chrisvoncsefalvay/vaers-outcomes huggingface dataset:
three blood clots in right leg; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER2613, Expiry date not reported), via an unspecified route of administration, administered in the left arm on 25Mar2021 15:00 (age at vaccination was 45 years) as single dose for COVID-19 immunization. Medical history included drug hypersensitivity (sulfonamide allergy) from an unknown date and unknown if ongoing, and seasonal allergy from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included fluticasone propionate taken for an unspecified indication, start and stop date were not reported; olopatadine hydrochloride (PATADAY) taken for seasonal allergy, start and stop date were not reported. The patient experienced three blood clots in right leg on 09Apr2021 20:00 with outcome of recovering. Therapeutic measures were taken as a result of three blood clots in right leg (thrombosis) that included blood thinners (Eliquis). The event was reported as serious, medically significant.  No follow-up attempts are possible. No further information is expected.
Per documentation, patient was given flu vax and sibling was given covid vax. On 1/3/23, MOC told PCP she believes patient was given Covid vax and not Flu, as she saw vaccine pulled from the same vial for both siblings on 10/17
Information has been received from a registered nurse concerning a 26 year old male patient who on 29SEP1999 was vaccinated with a dose of varicella virus vaccine live. On 09MAR2004, the patient developed 20-30 pimples on his abdomen and groin. No other symptoms were noted. The patient's mother reported that her son had been exposed to another child with chickenpox last week. It was noted that the child was vaccinated by another HCP. There was no treatment required. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
H1N1 done 1/15 -no symptoms. 1/16 -pt said chills and nose itching. 1/17 -chills /fever 100 degrees F. 1/18 & 1/19 After hrs clinic for right side of face and jaw swollen and later head started swelling. Dr gave steroids. Also developed rash on face. 1/20 -return probs breathing and upper swelling of mouth.
01/05/2021 AT 6PM: BODY ACHES, SEVERE HEADACHES. LOCAL SORENESS, SWELLING
Guillain Barre Syndrome, unknown if connected to vaccine. Developed tingling and numbness in limbs that quickly progressed to loss of reflexes, difficulty standing and walking, and soon also severe pain.  Hospitalized 11/29/21 to 12/6/21. Sudden/severe drop in blood pressure on one occasion. Treated with IVIG. Months of slowly improving difficulty with walking, balance, strength and pain that interfered greatly with school attendance. Primarily used gabapentin for pain outpatient. Completed physical therapy outpatient in March 2022, fully recovered. Put off second dose of Covid vaccine on medical advice, but now planning to get it after further consultation with treating neurologist.
This spontaneous report as received from a health care professional refers to an unspecified number of patients who were vaccinated on unknown dates with unspecified doses of VAQTA that were improperly stored. No adverse effects reported. No further information provided. Additional information has been requested.
Tested positive for COVID-19; had to wait 90 days before receiving another shot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had to wait 90 days before receiving another shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had to wait 90 days before receiving another shot). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had to wait 90 days before receiving another shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
1 of 4 pts who recv Tetramune from the same vial & exp a fever; pt recv vax 13JUL-same evening had a high fever (103-104); no sz; pt recovered;
Severe chills & a fever of 99; took APAP to relieve chills & muscle aches; day of 31OCT90 temp rose to 102.6; low grade fever for 8 days post inject;
Moderna covid vaccine found to be out of date after administration on 8/4/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/4/21) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021 at 7:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/4/21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/4/21) 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 treatment and concomitant medications were provided.
having a sore arm and being tired after the vaccines; having a sore arm and being tired after the vaccines; large cluster of cysts on one ovary in May 2021 large cluster of cysts with a growth on the other side.; This spontaneous case was reported by a consumer and describes the occurrence of OVARIAN CYST (large cluster of cysts on one ovary in May 2021 large cluster of cysts with a growth on the other side.), VACCINATION SITE PAIN (having a sore arm and being tired after the vaccines) and FATIGUE (having a sore arm and being tired after the vaccines) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced OVARIAN CYST (large cluster of cysts on one ovary in May 2021 large cluster of cysts with a growth on the other side.). On an unknown date, the patient experienced VACCINATION SITE PAIN (having a sore arm and being tired after the vaccines) and FATIGUE (having a sore arm and being tired after the vaccines). At the time of the report, OVARIAN CYST (large cluster of cysts on one ovary in May 2021 large cluster of cysts with a growth on the other side.), VACCINATION SITE PAIN (having a sore arm and being tired after the vaccines) and FATIGUE (having a sore arm and being tired after the vaccines) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2020, Scan: normal (normal) showed nothing alarming. In February 2021, Scan: abnormal (abnormal) showed a large cluster of cysts on one ovary. In May 2021, Scan: abnormal (abnormal) showed a large cluster of cysts with a growth on the other side. In October 2021, Scan: abnormal (abnormal) alarming enough for her to be sent to an oncologist..         No Concomitant medications were provided by the reporter. No Treatment Information was provided by the reporter.   This case was linked to MOD-2021-367324 (Patient Link).
This spontaneous report as received from a certified medical assistant and refers to a 4 month old patient of unknown gender. On 13-NOV-2014 the patient was accidentally vaccinated with VARIVAX (Merck) (0.5 ml, subcutaneous, anatomical location, lot number were not reported). No adverse effect reported. Additional information has been requested.
A knot arose on his arm at the injection site.  The shot was administered subcutaneously at a 45 degree angle.  The knot was not red, bruised, or itchy....just raised.  The patient's vitals and respiratory rate were fine.  After 20 minutes of evaluation, the knot appeared a little smaller.
Right arm cellulitis following ADACEL - minor - tx: BIAXIN 500mg 1 POBID X 10d.
had a lot of pain after the first injection; This case was reported by a nurse and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of vaccine and experienced lot of pain. The patient also received 2nd dose and wanted to administered tylenol but immunization coordinator who administered the vaccine told that if she receive tylenol before the pain in her arm  started, the strength of the vaccine would be weakened
I felt very tired for a week after the vaccine, fatigue, I called my doctor and he gave me a medicine to sleep, I felt better, but I am still tired. I took an allergy pill just in case that was part of my problem.
pt recv vax & devel macular type itchy rash that looked like measles & lasted approx 1 mo;
On Sept 26th, had a sudden onset of neurological symptoms.  She experienced blurred vision, speech difficulty, an overall "out of it" feeling, and muscle tics in her head, arms and legs.  We took her to the ER and tests all came back negative.  Her symptoms began to resolve after 6-8 hrs with the exception of her muscle tics which continued.  Over the next couple month, she experienced 2 more mental episodes where her speech and behavior were affected, and the twitching worsened.  Pediatric neurology referral initially diagnosed her with PANDAS but with no active strep infection, possibly PANS related to some other infection.  Repeat blood work did not show any active infection, however.  It was then hypothesized that hte COVID vaccine, which she had received the month prior might have been a trigger to her immune system, and somehow was mimicking the PANDAS symptoms.  At this time, she is still experienced muscle tics, though not as frequently.
Facial and eye Shingles began (4/16/21) three weeks after second shot.  Saw PA of  Dermatology and received Valacyclovir.  Saw Dr. OD and received Prednisolone. Saw  of  Wellness Center and received more Valacyclovir.
Left thumb became  numb and painful 5 minutes after injection, then after 15 minutes it spread to my entire hand. Also tingling  in my entire arm and pain in my shoulder.  Today,  my thumb is improved, but all my fingers are still tingling, painful and somewhat numb.
Seizure, administered patient's own diazepam once able to swallow, husband was familiar with how to care for wife when she has seizures. Aprox 15 min after seizure onset, patient walked with husband to car to go home.
5/2/18 P.M. soreness at injection site - hurt more than usual in evening - nothing visible - hurt to move his arms to brush his teeth next morning. 9:30A 5/3/18 hurt across his chest - trouble breathing. 11:10Am in ribs 1:30-2PM - water play day - hurting even more - hurt entire body. Restless at home.
Sx began approx 6 days p/vax c/o low grade fever, muscle aches, pain across upper abd., joint pain  w/o swelling & nausea; sx subsided & then reocurred 5JUL91; Seen by MD on 7JUL91; Sx reoccured on 15JUL91;
pt recv vax;leg looked like it was baked per mom;amb called for poss CPR arrived CPR in progress;mom woke up found pt under the pillow, unresponsive;pupils fixed dilated, skin warm w/cyanosis;pt lifeless @ home dx unexplained death of pt
Atrial fibrillation; right arm pain (injection site); Joint pain; This is a spontaneous report from a contactable consumer (patient), received via the Pfizer sponsored program. A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 26Jul2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation.  Medical history included Shingles shot (a year ago which had nothing to do with COVID and had Shingles shot months and months before that), allergy to perfumes, cats, dogs, sulfates and penicillin, hip replacement and reaction to titanium which caused chromium and cobalt to build up in her system and had build up of calcium in her right leg in the muscle and in the hip. The patient's concomitant medications were not reported. The patient experienced atrial fibrillation, right arm pain and joint pain. The event atrial fibrillation was treated with blood thinner. Patient reported also that she was due to get her second dose, but she will be having a planned Colonoscopy the day after, and she will also be stopping her blood thinner 3 days before her Colonoscopy per protocol. The outcome of events was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Very sore right shoulder. Tired. Achy. Loss of appetite. Slight headache.
Information has been received from a certified medical assistant, via a company representative, concerning a female patient (age not reported), who on an unknown date was vaccinated with a dose of GARDASIL (lot # not reported). Immediately following the vaccination, the patient fainted. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Shortly after receiving vax, the pt experienced blurred vision in left eye. Later complained of fatigue and lymph involvement.
Breakthrough case admission after 4 vaccines  Pfizer 5/24/21 lot# Ew0191; Pfizer 6/14/21 lot# Ew0217;  Pfizer 1/9/22 lot# FL3209;  Pfizer 9/30/22 lot# GH9703
No additional AE; Caller reported TE for VARIVAX that was administered to one patient. TE Filed. No symptoms reported. No consent to contact HCP, caller stated that they were instructed by their supervisor to not contact patient's HCP until the TE wa; This spontaneous report was received from a pharmacy technician an refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-JUN-2023, the patient was vaccinated with an improperly storage varicella virus vaccine live (OKA/MERCK) (VARIVAX) 0.5 milliliter, lot #W022605, expiration date: 17-JUL-2024, administered for prophylaxis (frequency, strength, anatomical location, and route of administration were not provided); which was diluted with sterile diluent (dose, frequency, strength, lot #, expiry date, and route of administration were not provided). Temperature excursion occurred at -13.9 C for 25 minutes and 13 seconds. No prior temperature excursion was reported. No symptoms were reported. No additional information or adverse events were reported.
Fever to 104 and generalized febrile seizure approx 4 hrs following tetramune. No sequelae seen. Rx with Tylenol.
Flare ups due to vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Flare ups due to vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Flare ups due to vaccine). At the time of the report, VACCINATION COMPLICATION (Flare ups due to vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment information was provided by the reporter.
Headache, Myalgia & Fever  Narrative:  Patient received 2nd dose of vaccine on 3/10/21 and began  experiencing symptoms within one hour of receipt. Reported symptoms included  injection site pain/discomfort, fever, chills, headaches, and body aches. Reports  using Tylenol for symptom relief (unknown dose/frequency). Fully resolved as of  date of report.   Other Relevant History:
Within 24 hours: Fever over 100°F, chills, vomiting (possibly with blood), coughing, runny nose, body aches, fatigue, menstrual cramping and discharge, dizziness, migraine After 36 hours until now (68 hours later): Shortness of breath, fatigue, body aches, migraine, severe menstrual cramping and discharge, dizziness, coughing
This case was reported by a healthcare professional and described the occurrence of drop in platelet level in a teenager female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). In approximately 2002, the subject received unspecified dose of Hepatitis B vaccine (unknown). In 2002, two weeks after vaccination with Hepatitis B vaccine, the subject experienced drop in platelet level, hair loss, lupus-like reaction, possible lupus and vaccine reaction. The reporting healthcare professional stated that a subject previously received a hepatitis B vaccine 10 years ago (was unsure of the brand), two weeks after receiving the vaccine the subject experienced hair loss and platelets dropped. It was reported that "back then physicians were unsure if the subject had lupus type reaction or if this was due to the vaccine". The "hair loss may have been lupus or some delayed reaction to vaccination". The healthcare professional was inquiring about what the difference was between ENGERIX B and HAVRIX since the subject was to received a hepatitis A vaccine, the subject was instructed not to received another hepatitis B vaccine; the subject is currently 26-years old. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the drop in platelet level, hair loss, lupus-like reaction, possible lupus and vaccine reaction was unspecified. The vaccination course with Hepatitis B vaccine was discontinued.
I began having noticeable moderate tinnitus mostly in my right ear with very little in the left and pressure at my jaw pint below the ear and deep in the inner ear. It has been continuous since the 4th day after my second Pfizer dose. I?ll be seeing an ENT as soon as possible. It?s been very anxiety inducing as I have never experienced tinnitus in my life before and never had in prior ear or allergy conditions in my life to have correlated with this.
Vitals dropped and lost consciousness about 5 minutes after injection. I wasn't anxious nor dehydrated. Afterwards I couldn't sleep because of a racing heart rate when I returned home after about an hour. Heard rate stabilized and I was able to nap after another hour. I had a serious brain fog, vertigo, dizziness, wandering eyes (can't focus them, going cross-eyed a lot), memory loss (unsure if I completed a task or not), and faint hearing (this improved on day 2). I'm currently on day 3 and I am trending upward but not 100% yet.
Hives for 5 days treated with diphenhydramine oral OTC 2 tablets daily for 4 days.
hearing loss; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a health care provider for hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event hearing loss was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, hearing loss was determined to be medically significant.
Tingly pains in left hip with weakness and nausea - developed rash on left side of back that radiates to hip. Received ZOSTAVAX on Tues - 5/5/09. Sx started on 5/7/09.
Information regarding PREVNAR was received from a healthcare professional regarding a 3-year-old male patient who experienced 40% of right lateral thigh was red and swollen.  At 3 years of age, the patient received the fourth dose on 08-Mar-2006.  Relevant medical history was not provided.  Product was administered on 08-Mar-2006.  Concomitant therapy included Hep A.  On 08-Mar-2006 40% of the patient's right lateral thigh became red and swollen after he received his 4th dose of PREVNAR.  The patient recovered without treatment.  No additional information was available at the time of this report.
The day after my second injection I developed a  non itchy rash on my chest and arms.  I also had fever and chills the first two days and fatigue.
Upper respiratory infection; This case was reported by a consumer via interactive digital media and described the occurrence of respiratory infection in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, several days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced respiratory infection (serious criteria GSK medically significant). On an unknown date, the outcome of the respiratory infection was unknown.   It was unknown if the reporter considered the respiratory infection to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient experienced an upper respiratory infection days after receiving the Flu vaccine, just like clockwork. It was reported that, the doctors said same thing it was a coincidence. The reporter felt that the doctors were lying through their teeth. As far as the whooping cough was concerned, the people were being injected then shedding the vaccine. It was reported that, if the reporter was obviously coughing and knew was sick, I would not be around a baby, or an elderly person. It was reported that, when you were vaccinated, there may be no symptoms, until had been already infected by another person. This is 1 of the 3 cases reported by the same reporter.