chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose 15Nov2019, has not received second dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th November 2019, batch number SKBMBP52).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: This case was reported by the pharmacy technician. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter was not sure about the batch number, no expiration date. The reporter consented to follow up via email.
Ten Day Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Ten Day Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Ten Day Headache). At the time of the report, HEADACHE (Ten Day Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided.
Pain, redness and swelling in Lt upper arm below injection site. Throat tightness Hives below injection site
anxiety; depression; insomnia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 26Mar2021 08:30 (Lot number: EN6204) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; HYDROCHLOROTHIAZIDE; ROSUVASTIN; KRILL OIL. Past drug history included: Morphine, reaction(s): "known allergies: Morphine", notes: known allergies: Morphine, Prevnar13. Vaccination history included: Bnt162b2 (Dose 1, lot number (EN6202), administration time was 08:00 AM), administration date: 03Mar2021, when the patient was 68 years old, for Covid-19 immunisation; Prevnar13 (known allergies: Morphine, Prevnar13), reaction(s): "known allergies: Prevnar13".  The following information was reported: ANXIETY (non-serious) with onset 01Apr2021, outcome "not recovered", described as "anxiety"; DEPRESSION (non-serious) with onset 01Apr2021, outcome "not recovered", described as "depression"; INSOMNIA (non-serious) with onset 01Apr2021, outcome "not recovered", described as "insomnia". The events "anxiety", "depression" and "insomnia" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of anxiety, depression, insomnia.  Additional information included: About 3 days after the 2nd dose, insomnia started. Nothing helped. It was still ongoing, and anxiety and depression were bad. Trazodone had given some relief, but not entirely reliable. Patient's need help. No other vaccine in four weeks. Other medications in two weeks were Losartan; Hydrochlorothiazide; Rosuvastin; Krill O. No Covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Nausea after the 2nd dose; Blossoming headache after the 2nd dose; 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 NAUSEA (Nausea after the 2nd dose) and HEADACHE (Blossoming headache after the 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   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 NAUSEA (Nausea after the 2nd dose) and HEADACHE (Blossoming headache after the 2nd dose). At the time of the report, NAUSEA (Nausea after the 2nd dose) and HEADACHE (Blossoming headache after the 2nd dose) outcome was unknown.            No concomitant medications were reported No treatment drugs were reported
This spontaneous report was received from a healthcare worker (quality assurance coordinator) regarding a 34 year old patient(gender unknown). The healthcare worker reported that her facility had administered 9 doses of RECOMBIVAX HB, lot # J001183. On 07-MAY-2013, the one of the patient's was vaccinated with dose 1 of RECOMBIVAX HB (lot # J001183, expiry: 08-SEP-2014). At the time of this report(01-JUL-2013), the patient had not yet received dose 2 of RECOMBIVAX HB. No adverse effects reported. This is 1 of 6 reports received from the same reporter. Additional information has been requested.
Edema of right thigh to knee. Painful - limping - acute started evening of day received vaccine. Treatment - BENADRYL, ORAPRED & warm compresses.
Child had patch or "cluster" of hives on back right side between shoulder blade (2-3" wide) and armpit down to waist. Mom states she "saturated" area with hydrocortisone cream and gave Benadryl at 1p.m. Had given tylenol at 12:00.  Recommend seeing PMD this A.M. - states she will see doctor.
Vaccinated March 17, 2021.  In July I started noticing allergic reactio on hands. (Itching).  In August I was stung by a honey bee and had allergic reaction.  Had to take epinephrine.  Never before in 68 years have I ever had any allergies.   Don't know if related to vaccine or not.  Just thought it was notable.
only received one vial of the Menveo two-vial presentation; only received one vial of the Menveo two-vial presentation; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: only received one vial of the Menveo two-vial presentation) and inappropriate dose of vaccine administered (Verbatim: only received one vial of the Menveo two-vial presentation). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 25-APR-2023 The reporter was medical assistant. The reporter reported that the patient only received one vial of the Menveo two-vial presentation.  The chat was disconnected before consent was asked. The patient only received one vial of the Menveo two-vial presentation, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Seven hours post vaccine: severe pain in both hands, strong headache, nausea, strong body aches, chills, elevated heart rate, temperature 1 to 1.4 degrees above my normal. During the night, several episodes of copious sweating. On 10/01/2021, hand pain was quite reduced, nausea was gone. On 10/02/2021, hand pain, headache, body aches resolved. But chills, sweats, and elevated heart rate continued. By 3 p.m. on 10/02/2021, deep pain in Right lower leg. Heart rate normalized sometime overnight. On 10/03/2021, still experiencing Right lower leg pain and throbbing. And still having chills and sweats during the night.
HEPATITIS B IMMUNIZATION. AROUSED WITH RT ARM SWOLLEN, WARM, FIRM, SORE. ICE PACK PLACE TO ARM.
I have been experiencing some tingling on the left side of my face since receiving the first COVID-19 vaccination dose. It flare after receiving the second COVID-19 vaccination dose. The level of tingling varies throughout the day. It has not resulted in noticeable paralysis.
Myalgia, Fever, Sore arm; ringing in ear Narrative:  Day Two: Soreness around injection site, body aches, low grade fever, fatigue Day three: Soreness around injection site, Body aches, fatigue Day four: Fatigue Day five: Periodic ringing in right ear
Staff member received Pfizer bivalent vaccine but did not have the primary series. No adverse reactions noted
RASH ON FACE,TRUNK, EXTREMITIES >50 LESIONS  DX: VARICELLA.
One week after the injection, my upper left arm turned red with what looked like a rash and itched.  The injection site turned very red.  It was totally gone the next day.
RASH LIKE ON WAIST BOTH SIDES, WENT TO DERMATOLOGIST ON 11/18/2009 RECVD CREAM THEN OVER THE COURSE OF WEEK SPREAD TO ARMS THEN LEGS THIGHS  AND CALFS WENT BACK RECVD ANTIHIS 12/3/2009 RECVD ANTIHIS THEN MOVE TO MY BACK.
Fever up to 102.6, body aches, extreme fatigue, coughing up blood (bright red), chest tightness, general malaise -Feels like the flu
The night after receiving the vaccine, I developed fever, severe muscle aches, nausea, headache, and a red area on my arm.  These symptoms progressively got worse through the next day.  Fever got up to 102.  On 12/20/2020, I felt some better with temp 100.2 headache and body aches.  Today is better with temp just 99.4.  Still have minor headache and some chills.  There is still a pinkish/red area about 2 inches long and 1 inch wide on my arm where the vaccine was given.   I did have a covid exposure at work last week and the employee health is going to test me before I go back to work.
After 9 days the spot on my arm where I received the vaccine began swelling, is red and itchy.  Today (next day) I am experiencing chills and a headache.
Swelling, redness, warmth at injection site later in the day of injection. With swelling of 1/3 upper left arm and deep aching pain over the next 1-2 days.
Within a couple of minutes of vaccine administration, the patient began experiencing throat tightness and stated that it felt like "there was a lump in my throat". BP initially was 168/81 and then continued to increase to 217/94.  O2 sats remained stable but Benadryl 50mg administered PO for potential allergic reaction. RN remained with pt for approximately 1 hour and pt eventually returned to baseline and was allowed to go home.
Profound Hyperglycemia and increased insulin needs on day 2 & 3  Day 2 insulin dosage increased from usual 25.5 on day 1  to  39.9 units  day2, to 30 units day 3, back to 26.9 on day4.  Sugars reached a High of > 330mg/dl with no dietary indescretions( such as High fat meal which cause delayed hyperglycemia, Excess carbs or extra sancking.).  Able to bring down Profoundly HIgh sugars on Day 3  With limited intake, increased calorie free fluids and increased insulin
died from the your vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died from the your vaccine) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 14-Jan-2022 The patient died on 14-Jan-2022. The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported.  No treatment information was provided.  Company Comment: This is a spontaneous case concerning a female patient of unknown age with no medical history reported, who experienced the unexpected serious event of death. The event occurred at an unknown time after a dose of mRNA-1273 vaccine. Cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to death and important medical event.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no medical history reported, who experienced the unexpected serious event of death. The event occurred at an unknown time after a dose of mRNA-1273 vaccine. Cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to death and important medical event.; Reported Cause(s) of Death: Death NOS
Pt received varicella vaccine on 5/12/98. She developed chickenpox on 4/5/02. Rash lasted shorter than usual and was lighter-spread than usual. Several unvaccinated siblings also had chickenpox at the same time.
3 min after vaccination, pt complained of blurry vision. endorsed tingling down his back and arms. felt he was getting very hot. itching down back of his head into his arms. reported pain in his throat, dificulty swallowing, felt like something was stuck in his throat. felt he had an upset stomach but did not think he was going to vomit. denied trouble breathing in his chest. no lip swelling, no eyelid swelling, no hives. pulse regular. 74. BP 150/70. O2 sat 98%. 0.3mg Epi given to right thigh at 1432. pt complained he still had globus, still had blurry vision, itchiness and was feeling even hotter. BP 180/90 at 1435. reported "hammer to his head" headache at 1437. cotninued blurry vision and globus. BP 172/94 at 1438. 0.3mg Epi given to left thigh at 1438. 1440 pt getting very shaky, handoff given to ambulance.
This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unknown date, the unspecified number of patients received unspecified doses of PNEUMOVAX, (dose number, lot/batch number, expiration date, route of administration not reported), that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.06 hours cumulatively (also reported as 15C for more than 59 hours) through 07-MAY-2014. It was reported that also M-M-R II, GARDASIL, ROTATEQ, and PEDVAX were improperly stored (event captured in MARRS#1405usa012894, 1406USA000955, 1406USA000957, and 1406USA000958 respectively). No adverse effects were reported.   Follow-up information has been received from the Registered Nurse. It was reported that the nurse was inquiring about temperature excursions that occurred from October 2013-March 2014 (previously reported as 20-MAR-2014 to 07-MAY-2014). The nurse also stated they were replacing the refrigerator, freezer, and the data logger and were sending the old data logger for calibration to the health department.   Follow-up information has been received from the Registered Nurse on 27-JUN-2014. The reporter stated that on an unknown date one patient received PNEUMOVAX lot # J009723 and exp date 30-JAN-2015 (also reported as 31-JAN-2015) which was stored improperly (highest temperature: 9C, number of hours prior to administration: 18 hours) for a period from 28-AUG-2013 until June 2014 (previously reported as October 2013-March 2014). This is one of several reports from the same reporter.  Additional information is not expected, as correspondence was returned by post office.
Pt recvd MMR/DPT/OPV 12SEP90; On approx 22SEP90, pt exp transient, migratory arthralgias involving ankles, elbows, wrists, & knees, which were not assoc w/signs or sx or arthritis; tx APAP; Lyme disease test neg;
COVID positive with mild infection; Difficulty breathing; Nose bleed; A spontaneous report was received from an 82-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nosebleed, difficulty breathing and COVID positive with mild infection.  The patient's medical history included Pulmonary arterial hypertension and Concomitant medication include TREPROSTINIL SODIUM and TADALAFIL. Lab tests provided for COVID-19 tests positive.  On 26 Jan 2021, patient received first of two planned dose  and on 16 Feb 2021, received second of two planned dose.  On 13 Mar 2021, the patient was hospitalized with nosebleed, difficulty breathing and COVID positive with mild infection and the treatment provided was unknown.  Action taken with mRNA-1273 in response to the event was not applicable as the patient received both the planned doses prior to the event  The outcome of events, nosebleed, difficulty breathing and COVID positive with mild infection was reported unknown; Reporter's Comments: Very limited information regarding these events has been provided at this time. Based on the known causative agent of COVID-19 infection, the event is assessed as unlikely related to mRNA-1273. It is likely that the patient was already infected with the virus but asymptomatic before being administered with the mRNA-1273 vaccine
Information has been received from a a physician concerning a 7 month old female with no drug allergies who on 16-JUL-2007 was vaccinated with a 2ml oral dose of Rotateq. On 14-AUG-2007 the patient developed intussusception characterized by vomiting, low grade fever, and bloody diarrhea. Medical attention was sought via emergency room visit and the patient was hospitalized. Numerous tests (unspecified), confirmed a diagnosis of intussusception and a partial iliac resection was performed. Subsequently the patient was noted to still be hospitalized and recovering. There was no product quality complaint. The event was also considered to be immediately life-threatening and other important medical event (surgery) by the reporter. Additional information has been requested.  08/31/2007 Received hospital medical records of 8/14-8/22/2007.  FINAL DX: Intussusception w/terminal ileum perforation & necrosis. Records reveal patient experienced fever & decreased oral intake x 4 days, 1 day of bilious emesis & 1 episode of bloody stool. Taken to OR for exp laparotomy, small bowel resection & appendectomy.  Admitted to PICU post operatively.  Received IV antibiotics via PICC line & was weaned from mech ventilation successfully.  TPN started &  progressed to oral feeds.  Tolerated feeds well & stooling normally.  D/C to home w/pcp & peds surg f/u.  10/2/07 Received vax record from hospital which reveals patient did not receive RO on any date.  5/1/08 Received PCP medical records for 1/24/07-3/3/08 which included vax record different from that received from hospital. but still confirm that patient did not receive Rotateq vaccine at any time.  7/27 visit for wheezing, runny nose & cough x 3 days.  8/13 visit, had been out of state.  Had vomiting & fever x 2 days & seen in ER out of state x 2.  Lethargic & seen in local Er day before.  Dx w/viral gastroenteritis.  8/16 notified of hospitalization.  8/31 f/u hospitalization vs progressing well.  Returned 9/6, 10/18, 10/29, 11/26, facial cellulitis, atopic dermatitis w/wheezing, couth & runny nose.
Rash to face and left arm; swollen lymph node to right arm; febrile and flushed; febrile and flushed; sweats and chills; sweats and chills; nausea; vomiting; diarrhea; muscle and joint pain; muscle and joint pain; severe headache; generalized weakness; swollen eyes; insomnia; This is a spontaneous report from a non-contactable other hcp (Nurse). A 31-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via intramuscular, administered in arm right on 07Jan2021 14:15 (age of vaccination: 31-years-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient previously received first dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient tested covid post vaccination. The patient has non known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included diphenhydramine hydrochloride (BENADRYL), naproxen (NAPROXEN) and paracetamol (TYLENOL). The patient experienced rash to face and left arm, swollen lymph node to right arm, febrile and flushed, sweats and chills, nausea vomiting diarrhea, muscle and joint pain, severe headache, generalized weakness, swollen eyes, insomnia on 07Jan2021 at 07:00 PM. Treatment received otc medications, prednisone rescue regimen and muscle relaxants. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Jan2021. The outcome of all the events was recovered with lasting effects on unspecified date.  No follow-up attempts are possible. Information on batch/lot number cannot be obtained.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 18-JAN-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018, status albumin: recombinant human albumin (rHA)). Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742.
Pt received first covid19 pfizer vaccination 11/3/2021 and woke up 11/4/2021 with R arm numbness (entire arm) and tingling. she has tenderness at injection site that is mild-moderate w/ palpation. she is experiencing moderate-severe fatigue that interferes with her ability to work today. she has entire back pain/aches as well.
Patient was given Daptacel (instead of Adacel or Boostrix).
High temp, rapid pulse.  Admitted to hospital with c-reactive  protein level of 891.  Head ache extreme especially activated with sound or light.  For five days they ran every test they could think of to find cause of my symptoms?..even though I told them I had just had an RSV injection.  After five days and no positive results for any disease or condition it was divided it must have been an allergic reaction to shot.  As soon as I was given steroids intravenously, I started to improve.  After 5 days in bed I also picked up pneumonia so antibiotics were also prescribed.  A day and a half later, I was discharged from the hospital.
5 minutes after flu shot pt experienced nausea, lightheadedness, diaphoresis, BP 89/50, slurred speech, confused.
Initial adverse event occurred 25 minutes after injection. Sudden confusion, burning heat and hives and burning red rash spreading from injection site, up neck and throat and down arm to hand. 5 days after the injection, a severe allergic reaction occurred where my entire body broke into hives and a red burning rash, again starting at the injection site. Throat tightness, itchiness in scalp and groin, and difficulty concentrating (all my usual symptoms of anaphylaxis) occurred. Advised by health care provider to take Benadryl immediately and to have epi-pens on hand. Loratadine was prescribed.
Feeling lower back pain, groin pain, joint pain, headache, fatigue morning after vaccination
I had extreme chills all night. I felt extremely ill and very weird. The symptoms started around 08:00PM. It started improving around 06:00AM the next morning. By about noon, the reaction was almost gone.