chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she experienced heart palpitations; This non-serious case was reported by a consumer via call center representative and described the occurrence of palpitation in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-JUL-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown arm) .5 ml. On 28-JUL-2023, 4 hrs after receiving Shingrix, the patient experienced palpitation (Verbatim: she experienced heart palpitations). The outcome of the palpitation was not resolved.   It was unknown if the reporter considered the palpitation to be related to Shingrix.     It was unknown if the company considered the palpitation to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-AUG-2023 The reporter was the husband of the patient. The reporter stated that his wife received second dose of Shingrix vaccine and that evening she experienced heart palpitations. The reporter mentioned that the palpitations were not constant but they have not gone away either. The patient would go to see the doctor tomorrow. The reporter consented to follow up.
No additional AE details or PQC.; PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion; This spontaneous report as received from a healthcare business, referring to a patient of unknown age and gender. The patient's pertinent medical history, current condition, previous drug reaction or allergy, and concomitant medication were not reported.  On 11-APR-2022, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection (strength, dose, route of administration and anatomical site of vaccination were not reported, lot number U022819, expiration date reported and validated as 14-JAN-2024) for prophylaxis (product storage error). The vaccine was exposed to the temperature excursions: 70 degrees Fahrenheit for 96 hours. There was no previous temperature excursion. No additional adverse event details.
This case was reported by a consumer and described the occurrence of headache in a female subject of unspecified age who was vaccinated with HAVRIX 1440 (GlaxoSmithKline). Concurrent medications included SYNTHROID and Pravastatin. On 26 February 2014 at 13:30 the subject received 1st dose of HAVRIX 1440 (1 ml, unknown, right arm) and experienced expired vaccine used. The subject reported that her pharmacy accidentally administered an expired HAVRIX vaccine. On 26 February 2014, within hours of vaccination with HAVRIX 1440, the subject experienced headache, nausea, fatigue and expired vaccine used. After the vaccination, sometime after dinner, she felt some fatigue, nausea and headache. The headache has resolved, but she is still experiencing some nausea. According to the subject immunization series was not delayed or discontinued. At the time of reporting the headache was resolved, the nausea and fatigue had improved. On 28 February 2014, the case was medical confirmed by the pharmacist who reported the subject experienced headache and nausea after receiving expired HAVRIX. HAVRIX batch and lot number were not provided. The pharmacist inquired about a replacement dose. No additional information was provided.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUL-2016, the patient was vaccinated with the improperly stored dose of M-M-R II (lot # L026553, albumin status rHA; dose, route, expiration date were not reported). This is one of several reports received from the same reported. Additional information has been requested.
Patient come in for her second dose of Covid vaccine, complete the Moderma paper when patient have her Pfizer vaccine, today patient recieved  a second doze of Moderma instead of Pfizer, we will follow up up with the patient
Musty, mildew smell, food tasted stale, funny taste in her mouth, ackey
Initial information has been received from a physician and follow up information has been received from a nurse concerning a female patient between the ages of 11 and 19 who was vaccinated with a first dose of Gardasil.  It was reported that the patient sat for a minute (after receiving the injection) and when she got up to leave she fainted in the hallway.  Her outcome was not reported.  The physician reported that lot numbers were not available, however, the physician will forward other information including the lot numbers.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007. Follow-up information has been received from a health professional concerning the 19 year old female student with no medical history who on 20Mar-2007 at 3:15 p.m. was vaccinated IM with her first dose of GARDASIL, lot # 655618/0186U. Concomitant medication included a second dose of VAQTA (manufacturer not reported). At 3:15 p.m. the patient experienced dizziness (also reported as within 5 minutes of administration the patient experineced dizziness). The dizziness lasted approximately 5 minutes. The patient laid down on teh exam table and walked out on her own after 10 minutes. Additional infomation is not expected.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No pertinent medical history and drug reactions/allergies were reported. On 28-AUG-2014, 28-OCT-2014 and on 18-SEP-2015, the patient was previously vaccinated with GARDASIL (strength, dose and frequency were not reported) (inappropriate schedule of drug administration). On 18-MAR-2016, the patient was vaccinated with GARDASIL 9 (extra dose administered and interchange of vaccine products). Concomitant medications were not provided. No adverse effects were reported. There were no product quality complaints (PQC) involved. No further information provided. Additional information is not expected as the reporter did not wish further contact.
tired; feeling crummy; chills; Injection site hurt; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown) solution for injection, via an unspecified route of administration on 30Jan2021 at 11:00 AM at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her vaccine on Saturday, 30Jan2021 at around 11:00 AM and at about 4:30 PM, she started getting really tired and feeling crummy. She had chills, fatigue, and tiredness. She went to bed and slept the rest of the day. She read that they were side effects and was not too worried about it. On Sunday, 31Jan2021, the patient felt fine and then she had chills and felt crummy again; she took another nap. Today, 01Feb2021, she felt crummy again and had on and off chills. She was asking if this was normal. It was stressing her out. The injection site was also hurting on Saturday (30Jan2021), it was really sore. Other people that she knew did not have these symptoms until the second shot. The patient was concerned about getting her second shot. The outcome of the event fatigue was unknown and not recovered for all other events.   Information on the lot/batch number has been requested.
Post vax pt was covered with a red rash on his head, face, chest and legs, arms and buttocks looks like chicken pox. Red and raised . He did have a rash on his stomach prior to arms. Temp 99.
On 06/05/2022 I woke up feeling a bit stuffy, congested, and had a runny nose. I attended a granddaughter's birthday party that day, but since I wasn't feeling well, I wore a mask and kept my distance from others. My symptoms persisted through the next few days but continued to be mild. By the following Tuesday, I took an at home COVID-19 test which was positive. I took another for confirmation and it was also positive. I called my primary care physician's office and spoke with an on call doctor over a telehealth visit. She prescribed a 5 day round of PAXLOVID. I began taking the medication later that day. After two days, 06/09/2022, I was beginning to feel quite a bit better. By Sunday, 06/12/2022, I began to test negative on at home COVID-19 tests.
was given to a 16 month old, administration to patient younger than what it is indicated fo with no reported adverse event; Initial information received on 12-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health care professional.  This case involves a 16 months old female patient who experienced was given to a 16 month old, administration to patient younger than what it is indicated fo with no reported adverse event while receiving Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hib Vaccine Conj (Tet Tox)(Acthib)for Prophylactic vaccination.  On 12-Apr-2022, the patient received a dose of  0.5 ml, frequency: once (1 day)of suspect Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel] suspect ion for injection (lot-C5970AA)(expiry date:02-02-2024)(strength : unknown) via intramuscular route in the right thigh.  On 12-APR-2022 the patient developed  non-serious event was given to a 16 month old, administration to patient younger than what it is indicated fo with no reported adverse event (off label use) following the administration of Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (was given to a 16 month old, administration to patient younger than what it is indicated fo with no reported adverse event).  At time of reporting, the outcome was Unknown for the event was given to a 16 month old, administration to patient younger than what it is indicated fo with no reported adverse event.
Case number PHEH2014US01544 is an initial spontaneous report received from a healthcare professional on 11 Jun 2014. This report refers to a 17-year-old female patient. She received only powder component of MENVEO (batch number: M13014, expiry date: Sep 2014) mixed with sterile diluent instead of Men CYW-135 liquid component on 10 Jun 2014. No adverse event was reported following this medication error.
experienced lots of bleeding when he was injected; a little sore in the injection site; swelling at the injection site; lump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (experienced lots of bleeding when he was injected), VACCINATION SITE INDURATION (lump at the injection site), VACCINATION SITE PAIN (a little sore in the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (experienced lots of bleeding when he was injected) and VACCINATION SITE PAIN (a little sore in the injection site). On an unknown date, the patient experienced VACCINATION SITE INDURATION (lump at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). On 22-Feb-2021, VACCINATION SITE HAEMORRHAGE (experienced lots of bleeding when he was injected) outcome was unknown. At the time of the report, VACCINATION SITE INDURATION (lump at the injection site), VACCINATION SITE PAIN (a little sore in the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
After injection, patient did not feel well and fainted as she fell to her knees and caught by employees. Unresponsive for a few seconds.
NOV96 pt c/o numbness in the fingers & hands;10NOV96 to 11NOV96 pt c/o not feeling right, inc numbness in the feet & calves & walking diff (frunk duck walk); 12NOV96 pt was adm to hosp for s/s of inc BP;could not walk;dx GBS;
Irregular period starting the following week on 5/24. 24 day cycle when usual cycle is 28 to 29 days.  Then started next menstrual cycle on 6/22 (at normal 29 day time frame) BUT cycle only lasted 1 day.  Have been menstruating 33 years and have never had just 1 day of bleeding.  Normal bleeding for me lasts 5 days.
Information from a physician concerning a 71 year old male pt with a history of immunization with a first dose of pneumococcal 23v polysaccharide vaccine in 1997 who on 08Sep03 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On09Sept03 the pt was seen in the office with a very red, warm and swollen (about 20cm in diameter site) arm. There was no therapy prescribed and the swelling went away in a day or two. The pt was seen again in the office for follow up. It was noted that the pt had no systemic symptoms. The reporter requested analysis of the vial or retention stock. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The reporter also indicated a similar experience with another pt. Additional information has been requested.
100  DEGREE TEMP.  BODY ACHES,  DISORIENTATION,  SUBSEQUENTLY A RASH ABOUT 2 1/2" DIAM.
Swollen lymph nodes in left armpit, severe joint pain, chills, slight headache.
PATIENT STARTING FELLING DIZZY, THEN FAINTED. WHEN SHE CAME AROUND , SHE STARTED FEELING NAUSEOUS AND LATER VOMITTED.
pt recvd vax 13APR95 1115AM & 15-20mins later could taste it describing it as a bitter taste;asked if has any tightness in throat or SOB; stated felt lightheaded & looked pale; observed 10 mins; BP 174/90; exp diarrhea & h/a
Left deltoid area induration 10- to 15cm with swelling and erythema, fine vesicles around the injection site. po benadryl ,  Po Motrin for pain and cephalexin for possible bacterial skin infection and  celluitis
This spontaneous report as received from a pharmacist concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 28-MAR-2019, the patient was vaccinated with M-M-R II (rHA) lot # N014483 with expiration date of 10-MAY-2019, 0.5 milliliter once, via intramuscular route for prophylaxis. The vaccine was reconstituted with Merck sterile diluent, lot number N022038 with expiration date of 27-NOV-2019. No adverse effects were reported.
Itching, redness, swelling at injection site.  Showed up exactly one week after vaccine injection was administered.
Site of injection is red, sore, on abdomen, I have a few red welts.
patient received the first dose of GARDASIL 9 in Aug 2019 and then never received anymore doses; no adverse event; This spontaneous report was received from a pharmacist referring to a currently 14-year-old patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On an unknown date in August 2019, the patient received the first dose of HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), administered once as prophylaxis (strength, route of administration, anatomical location, dose, lot number and expiration date were not reported) and then never received any more doses (Inappropriate schedule of product administration). No additional adverse event was reported (no adverse event).
A red itchy rash appeared all over body, child cranky and fussy. Thighs did swell more than with previous shots. Rash has persisted more than a week and worsens if Benadryl is not given. Maculopapular reddish and reticulated palpable rash over face, trunk and proximal extremities. Eczema worsened too.
SHORTLY AFTER THE ALLOTTED 15 MIN OBSERVATION TIME, I LEFT PHARMACY TO GO HOME AND BEGAN HAVING A FEELING OF NUMBNESS IN MY UPPER LIP AND NOSE AREA. THIS CONTINUED THROUGHOUT THE EVENING AND EVEN STILL TODAY THE LOWER PORTION OF ONE NOSTRIL STILL FEELS NUMB AS THOUGH I HAVE BEEN THROUGH A DENTAL PROCEDURE (WHICH I HAVE NOT)   THERE ARE NO OTHER SYMPTOMS EXPERIENCED OR ISSUES WITH BREATHING, ETC.  I'M NOT OVERLY CONCERNED BUT WANTED TO REPORT THIS  REGARDLESS.
This is a spontaneous report from a contactable consumer (Consumer's wife). A contactable 74-year-old male patient received PREVNAR 13 on 13Feb2017 at single dose for immunization via an unspecified route. Medical history included gout, ongoing and thyroid. Concomitant medication included allopurinol 300 mg, 1x/day, orally and aspirin 325 mg, 1x/day both were taking over 10 years and ongoing and levothyroxine 25 mg, 1x/day and ongoing. On the same date the patient experienced stroke like symptoms. The patient referred to the hospital and he was tested and it wasn't stroke, the vaccine caused those symptoms. A MRI was done at hospital and the patient had a blood work done on 17Feb2017 both with unknown results. The outcome of the event was unknown.
Painful Sores in Mouth; Initial Report Received on 09-Sep-2022  A nurse practitioner reported that a 38-year-old male patient (race and ethnicity unknown) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then developed painful sources in his mouth.  Medical history and concomitant medications at the time of vaccination were unknown. The patient had an allergy to amoxicillin, which caused a rash.  On 01-Sep-2022, the patient received the first dose of HEPLISAV-B (Lot # 937781, expiration date 20-Sep-2023, NDC # unknown) intramuscularly in the left deltoid.   On 02-Sep-2022, one day after receiving the HELPLISAV-B injection, the patient developed "pretty painful" sores in his mouth. The reporter denied that the patient had any other adverse reactions.  At the time of the report, the mouth sores were almost gone.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
From initial information received on November 21, 2003 from a consumer regarding an adverse event occurring in USA, it was reported that a 74 year old male patient received Fluzone SV '2003-2004' USP, lot number U12699AA, administered intramuscularly in the left arm on October 13, 2003.  The next morning on October 14, 2003, the patient stated that he had developed hives on his torso, itching and his penis was "full of fluid".  He was seen by a physician on an unspecified date.  The recovery status of the patient is unknown.
Lot of pain in his chest and his entire body; Sore throat; Muscle ache; Lot of pain in his chest and his entire body; had a really bad night, bad afternoon yesterday; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old male patient had received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0168, Expiration date: Unknown) via an unspecified route of administration on 16May2021 as Dose 1, Single for Covid-19 immunization. The patient's medical history and concomitant were not reported. On an unspecified date in May2021, " reporter mentioned that the patient had a really bad night, bad afternoon yesterday and experienced a lot of pain in his chest and his entire body, sore throat and extreme muscle ache. He was little better (today) but, the reporter just really does not know what to do like she knew he was breathing but, she does not know if this was normal, queried if she should wait for another day. " The clinical outcome of the events were unknown.  No follow-up attempts are completed. No further information is expected.
Pain in left arm within 30 minutes of administration. General tiredness/lethargy within10 hours (upon waking next morning).  Sore/stiff neck within 14 hours.  Body aches, chills within 16 hours.  Stomach/abdominal discomfort within 20 hours.  Diarrhea at 36 hours. At 36+ hours - arm pain considerably less. Body aches and chills gone by 36 hours.  Continued stomach/abdominal discomfort seems to be improving after 40 hours.
1wk p/vax severe allergic rxn-hives-MD treated w/anti-histamines;2 days later hives, breathing diff, vomiting required emergency room visit;next day, return of hives & vomiting;next day began to improve somewhat, MD stated believed d/t MMR
The injection spot became swollen, red, itchy and heated. The pain was preventing normal arm movements. The symptoms started to fade on the 6th day after the vaccination.
prolonged crying, diarrhea;painful, swollen rt leg from knee to thigh;
lt arm edema from shoulder to elbow, erythemic patch to posterior lt arm, lt elbow; neuropathy to lt ring & little finger;dx DTH rxn to anthrax vax, cellulitis;
swelling of the lips, congested sclerae, generalized pruritus w/in 25min of vax;epi given;solumedrol & DPH, proventil given;d/c from ER 2 1/2hr later w/med;
Patient had 102 temp on 2-4-07. Tylenol given temp decreased. 2-5-07 mother report multiple red spots. 2-7-07 mom brought child into health dept. Noted multiple red spots in hair, face, arms, trunk, legs.
Late in the day after receiving the vaccine the pt complains of pain at injection site.  The next morning the patient has swelling, redness, fever on arm of injection site.  Pain was excruciating and lasted 4 days with streaking down to the lower arm.
The patient was administered a volume of 0.25mL instead on 9-7-22 of the intended volume of 0.5mL. The error was recognized the next day and action was immediately taken to reach out to Moderna and CDC for clinical recommendations on the appropriate steps forward. On 9-16-22 responses were received, with the direction to have the patient come back as soon as possible to repeat the dose to receive the full dose of 0.5mL.  No adverse effects were reported. The patient returned and received the full dose on 9-17-22.
Diarrhea Information has been received from a physician concerning a patient who was  was vaccinated  with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). The physician reported that the patient subsequently developed very slight diarrhea. It was unknown if medical attention was sought. At the time of this report the outcome was unknown. Additional information is not expected.
While student teaching, exposed to chicken pox; broke out 20 spots across chest and belly 12/18/03.
Approximately 3 weeks after booster, patient developed sores in mouth.  Next day, sores spread to lips and throat, and target like spots appeared on arms, trunk and legs.  At that point Dr. prescribed 400 mg acyclovir 3x daily.  Symptoms continued to worsen, especially lips which were oozing blood, cracked, and blackish. Patient couldnt eat, barely open mouth enough to drink. Another pediatrician saw him and diagnosed him with chicken pox, disseminated herpes virus and impetago, and prescribed 800 mg acyclovir 5x and augmentin. A herpes lesion on his face very close to the eye seems also to have caused eye involvement and an opthamologist prescribed viroptic.  Patient lost approx. 18 lbs in 12 days until lesions on mouth and throat began to heal.  No fever or headaches.  A few teardrop chicken pox vessicles on chin and arms, rest of the spots on body were like bullseyes.  Itchiness reported just for 2-3 days and then subsided. Patient was unable to sleep for any length of time throughout the 10 day period due to great discomfort of the mouth, lips and throat.Patient has now basically recovered other than residual tiredness, not quite back to regular strength. About 10 days after innoculation, patient was exposed to sunlight, was on a beach for quite a number of hours and returned with a sunburn.