chrisvoncsefalvay/vaers-outcomes huggingface dataset:
neurological issues; left side of face numb/numbness and tingling in forearms/numbness and tingling in bottom of legs under knees/numbness and tingling in scalp/numbness and tingling sometimes in face; left side of face tingly/tingling in head/numbness and tingling in forearms/numbness and tingling in bottom of legs under knees/numbness and tingling in scalp/numbness and tingling sometimes in face; tingling in head; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of NERVOUS SYSTEM DISORDER (neurological issues), HYPOAESTHESIA (left side of face numb/numbness and tingling in forearms/numbness and tingling in bottom of legs under knees/numbness and tingling in scalp/numbness and tingling sometimes in face), PARAESTHESIA (left side of face tingly/tingling in head/numbness and tingling in forearms/numbness and tingling in bottom of legs under knees/numbness and tingling in scalp/numbness and tingling sometimes in face) and HYPOAESTHESIA (tingling in head) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced NERVOUS SYSTEM DISORDER (neurological issues), HYPOAESTHESIA (left side of face numb/numbness and tingling in forearms/numbness and tingling in bottom of legs under knees/numbness and tingling in scalp/numbness and tingling sometimes in face), PARAESTHESIA (left side of face tingly/tingling in head/numbness and tingling in forearms/numbness and tingling in bottom of legs under knees/numbness and tingling in scalp/numbness and tingling sometimes in face) and HYPOAESTHESIA (tingling in head). At the time of the report, NERVOUS SYSTEM DISORDER (neurological issues), HYPOAESTHESIA (left side of face numb/numbness and tingling in forearms/numbness and tingling in bottom of legs under knees/numbness and tingling in scalp/numbness and tingling sometimes in face), PARAESTHESIA (left side of face tingly/tingling in head/numbness and tingling in forearms/numbness and tingling in bottom of legs under knees/numbness and tingling in scalp/numbness and tingling sometimes in face) and HYPOAESTHESIA (tingling in head) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication included. Treatment medications included steroids and antibiotics.
I had a very sore arm at the injection site which I  knew was to be expected that began the day after the vaccine on Sunday, August 15.  On Wednesday August 18th I noted my axillary lymph nodes were swollen.  I felt achey, tired, shakey and with a slight headache on Thursday and Friday, the 19th and 20th.  Late afternoon on the 20th , my arm began to itch and I noticed a red, raised urticarial rash around the injection site measuring 5.5 x 3 inches.  I took OTC Zyrtec and the hives resolved however the raised, erythematous rash persisted.  It was not painful but continued to itch.  On Tuesday morning approximately 5:00 am I awoke with urticaria around my eyes, lower forehead, nasal bridge and behind my ears.  I did not have any breathing problems or swallowing difficulty.
Almost immediate (2-4 hrs.) swelling & pain at injection site - c/o myalgias & swelling, heat & redness entire R upper arm.
Three days after my 2nd shot of Maderna I started experiencing skin sensitivity on my right arm.  This continued to get worse and 2 days later I was getting pain in the arm.  3 days later I noticed a rash and some pimples.  That is when I went to the urgent care. At that point I was told most likely it was the Shingles and that I caught it early. I was given Valacyclovir to take for 7 days. The following day the pimples turned in blisters and were very itchy.  Also, the pain in my arm at night at times was almost unbearable. I was on advil to help this. A week after starting the Valacyclovir I was feeling better during the day. Sleeping was still difficult since the pain seem to come after I laid down. Again. I needed to take advil on a schedule to be able to get some rest. As of today, 4/10/21, everything is drying up. Because of the intense pain in my arm, I still need to take the advil at bedtime.
Mother called clinic at 5:15 pm  7/8/08 stating child had temp 101F this am. She has given Motrin and Tylenol and now at 5:15 Pt temp 101.2 even though Tylenol brought tempt down this am, told to cont. Tylenol Motrin, spoke to mother 7/10/2008 she stated temp completely resolved by 7/9/08 and child has no problems.
30 minutes after receiving Pfizer COVID vaccine #1 pt reports he became very flushed and hot and fatigued. Itching started later that night. Face felt swollen but no difficulty breathing, swallowing. I saw him the following day via telehealth and he reported generalized redness was improving but not resolved and pruritis persisted but was improving but the hour.
Aggresive hives; No swollen lip or very small swollen but "aggresive hives"; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Aggresive hives) and LIP SWELLING (No swollen lip or very small swollen but "aggresive hives") in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 044AZ21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced URTICARIA (Aggresive hives) and LIP SWELLING (No swollen lip or very small swollen but "aggresive hives"). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) ongoing since an unknown date for Hives, at a dose of UNK, bid and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) ongoing since an unknown date for Lip swelling, at a dose of UNK, bid. At the time of the report, URTICARIA (Aggresive hives) had not resolved and LIP SWELLING (No swollen lip or very small swollen but "aggresive hives") was resolving.            Patient had taken a muscle relaxer on 5/17/2021 and woke up full of hives.   This case was linked to MOD-2021-073809 (Patient Link).
Local reaction: about a 4"red area with little red blotches toward the armpit area. Pt states that it showed up the next day, and has remained the same. Pt reports that it has not gotten bigger. Pt reports no other symptoms. The site is warm to the touch and red only.
This spontaneous report was received from a health care professional refers to an unspecified number of patients of unknown demographics. On an unknown date the patients were vaccinated with improperly stored GARDASIL injection, lot # K010215; expiry: 05-MAY-2017 (dose, route and frequency unspecified). No concomitant medications were reported. No symptoms reported. No further information provided. Additional information has been requested.
Mom called nurse advice line on 11/12/13 because child had "twitching yesterday," c/o "some eye rolling today." Examined by Dr. on 11/12/13. Chart note states child was fussy through night, awoke screaming, then limp, eyes rolled back, pale, (R) leg shake x 10 sec. Nomal within 30 minutes.
No additional AE reported; VARIVAX was administered during a T/E; This spontaneous report was received from a nurse, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 16-OCT-2023, the patient was vaccinated with an improperly stored dose of with improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, for prophylaxis (lot number: X010525, which has been verified to be valid, expiration date reported and validated as 11-APR-2025) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported).   Administered dose was stored at a temperature of 12.5 degrees degrees Fahrenheit (F), during a time frame of 25 minutes (product storage error).   No additional adverse events were reported in the patient.
Fever (100.4), chills, violent muscle shaking for 2 hours, severe headache. Duration of event was seven hours but headache continued for another 8 hours.
3 days after dose 1, which was given on 05/28/21, PT reported feeling not herself. She was experiencing brain fog and not able to focus on her school work. She was worried about not being able to finish up the school year. We figured it was just "burnout", but knew this was strange behavior for PT who is usually very focused and has no problem getting good grades. We let her get the 2nd vaccine on June 18th. About 10 days later, PT reported feeling like her mind was racing and she could not sleep for 5 nights. She was very anxious and having panic attacks. On July 4th, PT came to us and told us, "the only way to stop the thoughts is to hurt myself." We immediately took PT to the  Hospital ER. We have NEVER seen PT like this and she has NEVER had thoughts like this. She was talking to herself, making strange body movements and this frightening behavior came out of nowhere. They kept her overnight and sent her home with referrals to other doctors. She is still having suicidal thoughts and cannot function. We have had to cancel all trips, summer camps and check her out of soccer for the next month. There is no way she is going to be able to go to anything.
8 year old female with pre-existing neurological issue became weak and unable to walk after the first dose of the 5-11 Orange cap dose; 8 year old female with pre-existing neurological issue became weak and unable to walk after the first dose of the 5-11 Orange cap dose; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An 8-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Underlying neurological disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), GAIT DISTURBANCE (non-serious), outcome "unknown" and all described as "8 year old female with pre-existing neurological issue became weak and unable to walk after the first dose of the 5-11 Orange cap dose". The events "8 year old female with pre-existing neurological issue became weak and unable to walk after the first dose of the 5-11 orange cap dose" required emergency room visit.  Additional information: Comirnaty/Pfizer BioNTech Covid-19 vaccine /Orange cap 10 mcg. She was sent to the emergency room immediately (the adverse event occurred within 15 minutes of the vaccination). Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Mom reports child received shots 8/16/02. On 8/17/02 child's arm was red and swollen from approx. 1" above elbow to top of left arm. Top of arm was oozing and crusty. Checked by MD, who told mom to call HD and report. Swelling gone by 8/20/02.
4 months old received kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a pharmacy student. The reporter reported that a 4 months old patient received a Kinrix dose, which led to inappropriate age at vaccine administration. Consented to follow up was provided. .
Case number PHEH2013US014196, is an initial spontaneous report received from a nurse on 27 Jun 2013. This case refers to an 11-year-old male patient. His medical history and concomitant medication were not provided. He was vaccinated with MENVEO, batch number: M12118 and expiry date: Aug 2014), at a dose of 0.5 ml intramuscularly on 20 Jun 2013. Reporter stated that, MENVEO vaccine was stored at 4.6 F for 4 hours on 20 Jun 2013 and does not know if vaccine was frozen. No adverse event was reported following this administration error.
High blood pressure  I  work out often and always watched diet. I have been having constant migraine headaches,  also my nerves seem to be heightened
Pt received vaccine in (R) GM. The next day she had swollen inguinal lymph nodes on the right. Temp of 101, wheezing and extreme pain in the groin and down the right leg. Pt now afebrile but has swollen hands with pain.
Previously healthy, received 1st set of immunizations.  That evening during bath, turned pale white, not acting right for few hours, went to ER and admitted to hospital.    5/16/08 Reviewed hospital medical records of 2/28-2/29/208. FINAL DX: apparent life threatening event Records reveal patient experienced pallor & 'not acting right' for a few hours after vaccinations.  Temp 100.4 in ER.  Admitted to be monitored overnight.  No further episodes & d/c to home.
4/16/2021-sore arm and slight swelling at 5:00 PM.                                     4/17/2021-fatigue, slight headache, elevated temp at 4:30 AM; severe headache and fatigue at 11:00 AM; took two 500 mg acetaminophen talents at 11:00 AM;  fell asleep at 1:00 PM and woke up at 2:00 PM with less head pain; 5:00 PM severe headache again and nausea;  took two 500 mg acetaminophen tablets at 5:00 PM.  Felt better by 9:30 PM-slight headache, slight nausea:  4/18/2021-no headache, normal temp, no nausea
good size lump at injectin site; quarter size red patch at injection site,  red patch at injection site reappeared; can't lift her left arm past halfway bc it hurts too bad; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (good size lump at injectin site), INJECTION SITE ERYTHEMA (quarter size red patch at injection site,  red patch at injection site reappeared) and MYALGIA (can't lift her left arm past halfway bc it hurts too bad) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced INJECTION SITE MASS (good size lump at injectin site), INJECTION SITE ERYTHEMA (quarter size red patch at injection site,  red patch at injection site reappeared) and MYALGIA (can't lift her left arm past halfway bc it hurts too bad). At the time of the report, INJECTION SITE MASS (good size lump at injectin site), INJECTION SITE ERYTHEMA (quarter size red patch at injection site,  red patch at injection site reappeared) and MYALGIA (can't lift her left arm past halfway bc it hurts too bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
G47.33 OBSTRUCTIVE SLEEP APNEA 4/23/2023 COVID-19 DISEASE G47.33 OBSTRUCTIVE SLEEP APNEA 4/23/2023 MALAISE G47.33 OBSTRUCTIVE SLEEP APNEA 4/23/2023 ESRD (END STAGE RENAL DISEASE) G47.33 OBSTRUCTIVE SLEEP APNEA 4/23/2023 UPPER GI HEMORRHAGE
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot#, expiration date, dose and route unspecified). Other suspect and concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician and an office manager concerning a 6 month old patient who on approximately 29-OCT-2007 was vaccinated PO with a fourth dose of Rotateq (no lot number was provided) in place of PREVNAR.  Concomitant vaccinations administered on that same day included a dose of Varivax (MSD), MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (MSD) and a dose of of FLUZONE.  Subsequently the patient developed a viral rash which had since resolved.  It was unknown whether medical attention was sought.  It was noted that the patient had already received Rotateq at 2 months, 4 months and 6 months.  There was no product quality complaint.  Additional information has been requested. 02/11/2010 Follow-up information has been received from a physician concerning a 12 month old male with no pre-existing conditions or drug allergies who on 29-OCT-2007 at 14:00 was vaccinated PO with a fourth dose of GARDASIL (lot# 09024). There was no illness at the time of vaccination. Concomitant vaccinations administered that same day at 14:00 included the first SC does of VARIVAX (lot# 659159/1369U) in the left thigh, the first SC dose of MMR II (lot# 657344/0527U) in the left thigh, the fourth IM dose PREVENAR (lot# 370143D) in the right thigh. No labs or dianostic studies were performed. Subsequently the patient recovered.  Additional information has been requested.
L upper deltoid with 100 cm of erythema, swelling & warmth  zero damage + tender noted next day really increase later that night.
anaphylactic shock; difficulty breathing; coughing; This is a spontaneous report from a non-contactable consumer (parent). A 4-decade-year old female patient received Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylactic shock, difficulty breathing, coughing all on an unspecified date. Caller is a father. He states that he has a mid 30s year old daughter that he describes as morbidly obese. He states that she declines to receive the COVID 19 vaccine because she says there is PEG in the vaccine and that she is allergic to it. He relays that they would really like her to get it because she could get really sick or pass it to someone else, he states that she has kids or that she could pass it to them (referencing himself). He states that she was coughing and having some symptoms 7-8 years ago and so she received a pneumonia vaccine. She had a reaction that resulted in difficulty breathing and he describes as anaphylactic shock. He states that the doctors at the time said that it may have been to the PEG in the pneumonia vaccine but that they were not sure. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Went to physician with vesicular rash on upper trunk. <50. Dr treated pt. with acyclovir.
Patient experienced dizziness and high blood pressure the day after her vaccine. Bloodwork, per patient, showed normal.
pt recvd vax; unconscious, total body jerking, apnea lasted 20-30 secs; syncopal episode; dph elixir given;
Chills  24 hrs after vaccine.  Sporadic during day for up to 48 hrs. Total body rash noticed 36 hrs after vaccine, no raised areas or itching..  No difficulty breathing.   Cetirizine HCL 10mg no change in rash after 1 hr.
4 days of hypoglycemia - shakiness and ravenous to try to neutralize the shakiness
pain after the first dose/ left arm is the affected arm; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route in the arm on an unspecified date as a single dose for covid-19 immunization. Medical history included illness. The patient concomitant medications were not reported. On an unknown date, patient experienced pain after the first dose/ left arm is the affected arm. The clinical outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
HEARING LOSS; HEARING PROBLEM/MAKES IT HARD TO HEAR; DIZZINESS; TINNITUS/TOSSING IN MY EARS/PULSING IN EAR; FEVER; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: patient did not have any health conditions. Patient was not pregnant nor breastfeeding at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 10-MAR-2021 to left arm as prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, after the vaccine administration, patient experienced fever for a day, then it went away and she was doing ok. Laboratory data included: Body temperature (NR: not provided) 104 F. On 15-JUN-2021, (in the middle of June), patient started experiencing hearing problem. Patient experienced hearing loss, tossing in ears, made it hard to hear, tinnitus, not for all day but mostly when she woke up. Symptoms were getting worse, pulsing in their ears but not all day, made it very hard to do things, could not hear very well, dizziness. Patient did not perform any lab test, investigation, or diagnosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 11-MAR-2021, and had not recovered from dizziness, hearing problem/makes it hard to hear, tinnitus/tossing in my ears/pulsing in ear, and hearing loss. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210835136.; Sender's Comments: V0: 20210835348-Covid-19 vaccine ad26.cov2.s-Hearing loss. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).