anticipating getting COVID-19 myself since we live together. The next day, I started with a fever, and I also had a headache the next day only had a low-grade fever that lasted for three days. I tested positive for COVID-19. I messaged the doctor and the next day she called me and let me know she was calling in Paxlovid. I started taking the medication 2 days later and did a few telehealth appointments. Then I started to feel disorientated let cognitive I had a hard time recognizing some things. I was extremely fatigue and weak. About a week into these symptoms, I developed diarrhea that lasted a week. It was horrible and like water going straight through me.  I was going through so much from the symptoms and the treatment I don't know if I felt better, I was just going through so much for weeks at a time. It was 4-5 weeks to recover..
Information has been received from a consumer concerning her 4 year old daughter with down's syndrome, drug reactions/allergy to KEFLEX and strawberrys and a history of skin tag removal (23-JUN-2008), and "step" pneumonia" (25-JUN-2008) who one month after receiving PREVNAR, was vaccinated on 15-SEP-2008 with PNEUMOVAX (lot # not reported) into left thigh. The mother reported that on an unspecified date, her daughter developed leg and knee soreness in the injection site leg. Lab diagnostics studies performed included "strain", results not reported. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered from leg and knee soreness. No further information was reported. Additional information has been requested.
The nurse hit a vein and so the injection site started bleeding; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (mother).  A female patient (daughter) of an unspecified age (Age:24, Unit: Unknown) received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 03Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse hit a vein and so the injection site started bleeding. The pharmacist on-site explained to them that the bleeding was caused by the vein and that the vaccine has been given intramuscularly so she must have received the dose. The event outcome was unknown.  Information on the Lot/Batch number has been requested.