chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling at injection site; soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling 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 injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient's husband. The age at vaccination was not reported The patient experienced a sore and swollen arm  at injection site after receiving a dose of Shingrix vaccine couple years ago. The reporter did not consent to follow-up. This case has been linked with case US2022046177, reported by same reporter. Note: Conservatively coded injection site events. Clarification had been raised.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022046177:same reporter
Within 15 mins, fever, chills, fatigue, body and joint pain, diarrhea; Within 15 mins, fever, chills, fatigue, body and joint pain, diarrhea; Within 15 mins, fever, chills, fatigue, body and joint pain, diarrhea; Within 15 mins, fever, chills, fatigue, body and joint pain, diarrhea; Within 15 mins, fever, chills, fatigue, body and joint pain, diarrhea; Within 15 mins, fever, chills, fatigue, body and joint pain, diarrhea; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old male patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Within 15 mins, fever, chills, fatigue, body and joint pain, diarrhea on 11Jan2021. AE resulted in doctor or other healthcare professional office/clinic visit. Patient did not have COVID prior vaccination and was not COVID tested post vaccination. Therapeutic measures were taken as a result of events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
Started getting diarrhea/soft bowel movements at end of May 2021. First Moderna vaccine was 4/15/2021, and second one was 5/13/2021.  As of 6/24/2021, I am still having issues a month later for my GI. I also seem to be gassier than usual and occasionally have times of uncomfortable bloating. There are times I had to run to the bathroom - not fun at all. My doctor had me take stool samples, and no bacteria was detected in my stool. He put me on antibiotics for a UTI which didn't help my GI issues. I am scheduled to see a gastroenterologist on 6/25/2021.  I also noticed that the front right side of my right thigh buldges a little above the knee, goes in, then buldges out again as it goes up my leg. I went to doctor for it and he said it feels like my muscle but I should get an ultrasound, which I haven't done yet. I have no pain in this area.
Approximately 10 minutes after the vaccine was administered, reported starting to feel light headed, sweaty and nauseous.  Then reported throat was feeling tight and RN on site reported hearing change in breathing.  RN administered EpiPen and called 911.  EMS responded and transported to ED.  ED record shows resolved symptoms.  No rash, edema, difficulty breathing.  In ED was monitored and discharged.  Received no medications or additional treatment in ED.
increased difficulty with alertness; For five days: Fever 102; aches; tired; 2 days sleeping; cough; sneezing; memory recall; word retrieval; Off label use; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2022 at 16:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "HTN" (ongoing); "Psoriasis" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LOSARTAN; HCTZ; JANUVIA; GLIPIZIDE; FLOMAX [TAMSULOSIN HYDROCHLORIDE]. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer: Unkown), for COVID-19 immunization; Covid-19 vaccine (Dose: 3, Manufacturer: Unkown), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 19Apr2022 at 16:00, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 19Apr2022 at 16:00, outcome "unknown"; HYPERSOMNIA (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "2 days sleeping"; PYREXIA (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "For five days: Fever 102"; PAIN (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "aches"; COUGH (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering"; DEPRESSED LEVEL OF CONSCIOUSNESS (medically significant) with onset 20Apr2022 at 04:00, outcome "recovering", described as "increased difficulty with alertness"; MEMORY IMPAIRMENT (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "memory recall"; SNEEZING (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering"; FATIGUE (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "tired"; APHASIA (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "word retrieval". The patient underwent the following laboratory tests and procedures: Body temperature: 102, notes: fever 102. Therapeutic measures were not taken as a result of depressed level of consciousness, pyrexia, pain, fatigue, hypersomnia, cough, sneezing, memory impairment, aphasia.  Clinical information: No other vaccine in four weeks. No covid prior vaccination: Covid was not tested post vaccination.
Pt recvd vax & exp local reaction @ inject site, lt delotid pruritus, erythema; pt went ot ER; pt indicated that while in ER exp dizziness;
This spontaneous report was received form a nurse practitioner via company representative refers to unspecified number patients of unknown age and gender. The nurse reported that the physician's office had unspecified number patients who were administered GARDASIL (lot # J006236, expiration date: 25-FEB-2016) route, dose and location unspecified on an unspecified date and experienced syncope. The physician inquired "is there increased risk of syncope associated with GARDASIL lot # J006236). At the time of report, the outcome of syncope was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
he was bleeding; This is a spontaneous report from a contactable consumer. A 15-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 25Jul2021 (Batch/Lot Number: FA7484) as dose number unknown, single for covid-19 immunisation. Medical history included Crohn's disease. Concomitant medication included adalimumab (HUMIRA) taken for Crohn's disease, start and stop date were not reported. In Jul2021, it was reported that the patient received a vaccine of Pfizer and when he got the shot he bleed a lot, "a lot and we had to get tissues, we had to get gauze, he was bleeding". It was stated that it was unknown if that's a side effect. No treatment was received. The patient recovered from the event in Jul2021.  Follow-up attempts are completed. No further information is expected.
24 hours post vax, the pt developed a fever for 72 hours. Tests ruled out bacteremia and UTI.
Patient stated she received the first Moderna Covid-19 vaccine on Wednesday March 31, 2021.  Beginning at approximately 5:30 Thursday April 1, 2021 patient's arthritis in the hand of the arm she received the vaccine in was in excruciating pain.  Patient stated that when her arthritis flares the pain is felt in both hands.  This time it was only in one hand.  A couple hours after patient received vaccine she had blood drawn from the arm where she received the vaccine.  Patient described the pain as worse than she has felt before and it woke her from sleep a couple of times at night.   Patient also state she had not taken any ibuprofen or meloxicam for the pain but did use CBD lotion.
Developed vomiting and diarrhea after vaccination also reported chills. Symptoms persisted following day.
nurse gave the patient a shot of trumenba on 28Oct2020, when she intended to give menactra; occasional dizziness in the mornings; This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 11-year-old male patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on 28Oct2020 at single dose for immunization, meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), via an unspecified route of administration on an unspecified date at unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. The nurse gave the patient a shot of trumenba on 28Oct2020, when she intended to give menactra. Patient experienced occasional dizziness in the morning on unspecified date in Oct2020 with outcome of not recovered. After appointment, mother took child to ER since he was still dizzy.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Redness and warmth/swelling on inside arm that vaccine was given. CLARITIN 10 mg daily x 7 days and monitor.
Upon attempting to get out of bed, individual noticed that he had weakness in both lower extremities, and experienced "clumbsiness" while attempting to dress, which required him to sit on the edge of the bed to be able to finish dressing.  The weakness progressed until about 10:00 AM at which time the left was more involved than the right.  Gait was mildly dysfunctional with foot drop noted on the left.  Weakness was noted in the hip flexors, abductors, adductors and tibialis anterior muscles.  Weakness began to resolve later on the afternoon of 10/17/2009 and was >90% resolved by 10:00 PM.  By 10/18/2009, all weakness had resolved.
at 11:50 pt c/o palpitations- O2 sat 100, HR 48-53, BP133/41. given gingerale and mask break w/ improvement.   no lightheadedness or CP. palpitations intermittent. 12:05 vital signs unchanged. ER eval. Pt transported via stretcher for monitoring
Shooting nerve pain from site into base of  skull/upper neck on left side. After 3 weeks this subsided to be replaced by shoulder bone ache. Top part if bone. This lasted for 2-3 months.
ACCIDENTALLY GAVE PT 1 ML INSTEAD OF 0.5 ML. PT ONLY SAID SHE HAD SORE ARM NO OTHER SIDE EFFECTS AS OF NOW
Redness and swelling left arm at injection site.  Advised to apply cool compress and Tylenol PRN.
Vaccines given 2 days ago (flu and Trumenba-both left arm), yesterday with some arm soreness. This am felt like arm is swollen and noticed rash that is tender under side of left upper arm. Some hand and feet swelling today. Denies lip or tongue swelling. No SOB, dizziness. No fever.  Area photographed and marked to watch for spreading. Continue Advil prn comfort and cool compress. F/u tomorrow.     Has Nexplanon in left arm as well.
Patient developed muscle weakness, dizziness, wheezing/shortness of breath, rapid heart beat several hours after immunization.  Patient has been resting.
This spontaneous report as received from a nurse concerning unspecified number of patients of unknown age and gender. Approximately in 2017 (reported as between 30-MAY-2017 and 16-AUG-2017), the patients were vaccinated with improperly PROQUAD lot # M038861 with expiry date: 13-MAR-2018 (dosing details unknown) for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent (lot# unknown). It was reported that the vaccines were exposed to a temperature range of 15F to 46F for a duration of 1 hour. During the previous temperature excursion the vaccines were exposed to a temperature range of 15F to 46F for a duration of 1 hour. Data logger was involved. No adverse effects were reported. There were no product quality complaints. Sender's Comments: US-009507513-1708USA007720: US-009507513-1708USA008039.
Left leg redness, swelling and warmth surround injection site aprx. 12-15 cm in total diameter.
Localized rxn w/ redness, swelling and warmth, but BELOW site of injection, closer to bicep than the deltoid area that injection was administered. About the size of palm of hand.  Counseled patient to apply cold pack, take either Tylenol or ibuprofen .  Red area was traced around with a sharpie pen and counseled to watch for growing size tomorrow (10.17.22) and report to urgent care or her physician, as cellutitis may result.
FLUBLOK was administered to 4 year old female patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00414233) and transmitted to Sanofi on 04-Jan-2021.  This case was linked with 2021SA002156, 2021SA002607, 2021SA002631, 2021SA002726, 2021SA002799, 2021SA002850, 2021SA002575, 2021SA003127, 2021SA003182, 2021SA002085 (same reporter)  This case involved a 4 year old female patient who was administered with a standard 0.5ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (prefilled syringe, lot UJ509AA, expiration date 10 May 2021) once via intramuscular route at the left deltoid for prophylactic vaccination on 22-Dec-2021 (Product administered to patient of inappropriate age).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) both for prophylactic vaccination.   It was a case of actual medication error due to inappropriate age at vaccine administration (latency-same day).   Reporter stated that FLUBLOK had been administered to 11 pediatric patients and would like to know if patients were covered for influenza vaccination for the season  At the time of reporting, no adverse event reported (reported as none).  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 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.
Malaise, headache, joint pain, sensitivity to light, fever, injection site swelling with redness/heat and trouble sleeping starting 12 hours after injection and lasting around 36 hours
Patient given 2n dose of Energix-B, Vaccine was 17 dyas expired.  Patient contacted by telephone and advised of the event. She denied any ill effects.
all my family got sick. My brother and sister.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "all my family got sick. My brother and sister.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: This consumer reported for a male patient (reporter's brother) in response to Non HCP letter sent in cross referenced case.    Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Pt complained that shot burned and stung injection site upon receipt.  The next day the area was sore, hot to touch and extremely red and swollen, also had a hard knot subside symptoms.
I have had intermittent numbness in my left hand for about 1 week. The first 2 days were the worse. It is also resolved but still feels different from my right hand. I have not had any weakness.
This case was reported by a pharmacist via call center representative and described the occurrence of foot pain in a 65-year-old male patient who received SHINGRIX (batch number GL2HR, expiry date 22nd May 2021) for prophylaxis. Concomitant products included SHINGRIX. On 19th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 20th February 2019, 1 days after receiving SHINGRIX, the patient experienced foot pain. On an unknown date, the outcome of the foot pain was not recovered/not resolved. It was unknown if the reporter considered the foot pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist on the line reported that the patient got their 2nd dose and then woke up the morning on 20th February 2019, the patient's right foot was painful, it hurts all the time and more when he walks on it. It has not improved, it has worsened and the pain was very significant. It does not go past his ankle, just his foot.
No signs mild rash began on 3/14/04 by 3/15/04 he had bigger red splotches covering his entire body also eyes were blackened. No fever
Severe oral lichen planus new onset in which I have not had a resolution . Lesions on tongue, inner lips, uvula, and buccal areas. Fatigue
MUSCLE WHERE SHOT WAS GIVEN IS VERY STIFF I HAVE EXTREAM PAIN IF I TRY TO RAISE MY ARM AND ELBOW. WILL ONLY GO UP 50 %
9/23/21: Patient arrived at the ER due to shortness of breath, weakness, urinary frequency, chills, diarrhea, decreased appetite, and bilateral hip pain. Pt states she has had symptoms since her last cancer treatment 9 days ago. She notes having an iron injection at that time as well. Denies any bleeding. Pt confirms her shortness of breath is worse with exertion, and she notes recent falls due to weakness.
pt c/o worsening migraines, fatigue, extreme cold, small bowel obstruction
approx 5 hrs p/vax pt became inconsolable w/high pitched screaming lasting 2 hrs; prior to screaming pt was excessively sleepy; also exp redness & swelling @ site of inject;
Symptom onset 9/3/21. Hospitalized due to COVID. Fully vaccinated.
Wheezing even after inhaler, fever of 101.6, chills, extreme body aches, swollen blood shot eyes, goopiness in eyes and throat, jittery like I was jumping out of my skin, like I was on a high dose of steroid. Next morning I woke up to slight cough that was gone within a few hours. I have never experienced this extreme of a reaction.
Patient reports he had a stroke on 04/18/2022 and now suffers from paralysis of
tired; has no energy; can't think straight; dizziness; he has developed two spots on his right leg where the skin has fell off; two spots on his right leg that the skin fell off and swelling really bad; two spots on his right leg that the skin fell off and swelling really bad; throbbing; bad headache; feels hot and cold; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jul2021 (at age of 61 years old), (Batch/Lot Number: unknown) as dose 2, single for COVID-19 immunisation.  Medical history included two heart attacks, three stent implants, and his lung had separated, also he had tube in his chest. He had to have six bypass open heart surgeries. His first heart attack was at age 55. Patient was taking unspecified concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, via an unspecified route of administration on 15Jun2021, (at the age of 61 years old), in left arm as single dose for COVID-19 immunization. The patient experienced dizziness and he has developed two spots on his right leg where the skin has fell off and are throbbing and swelling really bad for no reason, had bad headaches and feels hot and cold on 16Jul2021 (Friday). The patient stated he can't think straight right now and also stated he is tired, has headaches, and has no energy. If he gets up and walks around he gets dizzy. The headaches are constant. The patient stated he was calling because his son wants to take him to the ER. The outcome of the events was not recovered.
During my first dose,  3 weeks prior to this event, I experienced high fevers (up to 104 degrees), chills, night sweats, joint pain, and I also started menstruating 2 weeks postpartum. At the time I also noticed a drop in my milk supply, and a regression in my baby's ability to latch (unsure if this is related to the vaccination event, but it coincided). During my second dose, date of this reported event I experienced milder symptoms of the same type: fever (up to 103 degrees), night sweats, milder joint pain, and again began to have spontaneous vaginal bleeding similar to a period. I have not discharged any more lochea and believe that the vaccine has again triggered a very distinct and period like vaginal bleeding. My milk supply has again seemed to drop post the second dose. I believe the vaginal bleeding and milk supply decrease are related; the vaccine leading to some sort of hormonal change causing vaginal bleeding or menstruation which can impact milk supply. All of the other symptoms with the exception of milk supply increase resolved themselves within 24-36 hours respectively and did not have lingering effects.
A lot of pain, 3 inch swollen circle around the injection site. The top of the swollen circle was warm and later on itched.