chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 30-DEC-2019, the patient was vaccinated with and improperly stored (product storage error), rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (Therapy type: Digital Data Logger), lot number S014948 and expiration date 12-APR-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
arm soreness, radiating pain, fever, chills, decreased mobility lasting 24 hours after injection.
Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizziness, and horrible fatigue. Feeling out of it.
13 y/o female had 30 sec episode of eye rolling and twitching of extremities told by squad "had seizure" (+) fm hx of seizures. Received GARDASIL #3 and FLUZONE 1.5 hours earlier. Also on DURICEF. Seen by ER -> CT brain normal, all labs normal with EEG and neuro consult. Episode may be syncopal rather than seizure.
Localized swelling, warmth and erythema no systemic symptoms; T=cold compresses.
24 hours after booster had flu like symptoms, arm very sore and red for several days. Extremely fatigued. Did not go to doctor.
Did not feel well starting 3rd day after 2nd shot. Waited 2 weeks and went to my doctor.  He ordered blood test and called saying my GFR was 50 so I have kidney failure. He said it often goes away and refused to give me a referral.  I was able to get into U-M  Medical.  After substantial testing they determined I have sarcoidosis and it is poisoning my kidneys.  I am now on Prednisone and blood pressure meds and have a GFR holding at about 48.
Temp 100(R); irritability & screaming. Continued for 4 1/2 hr duration, could not be consoled & refused nursing. Infant normally placcid & content w/little crying. Tx Tylenol, swaddling & eval.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 11-APR-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 670851/0869AA, expiry date 26-JUL-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
By 9:30 pm realized had a voice changes and was hoarse.  By 10:15/10:30 I realized I was having a hard time breathing.  It felt like a strong band was cinched around my chest and pulled real tight. It came in a "spasm"/ "wave" style. Not a familiar experience I have ever had.   In a course of an hour, I found and took puffs about every 15/20 minutes of an inhaler I rarely need (unless playing with my rabbit) and found no relief. It became almost scarry by 11pm to 12pm ish as I feel I lost most of my breath and was very shallow in breathing. I do not have medical as we are currently unemployed, so I just held on and hoped it to get better. Stayed awake through the night. The next day, I felt "weird" in my chest. Best I can describe is a slight tightening with a minor shortness of breath.  Today, 11/23, I feel better.   Called Costco to tell them, they advised seeking advice from my doctor. Well, i don't have one. So I assume getting shots for a previously paid for trip will not be in my future. I will hope for the best. I do have to take Yellow Fever and worry very very much about this. If you can advise as to a safer way to get this done, I would GREATLY appreciate any advice or recommendations :-)
Pt noted ears plugging up and throat closing while driving home, turned around - sx's subsided when she came into clinic HR 86, B/P 140/90, RR 18. Slight anxious talked with state immun. hot line, MD in clinic discharged after watching 1/2 hour. No sx's.
a nurse rpt a pt inadvertently recv 0.1 mL of Td, purogenated intradermally, rather than PPD. next day developed at inject site a 6mmx6mm area of induration, redness & vesicles.
concerning a 19 year old female with diabetes and hypothyroidism on 8/31/06 was vaccainted IM with a first dose of HPV vaccine. Concomitant therapy included an insulin pump, Levothyroxine (Synthroid) and (Loworval). On 10/3/06 (also reported as a month later), the pt experienced hot flushes and cold flashed, nausea, a temp less than 100F and abnormal bleeding. On 11/4/06, the pt experienced right lower quadrant abdominal pain and was hospitalized. She has had a CAT scan, MRI, laparoscopy and a few ultrasounds of the area but all have been neg. The pt was treated wit IV fluids. At the time of this report, the pt had not recovered. No product quality complaint was involved. Right lower quadrant abdominal pain was considered to be an other important medical event (OMIC). Additional information has been requested.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A female patient received BNT162b2 (BNT162B2), on 15Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she got COVID after getting the Pfizer COVID vaccine". Clinical course: Product: Pfizer Comirnaty vaccine booster. The patient and wife on the line. She got COVID even though she was vaccinated with the Pfizer COVID vaccine. Caller stated they could not talk right now because they were at their appointment. Outbound call made at 248pm on 04Jan2022, Caller answered. They are okay with Pfizer following up. There was a product complaint to report. She got COVID even though she was vaccinated with the Pfizer COVID vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient had redness and swelling at injection site. Area was about 4 inches by about 2 1/2 inches. Right arm
Prior to vaccination of booster, patient indicated that she had an "allergic reaction" to first dose Pfizer vaccine where she indicated that she was tachycardic, sweating, flushing, and had raised bumps on tongue.  Patient said that clinic staff had administered 25mg PO benadryl after the reaction, and symptoms completely resolved.   Patient reported no reaction after 2nd dose of Pfizer vaccine.  Today, clinic staff decided to go ahead with Pfizer booster and monitor patient closely.  Baseline vitals at 4:41pm: BP 135/89, HR 96, SpO2 99%.  IM booster of Pfizer administered via IM injection to R arm at 4:44pm.   Vitals at 4:44pm: BP 140/77, HR 106, SpO2 99%.  Patient's fiance noticed raised bumps on patient's tongue at 4:58pm during observation period post-vaccination.  This RN confirmed raised red bumps on back of tongue near pharynx.  Patient felt "warm" but was afebrile (temp 97.9F).   25mg PO liquid benadryl administered.   Vitals at 4:58pm: BP 125/77, HR 88, SpO2 99%.  Vitals at 5:06: BP 137/85, HR 87, SpO2 100%.  Emergency assistance called at 5:08pm after no resolution of bumps on tongue.  EMS arrived at 5:18pm.  EMS transferred patient via stretcher to Medical Center at 5:35pm.
This case was reported by a consumer and described the occurrence of an injection site reaction in a 5 year old female subject who was vaccinated with Pediarix for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. On 5/5/05, the subject received 1st dose of Pediarix in the left thigh. Approximately, one day following the 1st dose of Pediarix, on 5/6/05, the subject experienced an injection site reaction characterized as soreness, a "slight fever" and stated that she could, "barely walk". The subject was treated with paracetamol (Acetaminophen). The outcome of the events was not reported. This case was reported by a physician and described the occurrence of an injection site reaction in a 5-year-old female subject who was vaccinated with diptheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pedirix, GlaxoSmithKline) for prophylaxis. There were no concurrent medications. Approximately, one day following the 1st dose of Pediarix, on 5/6/05, the subject experienced an injection site reaction characterized as soreness, a "slight fever" and stated that she could, "barely walk". The subject was treated with paracetamol (Acetaminophen). The events resolved completely on July 7, 2005. In the physician's opinion, the events were almost certainly related to vaccination with Pediarix.
Patient states that she felt like she was having an allergic reaction. She had hives and felt like her throat was closing. She states that a coworker is a nurse and advised her to take Benadryl. She did so and the reaction subsided approximately an hour later.
About 12 hours after vaccine, had swelling of lymph nodes in the neck, groin, and underam, sore throat, cough and "subjective" fever (no thermometer available with chills); 1/6- reported metallic taste in mouth, then losing the sense of taste.
pt recv vax & devel a rash & inflammation of lymph nodes;pt was dx w/rubella by MD;
28AUG91 pt recvd Engerix-B vax & 10SEP, 14SEP & 17SEP91 pt was Hepatitis Antigen positive; 17SEP91 pt was anti-HBC neg; Reporting MD indicated that Hep antigen, Anti-HBC & total IGM will be repeated in 1-2 wks;
Tremendous swelling in breast and lymph nodes. Fever, chills, nausea, muscle aches.
patient was to receive the Bivalent COVID 12 years and up instead they received the Monovalent COVID 12 years and up in error.
15APR99 noticed rash on face, neck w/some itching;next day had swollen hands/ankles, sore/stiff joints;mainly knees & ankles;Ibuprofen no help;when given vaccine c/o feeling tingling all over body;
This spontaneous report as received from a physician refers to a 5 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 21-AUG-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N000235 with expiration date on 26-OCT-2019 (dose and route of administration were not reported). Since 21-JUN-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
presents  5/8/2021 with red/bloody lesions inside bilateral cheeks, lower lips for the past 5 days or so. Patient denies any new medications.  Patient denies any pain in her body, she noted increased bruising (right hand), and small dots on her skin appear everywhere. She has never had low platelets before. She denies taking any new supplements. She only takes levothyroxine and no other medications at home. She denies taking Aspirin and denies .  admit to inpatient Med Surg, patient with most likely ITP with wet purpura, diffuse petechiae and with platelet of 12K. Patient is currently not actively having any without GI bleed or profuse bleeding. HGB   12.0         Patient  received IV IG infusions on 5/11 and 5/12, as well as continued steroids, and received platelets transfusions ,  Platelets improved to > 50 K by 5/12/2021 , and felt well and ready to go home . On 5/25/21 patient readmitted due to worsening thrombocytopenia during outpatient follow-up.  At last admission, patient had thrombocytopenia with minor oral bleeding and petechial rash, and was sent home on steroid taper. Patient reports tapering down on prednisone as directed, but she began to note increased bruising all over her body, most prominently on her arms. Notes her gums began to ooze again a couple days ago. No hematuria, no melena or dark tarry stools.   will treat with IVIG 1g/kg and rituximab.
Received shot 13 days ago. Still experiencing shoulder muscle pain. Talked to doctor, they suggested Ibuprofen and warm compress. Family physician at facility.
Heart failure; This serious case was reported by a consumer via market research programs and described the occurrence of cardiac failure in a elderly female patient who received Flu unspecified (Flu vaccine unspecified) for prophylaxis.   On an unknown date, the patient received Flu vaccine unspecified. On an unknown date, an unknown time after receiving Flu vaccine unspecified, the patient experienced cardiac failure (Verbatim: Heart failure) (serious criteria GSK medically significant). The outcome of the cardiac failure was not reported.   It was unknown if the reporter considered the cardiac failure to be related to Flu vaccine unspecified.   It was unknown if the company considered the cardiac failure to be related to Flu vaccine unspecified.   Additional Information: GSK receipt date: 18-May-2023  This case was reported via program. The reporter wanted to know why not likely to receive multiple vaccines at the same time. The patient said side effects of getting 2 vaccines could be double of just getting. The patient received flu vaccine 2 years gave me heart failure.
Large red rash-like area with itchiness and feels warm to touch at injection site. Antihistamine taken to combat.
Vaccine administered on 12/29, severe burning while injecting and for 5-10 seconds after injecting. 12/30 noticed lesion on upper arm in area of injection- erythematous, warm, pruritic, raised area, about 4x4cm. No change until 1/5. 1/5: 7.5x4cm lesion, increased pruritus, warm, erythematic, and 3-5 pin-head sized vesicles with clear exudate formed on the medial side of lesion.  Pregnancy history- 4 pregnancies in past 12 months with no live births. 2 miscarriages and 1 ectopic. LMP 12/12/20, patient was pregnant at time of injection but unaware.
Pt had local skin reaction at injection site, headache, and fever. Headache and fever resolved with OTC Tylenol. Skin reaction improved with oral Benadryl. Recommended OTC hydrocortisone cream to apply to site too.
1 day following vax pt devel red, pruritic & painful rash @ the site of vax;tx w/ice & advil & recovered;
Rec'd series of 3 vax given 28MARY90, 28JUN90, 28NOV90; Determined that she was a non-responder; No treatment was given; Outcome: pending; Reporter indicated vaccinee's non-response to the vaccine is permanently disabling;
INCREASED BLOOD PRESSURE; HOT FLASHES; SLEEPING ALL THE TIME; HIVES; CHILLS; FATIGUE/ EXTREMELY TIRED; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included thyroid cancer, previous gallbladder surgery, and tumor removal surgery, and concurrent conditions included high blood pressure, and other pre-existing medical conditions included patient had allergy to steroids and zinc. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim, cetirizine hydrochloride, pethidine hydrochloride, ibuprofen, morphine, and ketorolac tromethamine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: D42A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. Concomitant medications included hydrochlorothiazide, and losartan. On 2021, Laboratory data included: Blood pressure (NR: not provided) 150/90 (unit not reported). On 27-MAY-2021, the subject experienced increased blood pressure. On 27-MAY-2021, the subject experienced hot flashes. On 27-MAY-2021, the subject experienced sleeping all the time. On 27-MAY-2021, the subject experienced hives. On 27-MAY-2021, the subject experienced chills. On 27-MAY-2021, the subject experienced fatigue/ extremely tired. On 27-MAY-2021, the subject experienced headache. On 27-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) Highest temperature 101 and normal temperature 96.7. Treatment medications (dates unspecified) included: hydrocodone bitartrate/paracetamol, acetylsalicylic acid, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and fever on 2021, was recovering from chills, had not recovered from hives, and fatigue/ extremely tired, and the outcome of increased blood pressure, hot flashes and sleeping all the time was not reported. This report was non-serious.
I received a shingles vaccine in my left shoulder in January. For two weeks, I couldn't even sleep on my left side; it hurt so much. It seemed to get better, but now is worse and I would like to restrict my motion, but don't want to lose ability. Doc recommended x-rays, which showed arthritis, which doctor brother says it only means that I had arthritis before the shot. Wasn't aware of it there before. Now I have an appt. with the orthopedic specialist in two weeks.
Information has been received from a physician concerning a female patient in her mid 30's who in September 2007 (exact date not reported), was vaccinated (site and route reported) with the 1st dose of Gardasil vaccine (lot # not reported). Subsequently, after the vaccination the patient developed a headache and dizziness. The interval between administration of Gardasil vaccine and the onset of symptoms was not reported. No laboratory test were performed. The patient did receive unspecified medical attention and recovered. Additional information has been requested.
This spontaneous report as received from a Licensed Practical Nurse refers to a 17 year old female patient. In 2002 the patient was vaccinated with a dose of VARIVAX (Merck), dose, frequency and route were unknown. On an unspecified time, before 2012, the patient experienced shingles. It was unspecified if the patient sought medical attention. At time of report the outcome of shingles was unknown. Additional information has been requested.
This case was reported by a nurse and described the occurrence of fever in a 4 yr old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On an unspecified date in Aug 2005, on or before 11Aug05, the subject received the 5th dose of Infanrix in the right thigh (lot AC14006BA incorrect lot number). On the same day, the subject also received an injection of inactivated poliomyelitis virus vaccine (IPOL) in the right thigh and measles, mumps and rubella virus vaccine (MMR II) in the right arm. On 11Aug05, less than one month after vaccination with Infanrix, the subject experienced fever, and 10cm swelling in the right leg (at the injection site) that was red and warm. The subject was seen in an ER. The events resolved on 15Aug05. The nurse considered the events to be related to vaccination with Infanrix.
Hospitalized 12/2-12/4/21 for bilateral PE. Heme workup  negative for PNG, bet2 glycoprotein, Protein C, Protein S, Factor II, FVL, ACLA, LAC, ATIII, HLA-B-27. Concern for PE provoked from Booster COVID shot (< 3 months).
Muscle and joint pain. I took patient to a doctor in October 2007 who took blood samples to test for rheumatoid arthritis. RA factor was normal, but pain persisted. In 2010 patient was diagnosed with fibromyalgia and is currently receiving medication, but has not had significant relief from her muscle pain. Patient has experience constant and chronic pain ever since shortly after vaccination.
Rash is itchy; Rash is warm; COVID arm rash; Rash is swollen; Rash is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Rash is itchy), VACCINATION SITE WARMTH (Rash is warm), VACCINATION SITE RASH (COVID arm rash), VACCINATION SITE SWELLING (Rash is swollen) and VACCINATION SITE ERYTHEMA (Rash is red) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Rash is itchy), VACCINATION SITE WARMTH (Rash is warm), VACCINATION SITE RASH (COVID arm rash), VACCINATION SITE SWELLING (Rash is swollen) and VACCINATION SITE ERYTHEMA (Rash is red). In April 2021, VACCINATION SITE PRURITUS (Rash is itchy), VACCINATION SITE WARMTH (Rash is warm), VACCINATION SITE RASH (COVID arm rash), VACCINATION SITE SWELLING (Rash is swollen) and VACCINATION SITE ERYTHEMA (Rash is red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 02-Apr-2021, 7 days post vaccination, the patient experienced COVID arm rash and it was reported to be swollen, red, warm and itchy.  No information of treatment was provided. The events were recovered.
4 days after the SPV was administered, the patient noticed another lesions located on his neck. The next day, he also noticed 2 small lesions on the opposite upper arm. He complains of pruritus, however, he denies any fever, chills, myalgias, headache, fatigue, vomiting, nausea, vomiting, shortness of breath, chest pains, visual changes. The lesions at time of exam had progressed to the pustule stage and were at the same stage as the primary vaccination site.
Ping-pong ball sized swelling at site of injection (left deltoid muscle).  Had patient sit, applied ice and gave Diphenhydramine (25mg tablet).  No systemic symptoms reported.  Patient was able to return to work after.
Over 70 warts developed on her arms and legs 11/3/09:  Vaccine record received, VAERS updated.
Post vax, the pt developed 1 1/2 x 1/2 cm redness with approximately 2 cm area of firmness underneath lateral to injection site on right thigh. Prescribed Augmentin for 10 day course.
Information has been received from a physician concerning a 10 year old male who on 07-SEP-2000, 25-AUG-2001 and 12-NOV-2009 was vaccinated with the first, the second and the third dose (lot# 664656/0618Y, rHA) of MMR II respectively. On 12-NOV-2009, the first blood work revealed serum IgM <1:10, serum IgG 0.42 and serum amylase 62. On 20-NOV-2009, the second blood work revealed serum IgM <1:10, serum IgG 5.83 and serum amylase 89. On 30-DEC-2009 the patient experienced mumps (diagnose date reported as 20-NOV-2009). The patient had a history of exposure to mumps. The patient was afebrile. Parotitis count was 131.  It was unspecified if the patient sought medical attention. In follow-up, the physician indicated that on 02-JAN-2010, the patient experienced mumps. On 03-JAN-2010, the patient was diagnosed and was febrile. Parotitis was on the left. No blood work was done. Additional information has been requested.
3x4 red area to left upper arm, warm to touch, no induration, c/o itching, prescribed Benadryl Prn.
OBSTRUCTIVE SLEEP APNEA 3/5/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS