chrisvoncsefalvay/vaers-outcomes huggingface dataset:
20 month old patient received a quadracel vaccine on his 12th month instead of pentacel, this is supposedly his 4th dose on his pentacel series with no reported adverse event; Initial information received on 02-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 months old male patient and is reported 20 month old patient received a diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] on his 12th month instead of pentacel, this is supposedly his 4th dose on his pentacel series with no reported adverse.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Aug-2022, the patient received a dose 0.5 ml TOTAL of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine Suspension for injection strength, expiry date: not reported lot C6002BA via unknown route in left leg for Immunization.  On 22-AUG-2022 the patient developed a non-serious 20 month old patient received a quadracel vaccine on his 12th month instead of pentacel, this is supposedly his 4th dose on his pentacel series with no reported adverse event (wrong product administered) on the same day.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event 20 month old patient received a quadracel vaccine on his 12th month instead of pentacel, this is supposedly his 4th dose on his pentacel series with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Rash on hands and feet.   Spread to inner thighs, elbows, knees, and butt.  No treatment was given.   Tried to keep body temp down so that rash wasn't irritated and to minimize spreading.    Where the rash was present on hands has developed a peeling and has scarred on feet.
This case was reported by a consumer via call center representative and described the occurrence of chills in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 18th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills, general body pain, injection site itching and pain in arm. On an unknown date, the outcome of the chills and general body pain were recovered/resolved and the outcome of the injection site itching and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the chills, general body pain, injection site itching and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The patient experienced pain at the injection site, and was experiencing pain down her entire arm. The patient also experienced chills and body aches that lasted for about 2 days. The patient also had itching at the injection site which comes and goes. The reporter did not give consent to follow up. The patient was referred to her healthcare professional. No further details were provided.
severe fatigue, chills, fever 100.1, abdominal discomfort lasted 3 days
Patient received two flu shots within the same season. First flu shot on 10/4/21 and second flu shot 10/27/21. Patient states no symptoms or adverse events due to duplicate vaccination.
On 07/26/02, it was reported that a 4year old male patient received Daptacel (lot # C0725AA), administered IM in the right deltoid), IPOL (lot # U0823, administered Sc in the left arm), MMRII (lot 1545L, administered SC in the left arm) and VZV ( lot # 0289M, administered SC in the left arm) vaccinations on 07/22/02 at 12 PM. On 07/23/02 at 3 pm,the child's right deltoid was red, swollen, hot to touch, area measuring 65 X 80 mm. Treatment of cold compresses and Tylenol was advised. The patient reportedly recovered from this event.
dizziness / vomiting both occurring now paramedics called. Conference call operator / patient's daughter. Pt rcvd Covid vaccine 2nd dose yesterday.  patient having protracted vomiting/dizziness.  pt does get medication for dizziness regularly and has history of stress induced vomit.  pt not feeling well.  Daughter able to provide some of the information regarding vaccine but very nervous and d/c as soon as EMS arrived. Agency had recommended to have EMS evaluated and transport as needed. Adv pt should f/u w/PCP ASAP. Adv to call back if any questions. Adv daughter that she may get call back from PIC/Covid Hotline.
SORE NECK; SORE ARM; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, treatment medications included: paracetamol. On 16-MAR-2021, the subject experienced sore neck. On 16-MAR-2021, the subject experienced sore arm. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, sore arm, sore neck and fever was not reported. This report was non-serious.
This spontaneous report was received from a nurse via company representative refers to a 13 year old female patient. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were unknown. Approximately in 2006 (reported as 10 years ago), the patient was vaccinated with all the three doses of GARDASIL via intramuscular route. Nurse reported that after receiving the third dose, patient began having plantar warts on her feet; 9 on 1 foot, 13 on the other. The patient required medical attention. Nurse reported that they burned off the plantar warts. Outcome of the event was unknown. Reporting nurse had not assessed the causality of the event with respect to therapy with GARDASIL. Additional information has been requested.
This case was reported by a consumer and described the occurrence of adverse event in a female patient who received RABAVERT. On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, less than a week after receiving RABAVERT, the patient experienced adverse event and paranoid state. On an unknown date, the outcome of the adverse event and paranoid state were unknown. It was unknown if the reporter considered the adverse event and paranoid state to be related to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient received vaccine last night. The patient experienced some side effects and thought she was just getting paranoid. The patient wanted to know how long these side effects would last.
Slight swelling to bottom lip, white strands in mouth, chapped and split lips, dry rash below bottom lip and dry mouth - lack of saliva
Headache different than usual headache.  Given epi by alternate provider and she said she felt better.
I woke 15 hours after 2nd dose of Moderna with violent shaking and chills, fever and headache. Fever was 100.8. I took Tylenol it brought it down. I had to take Tylenol every 4-5 hours the next day or the fever returned.  The fever and bad headache lasted 24 hours. The chills and shaking stopped within 2 hours of first being awoken by them.    48 hours after the vaccine I developed a redness on my arm about an inch from the injection site. It grew in diameter to 4 inches. It was very hot to the touch and itchy. Today is day 6 from getting the vaccine and it is finally starting to fade and is not hot to the touch today. I am assuming it will disappear with a day or two.   I researched on the computer and saw that it is being called "covid arm".  I did not seek any medical attention knowing that the vaccine could cause these issues.
Extreme shoulder soreness.  Pain and discomfort.  Could not lie down.  Could not sleep.  3 Tylenol at 6:00 p.m. and ice. 3 Tylenol   at 9:30 p.m.  2 Tylenol and ice at 3:00 a.m.
Chills, skin on face and neck feels hot and looks flushed, muscle pain, headache.
1/14/2021 Pfizer Covid Vaccine #1 2/4/2021 Pfizer Covid Vaccine #2 3/13/2021 Exposure to Covid from Sister in Law 3/19/3021 Employee tested positive for Covid with symptoms with a PCR covid test Employee is pregnant with estimated due date of 8/28/2021
Vaccine given 12/9/2010, rash erupted 12/21/2010 peaked 12/30/2010 -> resolving 1/10/2011. Consistent with chickenpox. Patient comes in for acute visit due to rash. He had a shingles vaccine on Dec 9, 2010 here in this office. On December 21, 2010, he broke out in a pruritic rash across his chest and upper arms. The rash was little red bumps---never big vesicles, but was quite itchy and prevented him from sleeping the week after Christmas. (After the rash erupted, it seemed to spread and get worse until the day after Christmas and stayed pruritic until about New Year's Day). Reviewed patient's history with him--he was diagnosed by a physician when he was a young child with chickenpox. His daughter (a pt of mine) had chickenpox when she was a child, and he didn't contract the disease then. Currently, no longer itching and he has felt fine the entire time--no fever, URI symptoms or other systemic symptoms since the rash first occurred.
hallucinations on  night of 1-7-22 migraine with sensitivity to light, sound, nausea on 1-8-22  and 1-9-22,  Motrin did not help spine stiffness and extreme pain, difficulty walking  1-8-22 and 1-9-22,  Motrin did not help migraine stopped early morning hours of 1-10, but still have moderate spine pain and light-headedness, difficulty focusing eyes
Patient 1st dose was a ped vaccine (11 yrs old); recently turned 12 yrs old and was administered a ped PFizer, instead of an adult dose.
pain in his body/body aches; little bit of headache; tired; Fever; was not feeling well; coughing; sneezing; This is a spontaneous report from a contactable consumer (patient's mother) via medical information team.   A 33-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0173, expiry date: unknown), via an unspecified route of administration, administered in left arm on 03May2021 at 10:30 (at the age of 33 years) as dose 1, single for covid-19 immunization in hospital. The patient medical history included ongoing deafness from an unknown date. Reporter confirmed her son was deaf and he could not explain his symptoms before treatment with the Pfizer COVID 19 vaccine when he was younger, he had an issue with his airways and one of the infections affected his hearing when he was may be 3 or 4. Concomitant medications included daytime Cold medicine (unspecified name) (lot number: 9LT3314 and expiry date: May2021) taken for an unspecified indication, on an unspecified date at 08.00 and stop date were not reported, so now she was giving ibuprofen. The patient did not receive any prior vaccine within 4 weeks. On 03May2021, the patient experienced fever and did not feel good. On 04May2021, the patient experienced pain in his body, little bit of headache and tired. On an unspecified date in 2021, the patient experienced coughing and sneezing. The reporter reported that her son got the Pfizer Covid 19 vaccine on Monday, since yesterday he had a fever and did not feel good. He took cough medication because he did not feel well. The reporter asked if it was normal that he still had a fever and how long would be it lasted. The patient ran a fever maybe 11 or 12 at night the first day, and he still has a fever today and has pain in his body and a little bit of a headache. Caller clarified the product her son took was Daytime Cold and Flu Multi Symptom. The patient was no not doing worse. He also had a temperature now but not worse. The body aches started on 04May2021 and he was tired and it was same as yesterday. He just woke up, and he could not explain it was very well. States might be the headache was also because of the fever, but it was a little better than yesterday. The patient took a pill for the coughing and sneezing, and she told him not to because Tylenol or Ibuprofen was only recommended. Events did not resulted in visit to emergency room or physician office. Patient was planning to get the second dose on 24May2021. Therapeutic measures were taken as a result of fever, pain in his body, little bit of headache, coughing, and sneezing. The outcome of events fever, pain in his body/body aches and tired were not recovered. The outcome event little bit of headache was recovering. The outcome of events sneezing, was not feeling well and coughing were unknown.  No follow-up attempts are possible. No further information is expected.
After receiving the 4 months vaccines, patient developed redness on his legs. No fever. No swelling or hot to the touch at the moment. Patient was observed by clinician and was kept in the office until redness went down. Patient was fuzzy/crying the moment after vaccines were administered.
This spontaneous report was received from a physician refers to a 19 year old female patient. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 01-JUL-2016, the patient was vaccinated with the first dose of GARDASIL (dose, dosage number, route of administration, lot # and expiration date were not reported). No other suspect or concomitant therapies were reported. On an unspecified date in July 2016 (reported as 2 weeks later), it was stated that the patient felt light headed, felt weak and also experienced seeing black. At the time of the report, the outcome of visual impairment, asthenia and dizziness was unknown. The relatedness between visual impairment, asthenia and dizziness and GARDASIL was not reported. Additional information has been requested.
On 6/18/2021 resident had received 2 nd dose of Moderna vaccination. 6/19/2021- no adverse reactions noted. None reported. On 6/20/21 resident around noon,  reported to the floor nurse that he was unable to move right extremities both hand and leg. Resident refused to go to the hospital for further evaluation. Today, 6/21/2021  resident reported to this nurse that he still has no mobility to his right side. Resident had 2nd COVID vaccination (Moderna) on 6/18/2021 on his left deltoid.  Mini neuro check completed.  Resident's mental status is intact. Facial symmetry noted. When instructed to move right arm, resident was not able to pick up arm, unable to perform active ROM. Sensation is intact. Resident is able to discriminate pain, sensory stimulation is intact. Resident was asked to pick up and move right leg, resident was unable to perform the action. Sensation to RLE is intact. Resident was advised that he needs further evaluation but declined to go to the hospital. Resident stated his wife was made aware during visit yesterday and his wife  had asked him to go to the hospital but he refused to go. Provider was made aware of findings. Provider advised for him to be sent out to ER for further evaluation however resident refused to go. Resident's urine output in his urinal was also noted to be dark colored, blood-tinged. Provider made aware of labs on 6/19/21  which were WNL.Orders obtained for blood culture, and UA with C&S. Resident is in agreement with lab orders.  Orders were implemented and collected STAT. Lab results are pending as of writing.
This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies. On 10-DEC-2021, the vaccine experienced a temperature excursion of 48.5 Fahrenheit (°F) during a time frame of 4 hours 0 minutes and 0 seconds. On 29-NOV-2021, the patient was vaccinated with one improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe (lot number T039322, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 09-SEP-2022) (frequency, route of administration, anatomical location and vaccination scheme were not reported), as prophylaxis (product storage error). There was no previous temperature excursion reported or if a data logger was used. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-2112USA005896.
The pt developed an erythematous left injection site, was tender to touch and also experienced hives. Treated with warm compresses.
Patient complained of rash with bumps.  Patient was diagnosed with cellulitis at hospital ER. Patient filled prescription for antibiotic clindamycin and ondansetron for nausea.
Pt recvd 3rd dose of Hep B vax 17SEP92 & evening of 17SEP92 pt devel weakness resulting in rt lower extremity paresis, diffuse paresthesias of arms & from umbilicus downward & transverse myelitis; pt hospitalized;
Menstrual bleeding began two weeks ahead of schedule. Have been regular 28 day period for 20 years with no spotting; This is a spontaneous report from a contactable nurse, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the arm right on 20Jul2021 at 15:30 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN), cold sores, endometriosis and infertility. The patient was allergic to penicillin. Concomitant medication included labatelol (MANUFACTURER UNKNOWN) and famcyclovir (MANUFACTURER UNKNOWN), all from an unknown date for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Jul2021 at 08:00, the patient experienced menstrual bleeding began two weeks ahead of schedule. Have been regular 28 day period for 20 years with no spotting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event irregular menstrual cycle was unknown.
Pt recvd vax 1980 & lab eval in MAR91 revealed that rubella titer was borderline pos; lab eval on 10NOV92 revealed that rubella titer was borderline neg; 23NOV92 was admin a booster dose of rubella vax; no further details were provided;
Redness and swelling developed at injection site of DTaP within 24 hours of injection treated for cellulitis.
This spontaneous report as received from an other unspecified source refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored GARDASIL (lot # J003727, expiration date: 07-NOV-2015, dose and route not reported). This is one of several reports received from the same source (linked MARRS#s: 1310USA014881, 1310USA014883, 1310USA014891, 1311USA000056, 1311USA000071, 1310USA015417, 1310USA014897, 1311USA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA014866, 1310USA014868, 1310USA015422, 1310USA015165, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064, 1311USA000020, 1311USA000021, 1311USA000040, 1310USA015096, 1311USA000022, 1310USA015101, 1310USA014853, 1311USA000075, 1310USA014895, 1310USA015119, 1310USA015113, 1311USA000059, 1311USA004931, 1311USA000065, 1311USA000739). Additional information has been requested.
Patient has redness and swelling at the injection site that started this morning. She has been advised to place compress on the site and it should subside in a few days.
Thursday AM 20AUG had t105 went to ER MD stated there were no findings gave ATB just in case;
several pts under the age of 12 who were vaccinated w/varicella vaccine;subsequently, the pts devel lesions;No further details were provided;
no adverse event; products experienced an excursion of 4C fo 20 minutes; This spontaneous report was received from a registered nurse concerning a 4-year-old patient. The patient's medical history, concurrent conditions, and concomitant medications were not reported.   On 11-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), lot # U015682, expiry date: 18-MAY-2023, for prophylaxis. The dose was stored  between -10 to 8 degrees celsius (C) (4 C) for 20 minutes. A previous temperature excursion showed the dose was stored between -10 to 8 C (4 C) for 7 hours and 30 minutes.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2109USA005628: US-009507513-2109USA005662: US-009507513-2109USA005648:
Vaccine administration error. The vaccine was given to a 16yr old. Licensed for 18 years +.
Horrible. Thought I was going to die. My muscles were paralyzed or frozen I could not even move. I thought I was going to die. I had trouble walking. Had the chills and fever that finally broke after 2 days. My left arm was painful all the way down to my wrist. My throat was dry and hard to swallow.  I also have a cough. I also had headache 24 hours. Felt nausea but never threw up..  No energy for 3 days
dizziness, chills, nausea, exhaustion, rapid heartbeat Symptoms lasted approximately 24 hours.
Severe muscle ache, chest pain, could not put arms above head, arm pain. Mom gave 800mg ibuprofen and fluids. This was injection #2 and same reaction happened with the first immunization.
pt recv vax & fell asleep;pt awoke 11AM screaming & crying, should not eat nor stop crying;someone had to hold pt;given APAP;dx local rxn to tetramune;leg as sl red & puffy;sleeping alot next day;hypotonic;legs & trunk weak;
My period came over a week early after my second shot. I then got my period again less than 3 weeks later. My periods are always completely regular.
Hip pain almost like possible arthritis (although I have never had arthritis). Some difficulty in walking.  immflammation of lymph nodes under right arm discovered in routine mamogram. Also, benign cyst is left breast discovered. No history of such in the past.
This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 12Mar2021 08:30 (at the age of 50-year-old) as dose 1, single for COVID-19 immunization, at other facility. The patient medical history included fibromyalgia. Concomitant medications included gabapentin (GABAPENTIN), spironolactone (SPIRONOLACTONE), and duloxetine hydrochloride (CYMBALTA). The patient had no known allergies. The patient received no other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. On 12Mar2021 08:30, the patient experienced chest and throat tightness along with dizziness. No treatment was given for the events. The outcome of the events was reported as not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
patient complained of chest pain, difficulty breathing, racing heart rate, dizzy. She said it lasted for 5-10 minutes then went away