chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient woke up in the night with tongue, lips, hands, feet swollen. Skin red all over. Itching all over body. Patient went to the ER. Was given epi shot. At ER approximately 11:30pm on 10/19/2022
Pancreas issues; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient's wife) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE. Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was in the hospital with pancreas issues. The patient's wife said that it was not because of vaccine that the patient was hospitalized after first dose. The patient missed the second vaccine dated 19Mar2021 and the patient's wife wanted to know if this will be at a certain location again. The outcome of the event was unknown. The event was assessed as unrelated to the suspect vaccine.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Reported event pancreatic issues is considered intercurrent and unrelated to BNT182B2.
The patient's mother states the patient complained of pain in her arm. The next day the patient's arm was red, swelling and feeling hot. The patient was treated with Motrin and Augmentin. A small nodule persists in the left deltoid area.
Injection site became sore shortly after injection was given and has remained sore (22 days).
HIVES 48 HOURS AFTER INJECTION. RECEIVED SOLUMEDROL 250 MG IM X 1 IN OFFICE.
C/O rapid heart beat and lightheadedness.  EMT notified.  VS:  Resp 26 on room air, Oxygen Sat 100%,  pulse 186, and B/P 121/97 @ 6:03pm.  6:05pm = BP 162/91, pulse 107.  Client refused transfer to hospital.  Client advised to follow up with PCP.
In Aug 13th, patient received her HPV vaccine. 1 month later (Sept 13th)  Started with HA fatigue, stomach pain, sore throat ear pain, runny nose, no fevers. Tested for strep and was negative.  Symptoms lasted 5 days. She would come home from school, and then go right to bed for about and hour and then get up. Do her schoolwork. She continued to have some lingering fatigue. Was able to go on trip, after 3rd day of the trip she was dragging quite a bit, wanted to go back to the room.  October 3rd, developed another sore throat and belly pain. Throat Cx and CBC were normal. TSH 5. FT4 1.08 nml. Continued to have stomach and HA ear pain, lasting another couple weeks. Went back to the doctor Oct 5th. Tested for EBV and Lyme which were neg. Strep negative again. Seen by ENT, no sinus disease. October 6th she started having difficulty walking stating that the room was spinning. Developed slow movements. She didn't want to eat or drink. Continued to complain of sore throat.     Pediatrician did prescribe doxycycline for a course which did not effect symptoms. Treated with singulair and Benedryl started to improve some. She started to need to be helped up the stairs. On Oct 14th she had very difficult time getting to stand which they attributed to weakness. She was really saying why she couldn't get up. Says she felt like the room was spinning (worse with eyes closed and with turning of her head) and that her legs were very heavy. No nausea or vomiting. Seemed lethargic. Admitted to the hospital. MRI of the brain and the spine were normal. She was having difficulty standing. For the first few days of admission worked with the psychologist. She then continued to have substantial HA, abdominal pain, anorexia, extreme fatigue, dizziness. She did have an episode when she came out the shower, she seemed pale and looked like she was going to pass out. Started IVF's after that. Following this she seemed to walk a little better. Had an EMG, EEG, LP which were all normal. Overall seemed to be slowly improving was able to walk with PT and walk up stairs. Since she got home, she is eating better. Dizziness is worse in the evening. In the morning she seems to have better energy level. Now HA once every other day last 10 min -60 min back of the head. No N/V/D.  Belly pain waxes and wanes, about every other day. Fatigue is slowly improving but waxes and wanes. Out of school arranging for home school. Overall functionality: at its worse 2/10, currently 4/10.
This is a spontaneous report received from a consumer or other non-HCP (patient). A 36-year-old female patient (not pregnant) received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# EP6955), at the age of 36, in left arm, on Mar 25, 2021, at  12:30, single dose, for COVID-19 immunisation. Medical history included intracranial hypertension (unspecified if ongoing); and asthma (unspecified if ongoing). Concomitant medication(s) included: Acetazolamide and Zyrtec (cetirizine hydrochloride). Vaccination history included the 1st dose of BNT162B2 (Comirnaty), at the age of 36, in left arm, on Mar 2, 2021, single dose, for COVID-19 immunization. The patient experienced  pain in extremity/sore arm and mild fatigue, onset Mar 25, 2021, at 21:00, with outcome of recovering. No therapeutic measures taken as a result of pain in extremity or fatigue. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19  vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. No follow-up attempts possible. No further information expected.
Information has been received from a registered nurse concerning a 19 year old female for GARDASIL, a pregnancy registry product, who on 24-SEP-2008 was vaccinated with a first dose of GARDASIL. The patient received a second dose of GARDASIL, and a third dose of GARDASIL (lot # 662300/0100Y). The nurse did not have a lot number for the first and the second dose. The patient became pregnant after the third dose of GARDASIL. The patient's last menstrual period was on 03-JUL-2009 and her estimated delivery date will be on 09-APR-2010. No adverse reactions reported. The patient sought medical attention through a phone call to the health department. Follow up information received from a registered nurse indicated that the patient was a female with asthma, hypothyroidism and a previous live birth; it was also reported that the patient smokes 10 cigarettes a day not drink alcohol. Concomitant therapy included a second dose of hepatitis A virus vaccine (unspecified) (manufacturer unknown), SYNTHROID, prenatal vitamins, albuterol and ADVAIR. In December 2009 the patient had a normal ultrasound. In February 2010 the patient developed pneumonia, the was treated with antibiotics, the patient was not hospitalized because of the pneumonia. The pneumonia's outcome was unknown. On 18-APR-2010 at 41 weeks from her last menstrual period the patient gave birth to a normal female with no congenital anomalies, who weighed 8 pounds and 2 ounces. The baby's length was 20, *25. No further information is available.
Vaccine was administered to patient after lunch at 2:00 pm. Patient just had Coffee, Red Velvet Loaf and Sausage Croissant. About 1 &1/2 hours later she was feeling light headed and dizzy.  She was check out by the nurse at the Clinic and she was having syncope. Nurse had her legs up and she started feeling better. Around 4:00pm she came back to the pharmacy and was sitting in counseling room and started feeling worse and later started seizing. Ambulance was called and patient was taken to the hospital.
Tested positive for COVID-19; Tested positive for COVID-19; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4265408-00 (Abbvie).  A 47 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Dec2021 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Lot number: 1155128) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken for upadacitinib was unknown.  Clinical Information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of the events with the suspect product was provided as possible at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events
Pt came in with parent during max vax on 2/10/22.  MA ordered and gave JJ, which is for 18yrs and older. MAs reports constant confusion with guidelines changes and being overwhelm with doing both documenting and administering  vaccination in the room.  MA educated on vaccines and ages for each. I will continue to go over vaccines and guidelines--- as well as printing the sheet and provide one to each room. Also continue to reiterate to check doses and vaccine when picking them up from MA station and when documenting in the computer. Moving forward to try and prevent this from happening again MAs will write down on top of questionnaire form "vaccine age appropriate" with initials----confirming that the right vaccine/dose will be given.  Pt was notify of event.
dead arm; arm pain; This is a spontaneous report from a non-contactable consumer reported for himself. A 39-year-old male patient received bnt162b2, via an unspecified route of administration on 22Jan2021 at 05:00 PM in the right arm (dose: 01) at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 at 08:00 PM, the patient had dead arm and patient thought they were exaggerating the extent of the arm pain and thought he was obligated to report. Patient did not receive treatment for the adverse events. The outcome of the events was unknown.   No follow up attempts are possible. Information about lot/batch number cannot be obtained
The patient experienced pain and redness at Td injection site; also reported chills and possible fever (temp. not taken); TYLENOL was taken. The following day the patient returned to the health center for urgent care - the injection site was swollen, red hardened and warm to touch (no fever); patient also complained of pain. Cold packs were applied to the injection site.
Twitching in left thumb one day following influenza injection.  Parasthesia left foot, progressing to right foot and bilat hands.  Twitching of various body parts.  Banding discomfort and nerve pain in extremities.  Shakiness, nervousness, night sweats, nausea, neck and back discomfort, lip tingling, exhaustion.  Symptoms ongoing since 11/2/2007.  Seeing various doctors/specialties including neuro, ID, Rheum.  02/25/2008 Lengthy neurology and endocrinology consults received dated 1/25/08 and 2/12/2008 respectively with no definative DX provided. Pt reported twitching of the L thumb, tingling of both feet, extreme fatigue, upper back pain, neck pain, shoulder blade pain, LBP, flank pain, calf pain, cramping of the foot, limb heaviness,  weakness, muscle twitching, night sweats and formication.  PE (+) for minimal ankle edema, 3+ DTRs at the patellae otherwise WNL. No Dx made at this time by neuro. Endocrine consult for mildly elevated Cacium levels with no clear Dx.  Plan to follow over time.
Information has been received from a registered nurse concerning a 16 year old female with no pertinent medical history who on 16-JUL-2007 was vaccinated with a 0.5 ml first dose of Gardasil (Lot #658094/0524U).  There was no concomitant medication.  On 16-JUL-2007 the patient almost fainted.  The patient went home and later that evening, the patient experienced abdominal pain that lasted for one hour.  The patient also experienced This is in follow-up to report(s) previously submitted on 10/12/2007.  Initial and follow-up information has been received from a registered nurse concerning a 16 year old non smoking female with sinusitis and a cough (for 4 weeks) being treated with AUGMENTIN at the time of vaccination  who on 15-JUL-2003 at 6:30 pm was vaccinated intramuscularly into the right upper arm with a 0.5 ml first dose of GARDASIL (Lot #658094/0524U).  On the same day at 6:30 pm, the patient was vaccinated intramuscularly into the left upper arm with a first dose of MENACTRA (Lot #02366A).  On 16-JUL-2007 the patient almost fainted.  The patient's mom called the office and reported that the patient had a reaction to GARDASIL.  At 10:00 pm on the night of vaccination the patient doubled over crying with stomach pain.  She complained of feeling her heart race at the same time.  Teh mother stated that the patient reported her heart felt like it was racing only during the time she was crying (approximately 15-20 minutes) By the time they arrived to the emergency room (ER) the patient had calmed down and the heart rate felt normal.  The patient complained of feeling dizzy and nauseated in the ER.  The abdominal discomfort lasted approximately one hour and then was completely gone.  The mother reported that the ER did nothing except monitor the patient for the short time.  Her blood pressure was 114/64, pulse was 66, pulse oxygenation was 98 percent, respiration was 22 and temperature was 35. 4 celcius.  On 16-JUL-2007, the patient  recovered and was sent her home.  Additional information has been requested.
Stiff neck after sever weeks; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck after sever weeks) 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 MUSCULOSKELETAL STIFFNESS (Stiff neck after sever weeks). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck after sever weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
Sick; Initial information received on 12-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced sick after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for flu (Influenza immunisation).  On an unknown date the patient developed a non-serious sick (illness) (unknown latency) following the administration of influenza vaccine. It was reported Happened to me Sick 1 week.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: recovered on an unknown date for the event sick.
Red welts on upper part of legs, itch, time approx 10am, given a shot of Benadryl.
Soreness at injection site following administration of PPSV23 onset same day, improved next day. PPSV23 dose was given per age 65yo, was later discovered pt had already received PPSV23 on 1/6/22.
Pt claims arm became sore after administration. It is now difficult for her to lift her arm up or move it in a circle. Nearly 3 weeks have passed and she is still very sore.
no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 48-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    Concomitant medications were not reported.  Total 26 doses from Lot 065K21A Monovalent doses were administered after the BUD to patients. Treatment medications were not reported.
Itchiness on their arms; Redness on their arms; Bumpyness/bumpiness on their arms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness on their arms), ERYTHEMA (Redness on their arms) and SWELLING (Bumpyness/bumpiness on their arms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchiness on their arms), ERYTHEMA (Redness on their arms) and SWELLING (Bumpyness/bumpiness on their arms). At the time of the report, PRURITUS (Itchiness on their arms), ERYTHEMA (Redness on their arms) and SWELLING (Bumpyness/bumpiness on their arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Upon waking up a red dot the size of a dime appeared. Was hot and there was round raised bump underneath. By 3pm the size had spread to about 1 inch in diameter with increased temperature. On 6/6 it had expanded 1/2 inch upon waking. By 3pm it had expanded another 1/4". Going in for a follow up my doctor looked at the arm and indicated that it was infected and prescribed antibiotics.
Vaccines given 6-5-08.  Fever 101.8 10:00 pm, seen in ER.  Labs drawn.  Sent home.  Seen here (in office) morning 6-6-08 with fever 102.1 and then admitted to hospital for observation and further evaluation.  Symptoms - fever and irritability.  8/5/08 Reviewed hospital records of 6/6/08. FINAL DX: viral exanthem or fever, secondary to immunizations Records reveal patient experienced fever & irritability later on day of vaccinations.  Seen in ER & d/c to home.  Continued to have fever & irritability w/occasional grunting.  Seen by PCP & admitted for observation.
the injection site is very red and I have a big rash about 3 inches around the injection site. feeling a little spacey in my head.
Cracked a molar; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH FRACTURE (Cracked a molar) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced TOOTH FRACTURE (Cracked a molar). At the time of the report, TOOTH FRACTURE (Cracked a molar) outcome was unknown. Not Provided      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 provided No treatment information provided    Reporter did not allow further contact
W/in 24 hrs. of adm. (L) thigh swollen, erythematous from injection site to knee. Refused to weight bear. Pt evaluated at urgent care. Returned to office on 9/10/14 - swelling decreased and was walking.
PATIENT CAME IN TODAY WITH A HOT, RED, SLIGHTLY RAISED CIRCULAR RASH ON THE INSIDE FRONT OF HER RIGHT ARM (ABOUT 16 SQUARE INCHES IN SIZE). SHE SAID SHE HAD BEEN FEELING NAUSEOUS ALSO. I MARKED THE EDGES OF THE RASH WITH AN INK PEN SO SHE COULD KEEP TRACK OF IT AND ADVISED HER TO TAKE BENADRYL 50 MG BY MOUTH EVERY FOUR HOURS AND TO FOLLOW UP WITH HER FAMILY DR. I TOLD HER TO GO TO THE ER IF IT GOT ANY WORSE.
Information has been received from a medical assistant regarding a 2-month-old female who received her 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine) on 03-DEC-2002, and experienced redness at the injection site. Medical History: This patient developed redness at the injection site after receiving her 2nd dose of Prevnar on 04-FEB-2003 (see related case #HQWYE511924OCT03). She also experienced a "cellulitis-type event", 2 days after receiving her 3rd and 4th doses of Prevnar on 25-JUN-2003 and 07-OCT-2003 (see related cases #HQWYE511824OCT03 and #HQWYE330220OCT03), respectively.  Product Details: Indication for Prevnar was immunization. Product was administered on 03-DEC-2002. Dose regimen was 1 dose 1 time per day (intramuscular).  Concomitant Therapy: Concomitant medications were not reported.  Event Details: On 05-DEC-2002, 2 days post-immunization, the child experienced "some redness" at the injection site. The redness resolved without treatment. No additional information was available at the time of this report.
C/o upper eyelid swelling and red dry skin to bilateral eyes starting the morning after receiving vaccines, mother feels it is due to the vaccines; denies any other signs of illness; denies any previous vaccine reactions; did have allergy testing the afternoon of the rash starting; took a dose of benadryl last evening which seemed to help with the swelling but dry red skin still present to bilateral upper eyelids and now sides of mouth
This spontaneous report was received from a physician referring to a 11-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 23-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit (F) and the higher was 54 (F) for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.