chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started with extreme sore injection spot, itching and swelling. Then large itching welts on my hands and head. By 8/31/2011, I had a headache due to pressure on my head from welts, and face started swelling - eyes swelled shut on 9-1-11 - causing me to miss 3 days of work. Treated with massive steroids (oral & injected).
Headache, Sedation, Myalgia, Chills, pain at the injection site Narrative:  Other Relevant History:
received 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient might have inadvertently received a 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.
sores on upper lips; lightheadedness; Diarrhea; blurred vision; pressure in abdominal area; soreness and itching at the injection site; itching at the injection site/itching is also present around the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th May 2020, the patient received the 2nd dose of Shingrix (intramuscular). In May 2020, less than a week after receiving Shingrix, the patient experienced injection site pain and injection site itching. On 28th May 2020, the patient experienced sores lip, light headedness, diarrhea, blurred vision and abdominal discomfort. On an unknown date, the outcome of the injection site pain, injection site itching, sores lip, light headedness, diarrhea, blurred vision and abdominal discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site itching, sores lip, light headedness, diarrhea, blurred vision and abdominal discomfort to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in the left arm. Since 28th May 2020, 2 days after vaccination, the patient had been experiencing sores on upper lips, lightheadedness, pressure in abdominal area, diarrhea, and blurred vision. The patient also experiencing soreness and itching at the injection site.  The itching was also present around the injection site. The reporter did not consent to follow up. No other details were provided.
Patient developed an infection (cellulitis) same thigh as injection. Was hospitalized, treated with IV antibiotics and then sent home on oral Keflex. Medical Record received on 12/15/2004 states symptoms include pain in right thigh from entire anterior aspect of thigh from top of knee to mid-thigh level, right back, fever, of 103.7. Ultrasound of thigh revealved subcutaneous edema.
rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash at injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041620A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced INJECTION SITE RASH (rash at injection site). At the time of the report, INJECTION SITE RASH (rash at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Two days post vax, the pt experienced left arm swelling, redness, induration and warmth to the touch. No fever and no cellulitis were noted.
swollen deltoid mass 40cm area; hot, painful started hurting w/in 48 hrs of inj; ice packs
The usual headache, nausea, fatigue, but the worst was and still is four days later extreme to the point of screaming with any kind of movement, pain in my left arm.  I need help getting dressed and can't pull up my own pants without a little cussing and groaning.
Post vax, the patient developed 5 or 6 chicken pox. The patient sought medical attention. Additional information has been requested.
Hives, sensation of throat closing, Given epinephrine x 2 and taken to hospital.
Patient administered with vaccine that have undergone temperature excursion; First dose on 30-Nov-2021 and second dose on 04-Feb-2022; Patient administered with vaccine that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine that have undergone temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered with vaccine that have undergone temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 30-Nov-2021 and second dose on 04-Feb-2022) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Feb-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine that have undergone temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 30-Nov-2021 and second dose on 04-Feb-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered with vaccine that have undergone temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine that have undergone temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered with vaccine that have undergone temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 30-Nov-2021 and second dose on 04-Feb-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  The expiry date of vial was reported as 27-Mar-2022 and also reported that the vial was thawed on 28-Jan-2022. It was reported that vial were stored in refrigerator at the time of the excursion and maximum or minimum temperature reached as on 28-Jan-2022 temp range: positive 34.7 F to positive 41.2 F; on 30-Jan-2022 temp range: positive 34.7 F to positive 41.2 F which occurred approximately for 48 hours; on 31-Jan-2022 temp range: positive 34.7 F to positive 41.2 F for 12 hours and on 04-Feb-2022 temp range: positive 35.2 F to positive 41.7 F for 12 hours. It was also reported that all vials were administered and patient reported no other adverse events.
Patient was given Covid Vaccine. She went to the waiting area to sit for the 15 min wait. She then came to the front desk to inform us that her heart rate was elevated and wanted to speak to a nurse. We then notified the nursing staff and took her to a room to be evaluated. After about 15-20 min nursing staff asked front desk to call 911.
Information has been received from a consumer concerning her 3 month old daughter who on 25- Aug- 2008 was vaccinated with 2 ml oral dose of ROTATEQ. There was no concomitant medication. Within 24 hours of vaccination the patient developed vomiting and diarrhea that lasted 10 days after receiving ROTATEQ. The patient was brought to the ER but was not admitted. 5 days after vaccination she developed a fever which " spiked" 7 days after the vaccination. She also developed a urinary tract infection which the doctor believes may have been due to diarrhea. Laboratory test included urine culture. The patients condition improved with therapy and she recovered after 10 days from vomiting and diarrhea. No product quality complaint involved.
Pt developed arthritic problems in knees, back and neck with swelling. Pt developed fatigue. Pt developed severe joint pain to several joints. The pain travels and pt experiences loss of use of limb until the pain leaves or goes to another joint. Pt could not write or work or lift leg, etc.
CHEST PRESSURE, THROAT PRESSURE, NAUSEA, DIZZINESS. HX OF GENTAMYACIN AND HAS SIMILAR REACTION.VSS. CODE GREEN CALLED, PT RECD BENADRYL 50 MG AND ZOFRAN 8MG. REFUSED TRANSPORT
Patient stated, that after her Moderna she had the worst reaction that required her to go to the emergency room- she felts like "she was going to die."  Fever, shortness of breath, blurred vision. Shortly after also diagnosed with cancer.
EMS called to pt's house with increasing SOB; O2 sat home monitor showed sats of 76% on RA with pt's home monitor; placed pt on 15L O2 via NC; positive for COVID; pt treated in hosp with dexamethasone, remdesivir, lovenox; pt had increased O2 requirements; NC with intermittent BiPAP; pt's condition deteriorated and he was put on comfort care and passed away in the hosp
Seen at ER on 12/18/2012 around 11:40 PM with fever, congestion, as seizure activity. Pt was given 4mg of ATIVAN and transferred to medical center. Arrived at ER (0157 12/19/12) while seizing, approx 45 minutes. TYLENOL given at ER at 8:06 AM for fever. Highest temp at ER was 100.8 (R).
Fever of 101, body aches, chills, and headache with sinus pressure for twenty four hours after onset.
This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, the patients' were vaccinated with improperly stored M-M-R II (dose, strength, route, frequency, therapy type, lot # and indication unknown) (incorrect product storage). The vaccine was exposed to a high of 9.5 degree Celsius temperature for a time frame of 24 hours. No adverse events were reported. Data logger was involved. It was reported that there was no previous temperature excursion. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient was found deceased in garage. Neighbor who is a nurse did CPR until ambulance got there and took over, started IVs and pushed medicine and did CPR as well. Patient was pronounced deceased over th ephone with the JP and Police due to the icy weather conditions on Feb 16th 2021
PATIENT HAD  SEVERE RASH ON ENTIRE BODY AND WENT TO TREATMENT CENTER WHERE THEY PRESCRIBED  PREDNISONE 10MG TAB 4 QD X3 DAYS, 2QD X 6 DAYS, 1 QD X 3 DAYS, AND ZYRTEC 10MG 2QD
premature delivery; pregnant patient received a dose of GARDASIL 9 as a result of user error; This prospective pregnancy spontaneous report was received from a registered nurse and refers to a male neonate patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  The patient's mother became pregnant with the last menstrual period (LMP) on 31-MAY-2022 (conflicting information, also reported as 17-MAY-2022) and estimated date of delivery (EDD) on 07-MAR-2023. At the time of this report, her gestation was 36 weeks and 1 day.  On 08-FEB-2023, the patient's mother received a dose of rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, pre-filled syringe, 1 dose in a right arm, lot #U039529, expiration date: 09-AUG-2024 (strength, and route of administration were not provided) as a result of user error (captured in 2302USA002937). The nurse reported that hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was intended and there was not anything in regards to packaging or labeling that contributed to the error. The patient did receive the intended vaccine hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 1 dose in the left arm for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  The patient was born prematurely (gestational age 36 weeks 3 days) (premature baby) (conflicting information, also reported as term birth). His birth weight was 6lbs 8ozs.  The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown. The causal relationship between the event and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was unknown.  This is one of two cases from the same reporter. ; Sender's Comments:  US-009507513-2302USA002937:Mother's Case
Breakthrough COVID infection. Tested positive 07/13/2022. Asymptomatic.
Pt had swelling 2 site x 3-4 days; Knot disappeared but swelling remained; Unable to relieve pt w/APAP; Took to ER & was admitted;
Slight headache; trouble walking; Tired.; Body temperature; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6200,), via an unspecified route of administration in the left arm on 20Feb2021 at 09:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had allergies to medications, food, or other products (details unspecified). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EL9264), via an unspecified route of administration in the left arm on 30Jan2021 at 16:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19. Since vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Feb2021 at 07:00, the patient experienced slight headache, temperature 100.4 (unit unspecified), trouble walking, effected both knees and tired. The events resulted in doctor or other healthcare professional office/clinic visit. However, no therapeutic measures were taken as a result of the reported events. The clinical outcomes of the events slight headache, temperature 100.4 (unit unspecified), trouble walking, effected both knees and tired were recovering at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Large knot in the arm at the injection site. Arm was sore for 3 days after shot. Now a week later I have a large knot still in my arm and now the injection site is hot and a rash like area. Also the site is very itchy
Day after injection she has ear pain and tongue numbness. The following day she developed a small stye under right eye. Then the following day she had face pain and paralysis and delayed blinking.  And then the 4th day she went to the doctor and was diagnosed with Bell's Palsy.
This spontaneous report has been received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. It was reported by the pharmacist that on 02-APR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route of administration, and frequency were not reported), for prophylaxis.  A digital data logger was used. No adverse effects were reported. This is one of multiple reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014153: US-009507513-1706USA001714: US-009507513-1706USA001721: US-009507513-1706USA001722: US-009507513-1706USA001723: US-009507513-1706USA001719: US-009507513-1706USA001724: US-009507513-1706USA001725: US-009507513-1706USA001726: US-009507513-1706USA001727: US-009507513-1706USA001728: US-009507513-1706USA001729:
Developed left deltoid swelling, redness, warmth 5cm induration, s/p tetanus administration.  Home treatment ice, Motrin, Antihistamine.
Information has been received from a registered nurse concerning a 29 month old female who on 05/18/2000 was vaccinated with a first dose of varicella vaccine SC in her right arm. The nurse reported that on 10/11/2001, the pt developed chicken pox. The pt had 30-40 lesions all  over her body on her chest, abdomen, and legs. She did not develop a fever. The pt was treated with Beandryl and subsequently recovered. The nurse reported that the pt's sister also developed varicella post-vaccination with varicella vaccine. No additional info is expected.
Info has been received from a nurse, who is also the mother concerning her 18 month old daughter, who on an unknown date in August 2005 was vaccinated with a dose of varicella virus vaccine live. The mother reported that her daughter had a reaction to the recent vaccination with varicella virus vaccine live, which she described as a fever of 104 degrees Fahrenheit, a pox-like rash, and a severe injection site reaction. It was reported that the adverse event improved and the pt recovered on an unknown date. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional info has been requested.
Neuromuscular symptoms (poor balance, difficulty walking, tremors) increased within hour after shot.  Took Tylenol and vitamin C per pharmacist instruction.  Rested.  By 4 hours later, took another Tylenol for stiff neck, headache, closed sinuses, injection site pain.  By next morning (8/20/2021), symptoms remained with addition of fever, body aches, cold sweats, slight chest pain, inappetence.  Fever broke on 8/21/2021, but took the whole day to recoup.  Noticed on 8/22/2021 arm still hurts, raised red rash, itchy, hot.  Took a couple of days to go away, but neuromuscular problems remain heightened.
5/26/11 -> mild soreness. 5/31/11 -> increased soreness, tender to touch. 6/2/11 -> increased soreness, redness, increased hot to touch. 6/3/11 -> increased in size to 4" x 4" with increased pain, redness & warmth.
I have had 10 sinus infections since getting vaccinated in less than a year.  it started within two weeks of getting the vaccine. The firt I was sick for almost three then within two weeks of that infection I was sick again for over two weeks. Each one takes a minimum of 2 weeks to go away without antibiotics. I spent a large part of the following three months sick for many weeks until I started frequently taking antibiotics. I experience severe discomfort in my face, pain in my ears, very bad headaches, dizziness, 102-103 fevers each time I am sick. I experienced severe discomfort in my left ear and very painful headaches for several months following the vaccine even when I was not sick. I experienced disruption to my sleep as I had trouble falling asleep with severe pressure in my ear and head.Before the vaccine, I had not been sick for a year and it was a cold for a few days.  In the Fall of 2021, I took antibiotics four times in three months.  I have been to four ENTs and an allergist but they can not find the problem with what is causing this issue.
received one dose of Hepatitis A Harvix 1440 on 2/16/1999.  Experienced heavy vaginal bleeding for 5 days afterward.  I telephoned the office to report this experience.  I also told my attending Physician as I cointinued to have bleeding problems for the years afterward to date requiring several D&C's and a surgery.
Administration error 2nd booster of the Pfizer BioNTech vaccine is administered to a patient who does not meet the recommended age to receive the 2nd booster. Patient evaluated vital signs Pulso-84, SPO2- 97%.
Smallpox vaccination at 0915 3 March. Onset of L sided neck discomfort, mild within 24 hrs. On 5 March, at awakening, developed myalgias, chills, and diaphoresis along with continuing neck pain and had a syncopal event following vasovagal reaction. Brief unobserved LOC, no further myalgias/chills after syncopal event, but continuing mild muscular neck pain on side of vaccination.
My period is several days late.  I took a pregnancy test and it was negative.  I am normally very regular.
Throat felt like I had something stuck in it, I couldn't gargle or drink it away. I called my sister who is a nurse and she said to take Benadryl.  I also had chills and some body aches. After taking the Benadryl I slept most of the night but woke a couple of times because of a migraine. I took 50mg Sumatriptan at 2 am and again at 6 am. The following day I felt poorly, could not eat much,  but the feeling in my throat was getting better so I just stayed home from work and rested. I still have a dull headache today, two days later. A little throat irritation, but easy to swallow.
Patient said they developed some shingles on their left arm and a small amount on the right arm.  The symptoms where some itching and pain especially in sunlight. It lasted for about 2 weeks. The patient did not go to the doctor and waited for them to go away on their own. The patient had some minor scar that was visible at today's vaccination.
This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L016427 and expiration date 13-APR-2017; exact doses and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 34.4 Fahrenheit degrees (F) for 10 minutes on 11-MAR-2016, 35.6 F for 10 minutes on 03-AUG-2016, 35.6 F for 10 minutes on 20-AUG-2016, 35.6 F for 10 minutes on 23-AUG-2016 and 35.6 F for 10 minutes on 26-AUG-2016 before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
on day 7 after getting vaccine, injection site became extremely itchy. Over the course of the day became very red and swelling increased to size of a baseball.
Very heavy menstrual flow during the first cycle after vaccine, noticed small clots. This is a first time ever for me. Also, longer menses than usual by a few days.