chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 09-MAY-2013 (lot number: 672232/1495AA; exp date: 22-AUG-2014) (dose, frequency, route and site of administration were not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Pt said she has felt dizzy in the past from some vaccines (never happened with previous COVID-19 vaccination). Technician administered vaccine and pt felt well enough to go sit in the waiting area with her friend. About 1-2 minutes later the friend got the tech's attention and the tech noticied the patient was having a reaction. The tech got the pharmacy and the tech called 911. The pt was slumped forward in the chair passed out and had a loss of bladder. She had a pulse and was breathing. Her friend helped her down to the ground safely and the pt came alert. She felt dizzy and nauseous so she was moved to lay on her side. The EMT's arrived and the pt opted to go to the hospital to get checked out.
Extreme pain for 5 days now and still be pain can't lift left arm above shoulder even after 5 days.
This is a spontaneous report from a contactable consumer (patient). A 58-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN6201), at the age of 58, via an unspecified route of administration, in the left arm, on Mar 2, 2021, at 09:30, single dose, for COVID-19 immunisation. Medical history included diabetes and high blood pressure. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient received unknown medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Mar 6, 2021, patient experienced gout symptoms in feet, wrist, elbows and knees. The event resulted in doctor or other healthcare professional office/clinic visit. On Mar 12, 2021, patient underwent rapid test, with result of negative. On Mar 12, 2021, patient underwent PCR test, with result of pending. Therapeutic measures for the event reported as pending. The outcome of gout symptoms in feet, wrist, elbows and knees: not recovered (at the time of this report). No follow-up attempts needed. No further information expected.
Medical history, concurrent conditions and concurrent medications were not specified. The pt reportedly received an injection on Engerix-B (lot ENG2390A2) on 11/25/97, at the age of 8 months. The pt also received DTP vaccine (lot 6F81445) on 4/30/97, (lot 7A81601) on 7/7/97 and (lot 7L81673) on 9/16/97. According to the pt's attorney, he "was born a perfectly normal, healthy boy whose APGAR score at birth was well within the normal range. Developmentally, neurologically and socially, (he) achieved every developmental milestone anticipated of all normally developing children, including the following: a. By 3 months of age, (he) was alert, cooing, responding to sounds, responding to others and beginning to recognize and interact with his parents; b. At 6 months of age, (he) had achieved milestones including speech sounds that form parts of words and was behaviorally responsive to his environment, his parents, other children and toys. c. At 18 months of age, (he) achieved speech milestones, including 3 words strung together in a sentence-type form and had vocabulary of approx. 25 words. At approx. 18 months of age, (he) was neurologically devastated by the accumulation of Mercury in his body, having been exposed via intramuscular vaccinations and suddenly regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to, the following: a. He became withdrawn, unable to speak, unresponsive to his environment; and b. His injuries include the loss of language skills, motor skills and affect." The attorney alleged that these represent "severe devastating permanent neurological injuries". This report of developmental regression is considered "Medically Serious".
This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline). Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant ; manufacturer unspecified given on 9 December 2007; hepatitis A inactivated ; manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as "Flumist" and administered intranasally. There were no other adverse events other than "bad taste."
About a month after the vaccine, I noticed that my arm would hurt with the simple movement like putting on my jacket. I faded but now I have a dull achy. I used Volteran Cream and Aspercream. Neither has helped with the pain. This has been going on for 6 months.
Fast heartbeat within 3 minutes of injection,  slight swelling of face and mouth, weakness, numbness and pain of injection site, red rash on arms and legs, difficulty breathing, losing breath walking short distances, 10 hours later I developed muscle pain all over my body, chills, 102° fever, extreme shaking, difficulty sleeping due to muscle pain/aches, and fatigue.
the day after the vaccine mom reports entire shoulder muscle where vaccine was given was red and swollen. She reports 2 days after is when worse symptoms were noted. He woke up with a red bumpy rash allover his face. His eyes were swollen to the point he could barely open them. Itchy throat and headache. these symptoms have subsided and currently states he is nauseated, fatigue and still mildly swollen in the face.
Pt seen in clinic 2/11/08 w/c/o large erythema, swollen, painful L upper arm. No rash or sob. pt assessed by RN and initially, then scheduled with physician and treated with IV Rocephin 2 grams on 2/11/08 and 2/12/08. On 2/13/08, Cephalexin 500mg tid x10 days prescribed.
Information has been received from a physician concerning a female who on an unspecified dates was vaccinated with the first, second and a third dose of GARDASIL. The patient told physician that a friend experienced a stroke after receiving the third dose of GARDASIL. The friend was admitted to the hospital (intensive care unit) twice and is currently hospitalized. Stroke were considered to be immediately life-threatening. Additional information has been requested.
tenderness to his arm; arm swollen; Cannot even move his arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness to his arm), PERIPHERAL SWELLING (arm swollen) and VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot even move his arm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048821A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced TENDERNESS (tenderness to his arm), PERIPHERAL SWELLING (arm swollen) and VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot even move his arm). At the time of the report, TENDERNESS (tenderness to his arm), PERIPHERAL SWELLING (arm swollen) and VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot even move his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
5/6/2021 - soreness in both feet and ankles - took tylenol this night. 5/7/2021 - woke up in the morning with severe joint pain in knees, ankles and feet. Also had some swelling in lower extremities. She took tylenol and ibuprofen-alternating between the two. Rash started this night as well. Pt was very itchy. Sat - 5/8/2021 - Took Benadryl on Saturday. Sun-5/9/2021 - Rash worsened - continued to use Benadryl. Mon.-5/10/2021 - was seen here at Dermatology office. - two punch biopsies were done. Also given Doxycycline and a steroid ointment to use called clobetasol. A few days later - pt states she started to feel better. Bx result attached.
About 15 mins after receiving flu shot Pt. started having itching and burning  at the injection site (left deltoid). Then a short time later started having itching in her face and down into her throat and started having tightness of breathe. Patient was send to emergency department of this facility. Pt was given Pepcid, Benadryl, and a steroid IV. After treatment patient was returned to work.
Information has been received from an x-ray technician concerning 3 unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 26-OCT-2016, the 3 patients were respectively vaccinated with a dose of improperly stored PEDVAXHIB (lot # M014927, expiration date 18-FEB-2019), dose and route unspecified. The vaccines were stored at 30 F for 9 hours. The date logger was involved in the report. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd 2 doses of Engerix-B & p/2nd dose devel a strip-like lesion under the skin of the lt forearm;
Patient came in for the COVID-19 vaccine booster. When in the clinic the patient received a vaccine dose at 0.3mL undiluted. The correct dose was provided, the wrong concentration was given.
Case number PHEH2014US011023 is an initial spontaneous report from the pharmacist received on 29 May 2014. This report refers to a 22-year-old female patient. She was inadvertently vaccinated with MENVEO (batch number: not reported) via subcutaneous route at a different location on 28 May 2014. On the same date, after vaccination she experienced injection site redness and her injection site raised. The outcome of the events was unknown. The seriousness and causality of the events were not reported.
Red blotchy arm with itching. Pt reports similar reaction with other vaccines. 8mg chlorphenirame given po.
I experienced menstrual irregularity starting the day after my 2nd dose (which is very uncommon for me); those irregular cycles continued for ~2-3 months after my 2nd dose.  Then, after a more normal cycle, I got pregnant (LMP May 13, 2021), had a confirmed intrauterine pregnancy with heartbeat seen on July 2, and then experienced a miscarriage at 10 weeks gestation.  I started bleeding on July 23, 2021, went to an ER (was traveling at the time) on July 24 where an ultrasound showed loss of heartbeat and small for gestational age.  I then miscarried the baby spontaneously the night of July 24/morning July 25.  After traveling back home, I was seen for follow up by Doctor D. (University Hospital) on Aug 6 when I had an ultrasound that confirmed the miscarriage was complete.
Systemic: tooth pain on right, lower jaw-Medium, Additional Details: Patient described tooth pain on the right, lower jaw. She set up an appointment to be seen by her dentist, no updates on outcomes of that visit. Says she could not chew on that side of her mouth without extreme discomfort.
9:00 am shot stung when receiving it.   4:00pm start of body aches,   8:00pm chills and body shaking and headache and temperature of 100.4   headache  and fever continued into next day,
RECEIVED TWO DOSES DUE TO BEING IMMUNOCOMPROMISED; OFF LABEL USE; This spontaneous report received from a patient concerned a female patient of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: kidney transplant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced received two doses due to being immunocompromised, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received two doses due to being immunocompromised and off label use was not reported. This report was non-serious.
This spontaneous report has been received from a nurse and refers to a 14 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with GARDASIL 9 dose 2 series (strength, dose, route of administration, lot # and expiration date were not reported) separated by 1 year and 1 day. No adverse effect were reported. No product quality complaint was involved. Additional information has been requested.
Patients left arm swollen from elbow to mid Tricep area. Patients states the swelling began 5 hours after the injection of the Anthrax.
2 weeks after receiving MMR, symptoms swollen neck gland, red eyes, itching left arm.
Case number PHEH2014US008841 is an initial spontaneous report from the pharmacist received on 30 Apr 2014. This report refers to a 51-year-old female patient. She was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date in Nov 2013. On an unknown date, after vaccination she experienced red, hard lump at the injection site. The injection site was non-tender. The outcome of the event reported as not recovered at the time of the report. The seriousness and causality of the event were not reported.
Severe body aches, fever of 101 degrees for 30 hours.  I guess that isn't much, but it was to me.
Bronchitis resurfaced; Close up of eustacean tubes, throat, and lungs; Close up of eustacean tubes, throat,and lungs; Close up of eustacean tubes, throat,and lungs; Sharp cutting feeling around the heart and deep pressure/ dull pain in my lungs; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162B2 (Pfizer BioNTech Covid-19 mRNA Vaccine) (Batch No: EN6206) via unspecified route of administration on left arm as a single dose for COVID-19 immunization on 06Mar2021 at 13:15.  The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via unspecified route of administration in the left arm on 05Feb2021 at 10:15 for COVID-19 immunisation. The patients medical history included late onset asthma and bronchitis. Prior to vaccination, the patient was not diagnosed with COVID-19. The patients concomitant medications included prescribed medicines and dietary supplements. The patient was allergic to morphine, omeprazole and oxybutynin. The patient experienced close up of eustachian tubes, throat, and lungs all at once 24 hours after receiving second vaccine  and she had sharp cutting feeling around the heart for one hour and deep pressure/ dull pain in her lungs and severe symptoms lasted for one hour on 07Mar2021. The patient also experienced serious Bronchitis resurfaced within 4 days after vaccination on an unspecified date. The patient received treatment for the adverse events albuterol Sulfate Rescue Inhaler. At the time of the report ,the clinical outcome of the events close up of eustachian tubes, throat, chest pain, sharp cutting feeling around the heart and deep pressure/ dull pain were recovering and bronchitis resurfaced was unknown.   No follow-up attempts are needed. No further information is expected.
Patient reported to mother she felt like and elephant was sitting on her chest.  So mother took her to emergancy department. Her throat continued to swell along with her face.
I contracted COVID-19 on 06/14/2022 with symptoms of cough, headache, muscle aches, fatigue, and loss of appetite. I was prescribed an antiviral on 06/16/2022. I was ill for 5 days before my symptoms began to improve. I am still experiencing lingering symptoms of fatigue, and joint pain.
A 16 year old pregnant patient received the first dose of the Moderna Covid-19 Vaccine; A 16 year old patient received the first dose of the Moderna Covid-19 Vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (A 16 year old pregnant patient received the first dose of the Moderna Covid-19 Vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received the first dose of the Moderna Covid-19 Vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy.    On 17-May-2021 at 10:08 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 26-Nov-2020 and the estimated date of delivery was 02-Sep-2021. On 17-May-2021 at 10:08 AM, the patient experienced EXPOSURE DURING PREGNANCY (A 16 year old pregnant patient received the first dose of the Moderna Covid-19 Vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received the first dose of the Moderna Covid-19 Vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 17-May-2021 at 10:08 AM, EXPOSURE DURING PREGNANCY (A 16 year old pregnant patient received the first dose of the Moderna Covid-19 Vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received the first dose of the Moderna Covid-19 Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medication was reported.
BURNING ON THE SOLES OF FEET; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, non alcoholic user, diabeties, high blood pressure, and gastritis, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included metformin for diabetes. On 08-JAN-2021, Laboratory data included: PCR (NR: not provided) Positive. On 15-APR-2021, the subject experienced burning on the soles of feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning on the soles of feet. This report was non-serious.
Almost vasovagal syncope. Vaccine administered at 11:00. Vasovagal symptoms present at 11:03.  Profuse sweating, decreased ability to see (tunnel vision), ringing in the ears (subsequent hearing loss). Fainting did not present, and symptoms completely subsided at 11:08.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Approximately on an unknown date in 2003, the patient was vaccinated with doses 1 and 2, RECOMBIVAX HB (lot #, expiration date and route not reported). The patient was in the office on approximately 29-APR-2013 (reported as now) to receive dose 3, RECOMBIVAX HB (lot#, expiration date and route not reported) which would be late. No symptoms reported. Additional information has been requested.
DIARRHEA; CHILLS; FEVER; This spontaneous report received from a health care professional concerned a 57 year old male. 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: 042A214, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced diarrhea. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and was recovering from fever, and chills. This report was non-serious.
Information has been received from a registered nurse concerning a female child with a history of an egg allergy who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was reported that the patient had an unknown reaction to the measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The patient's status at the time of the report was recovered. No product quality complaint was involved. Additional information has been requested.
BUD 1/7/23, administered 1/12/23 - moderna analysis found lot still active against covid-19 on date given
Significant axillary right swelling (?edema) on side with TDaP and Hep A.  24 hours later and increased over 24 hour noted some shotty axillary adenopathy.
accidently received 2 doses of MENACTRA with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from other health professional (Reference number- 00667570) and transmitted to Sanofi on 02-Jul-2021.  This case involves a 12-years old male patient who received 2 doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (accidental overdose) on 01-Jul-2021 (lot number: U6878BB and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  Concomitant vaccination included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP).  It was a case of an off-label use and accidental overdose (latency same day).  At the time of report, no adverse event was reported.  It was reported that "patient accidently received 2 doses of MENACTRA and asked if there is any documentation regarding any adverse effects or cautions that should be considered. Warm transferred the RN to HCP. Call warm transferred from MIA. Extra Dose SRD sent"  It was unknown if there were lab data/results available.  Disclaimer: 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.