chrisvoncsefalvay/vaers-outcomes huggingface dataset:
knee of the leg its swollen; 3 hours later she was disabled from the waste down, she can not move her legs/pain in the knee on the two legs/The knee of the leg its swollen with tremendous pain and she can not walk; pain in the knee on the two legs; can not move her legs; This is a spontaneous report from a contactable consumer (spouse). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration on 09Mar2021, single dose for covid-19 immunisation. The patient had her first dose of bnt162b2 for COVID-19 immunisation on 16Feb2021. The patient's medical history and concomitant medications were not reported. Patient, 3 hours after having the vaccination, she was disabled from the waste down, she can not move her legs. She is having pain in the knee on the two legs. The knee of the leg its swollen with tremendous pain and she cannot walk. She is worse every day and that she refuses to go to the hospital or clinic. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Patient had Menveo vaccine administered felt lightheaded and team alert was called. Brought back to clinic, vitals done, given juice/crackers and layed down. Dr. notified, came to exam patient. Vital repeated after 20 minutes and discharged in stable condition per Dr. verbal orders.
Raised round 3 inch diameter area noted to injection site with itching noted.  No complaint of pain, soreness, redness or temperature elevation Dermatologist examined and diagnosed as delayed cellulitis.  Prescribed betamethasone cream and instructed to take antihistamine by mouth.
2/5/2021 S/O: Patient endorses 2-day history of rash of trunk, lower extremities, feet.  Rash is pruritic.  Started on torso and then spread peripherally to involve back, legs.  Spares face. Itching improved with Benadryl.  She is 10 days status post second dose of COVID-19 vaccine.  She denies lip/tongue swelling, fever, chills, cough, wheezing, dyspnea.  Patient denies any history of allergies or adverse vaccine reactions.   A/P:  1. Chilblain-like lesions of multiple toes R23.8  -Rash concerning for pseudochilblains associated with COVID-19 infection. -Patient otherwise with no signs of Covid infection. -Suspect adverse drug reaction to vaccine.   -We will send patient for PCR testing to rule out active infection. 2. Pruritic rash L28.2  -Suspect drug reaction.  Recommend continue antihistamine twice BID.  -Rx Medrol Dosepak  2/6/2021 COVID Test Negative  2/8/2021 Patient states her rash is gone, toes are improving, and Medrol Dosepak is working well.
Severe body aches, entire body. My scalp hurt, my ribs, everything. This started 13 hours after injection. Fever, chills, unable to walk or stand, exhaustion but unable to sleep. My vision also seems to be impaired. I'm not seeing as well as I should be.  Random heart palpitations. Sore arm at injection site, red and warm to the touch.
Severe Joint Pain throughout entire body. Unable to stand from a sitting position on own. Taking OTC anti-inflammatory 4 times per day. It helps but the pain is not going away. Absolutely no joint pain for entire life previous.
No adverse event. Dose #1 had been given @ 20 weeks of age, so series was started for late and he should not have been given dose #2 or #3. No adverse event
This spontaneous report was received from a registered nurse and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-DEC-2018, the patient was vaccinated with improperly stored dose of VAQTA, lot # R018935, expiration date 05-SEP-2019 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
received first dose of Shingrix and never received the second; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 19 January 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received first dose of Shingrix and never received the second).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-Sep-2023 The reporter stated that patient received first dose of Shingrix and never received the second dose to complete the series which led to incomplete course of vaccination. According to the reporter the treating physician was not aware. No other information provided by the reporter. The reporter did not consent to follow up.
Approximately 24 hours after receiving immunizations (DTaP, IPV in right leg), patient developed marked swelling, redness and increased warmth involving right thigh from proximal thigh down to and involving right knee. She did not have fever and was ambulating without difficulty. Secondary to physical exam findings consistent with cellulitis, she was admitted to the pediatric ward for IV antibiotic therapy. She responded well to IV therapy and was discharged after 24 hours. She was treated with Benadryl also during hospitalization.
BODY ACHES; WAS IN BED ALL DAY; CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced body aches, was in bed all day, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, body aches and was in bed all day was not reported. This report was non-serious.
8:30 client arrived/received H1N1 vaccine. 9:20 client c/o itching all over - no wheezing not at this time, alert x5. Fiance called will pick-up client and stay with her. 9:30 BENADRYL 50 mg IM Rt arm no wheezing. 9:50 home with fiance.
Nauseous, Chills, Body Aches, Headache, Fever. Went to ER next day (01/21/2016 9:00 AM) received 2 IV, Motrin, Tylenol, and Zofran. Left hospital with 101 F fever.
Pt. received Tdap x 2 9/30/13, 12/27/13. Reaction: None noted or known.
No additional adverse events.; on 1/13/2020 a patient was administered an improperly stored PROQUAD; This spontaneous report was received from a medical assistant referring to a 3-year-old patient of unknown gender. The patient's pertinent medical history, historical drug, concurrent conditions, and previous drug reactions or allegies were not reported.     On 13-JAN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot number S022913, which was verified to be valid, expiration date reported and validated on 19-JAN-2021 (strength, dose, vaccination scheme, anatomical location and route of administration were not provided), as prophylaxis (product storage error). The vaccine was reconstitued with a properly stored sterile diluent (DILUENT MRK) (lot number and expiration date were not reported). The administered dose, was exposed to a temperature between 15 degrees Fahrenheit (F) to 46 degrees F (36.86 F) during a time frame of 9 hours and 49 minutes. Furthermore, there was a previous temperature excursion of 15 degrees F to 46 degrees F (19.13 F) during a time frame of 1 hour and 30 minutes. There was no digital data logger involved. No additional adverse events were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA002261:
devel temp 106.2 & 8 hrs later p/inject temp lasted x 48 hrs 102-103; appetitie off x 12-15 hrs p/inject;
ITP: INITIAL ONSET: 3PM NOTICED EXCESSIVE BRUISING, 6PM PETECHIA ON BACK AND LEGS, 11PM MOUTH BLEEDING; 11/21/16 HOSPITAL ADMISSION WITH PLATELETS AT 0K.
Next day-neck/shoulder spasms-jaw pain-back pain ER visit-FLEXERIL/PERCOCET-2 days later-ER-still in spasms and pain-injection for pain-3 days later orthopedic exam and xrays-pain not caused by neck-fever/chilld face pain-weakness-shallow breathing.
Patient developed respiratory infection three days after the receipt of AVA #3. Symptom: Fever Start: 04/25/2008; Symptom: Nausea w/vomiting Start: 04/25/2008
Can't move her arm from the elbow up; This spontaneous case was reported by a pharmacist and describes the occurrence of MOVEMENT DISORDER (Can't move her arm from the elbow up) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced MOVEMENT DISORDER (Can't move her arm from the elbow up). At the time of the report, MOVEMENT DISORDER (Can't move her arm from the elbow up) 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.  Concomitant product use was not provided by the reporter. No treatment information was provided.
In late June 2017 he received a Dtap vaccine. Immediately after he started displaying sensory symptoms like covering his ears when music was on, or when a toilet flushed and covering his eyes in groups of people. Approximately 10 days after he came down with an extremely high fever and was so disoriented he didn't know where he was laying in his own bed. Crying "mommy, where am I?". Wired with eyes darting back and forth, lethargic, and couldn't follow my finger back and forth. The following days he was disoriented again and said his head hurt badly, he could hear "bells", and that it was noisy. His eyes were so glassy he didn't look like himself. He would be fine for a bit then get extremely upset because his head hurt so much. Since then he can't tolerate crowds, says that the volume has been turned up and has started rubbing his earlobes for comfort. He now seems disturbed in these situations and rubs his head, is aggravated and not himself.
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a male patient of an unknown age 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 DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. No treatment information were provided.
4inx2in red, raised, warm, painful to touch - approx. 2 inches below injection site.
have had COVID 4 times and I have had 5 Pfizer shots; have had COVID 4 times and I have had 5 Pfizer shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "have had COVID 4 times and I have had 5 Pfizer shots". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I have had COVID 4 times; Positive, notes: I have had COVID 4 times; Positive, notes: I have had COVID 4 times; Positive, notes: I have had COVID 4 times. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
12/04/2017 given KINRIX Vaccine (L) thigh IM in office on 12/12/17 mom called to advise same night pt had high temp 104 with seizures. Broke out with red dots widened. Pt was taken to E.R. for eval.
Muscle aches, Fever, Headache, Teeth hurt, and on the 2nd day redness/heat, and itchy at shot site.  Most symptoms went away after 24 hours. My arm is still experiencing the sore, red, heat and itch as of today.
28MAY96 t98.2, parotid swelling on rt, noted by parent when child awoke 28MAY96;had c/o pain below rt ear on evening of 27MAY96;symptomatic tx only
patient called back the next day and stated her throat was swelling and had to take Benadryl.
hives noted to forehead and neck, 12.5mg of Benadryl administered, observed for additional 15 minutes, no acute distress, no difficulty breathing, o shortness of breath.
This case was reported by a physician and described the occurrence of joint pain in a 39-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 17 August 2009 at 12:00 the subject received unspecified dose of BOOSTRIX at 0.5 ml in the left arm. On 18 August 2009, the day after vaccination with BOOSTRIX, the subject experienced joint pain and swelling. At the time of reporting the events were unresolved. The physician considered the events were possibly related to vaccination with BOOSTRIX. Follow-up information received on 31 August 2009 indicated that the events of joint pain and swelling improved and then reportedly resolved. It was additionally reported that these events were serious in that they jeopardized the subject or required intervention.
coughing 30JAN97 given entex;fever 4FEB97 given med;pt recv flu vax 11FEB97;
pt recvd vax;mom said pt had fever 104 for 4 days;t would go up & down w/ apap;persistent crying for 20 out of 30 hrs;mom spoke w/ MD,said to watch her;no szs or convuls per mom;clinic said pt had > risk to have prob w/ dtp because dad did;
Severe soreness at injection site, dark red color from shoulder to elbow,, chills, fever (100.1),  loss of appetite, vomiting, fatigue, weakness all lasting one full week after injection. After one week redness of arm remains, mild pain.
A rash with red spots broke out between 4-6-21 and 44-17-21. The rash was itchy and broke out continually. I was prescribed a topical ointment, triamcinolone 0.1% and methyiprednisolone 4 mg. After the first day of medication the rash and itch was lessened.
After the shot of HPV vaccine the first shot I got a bad body rash that was extremely itchy.
Flu like symptoms; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Pancreatitis (manifestation by pancreatitis), Abstains from alcohol, Wheezing (manifestation by wheezing) and Oral surgery. Concurrent medical conditions included Dry mouth ("There was a unspecified medication that caused the dry mouth and was told by the physician that crohn's disease might also caused dry mouth.") since 2012, Drug allergy (Methotrexate allergy), Non-smoker, Drug allergy (imuran allergy), Drug allergy (asacol allergy) and Crohn's disease.   In 2014, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK Citrate Free (1- 2 wk). On 26-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.  It was reported that the patient had oral surgery. She also had flu like symptoms and fatigue due to covid vaccine, and missed two weeks of work and three weeks with one. Patient underwent root canal three to four times in Jan2022 and Mar2022. She underwent root canal because of dry mouth. There was a unspecified medication that caused dry mouth and was told by the physician that Crohn's disease might also cause dry mouth. The dry mouth did not worsen she started taking Humira. It was unknown if patient was enrolled in Covid-19 vaccine trail.  No treatment information provided.
Patient developed a pounding headache within one hour of receiving vaccine. The headache subsided that evening but returned the next day. Patient also complained of muscle aches and queasiness on the evening of the injection. Patient was all right by 1PM the day after the injection.
Patient called Tuesday night complaining that the site of his Flu vaccination has developed redness & itches & discomfort. I advised him to take Ibuprofen & BENADRYL.
high pitched crying x 10-24 hrs p/inject; t103 p/inject; diarrhea, vomiting during 24 hrs following inject; seen by MD w/treatment;
Pt got pneumonia after 2 days after getting shot and could not move the arm for about 3 days. Had to go to ER & was at hospital for 1 day. He is treated with antibiotics.
FLU; BODY ACHE; SORE ARM; RADIATING PAIN FROM SHOULDERS AND JOINT PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included it was unknown if patient consume alcohol, smokes or had any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced flu, body ache, sore arm, and radiating pain from shoulders and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu, body ache, sore arm, and radiating pain from shoulders and joint pain. This report was non-serious.
STIFF MUSCLE; STIFF JOINTS; SORE BODY; FEVER; This spontaneous report received from a patient concerned a 31 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A,expiry: UNKNOWN) dose was not reported, in left arm administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 04-APR-2021, the subject experienced fever. On 04-APR-2021, the subject experienced stiff muscle. On 04-APR-2021, the subject experienced stiff joints. On 04-APR-2021, the subject experienced sore body. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, stiff muscle, and stiff joints on 05-APR-2021, and sore body on 06-APR-2021. This report was non-serious.
Patient called on 2/26 asking if she should delay or cancel or second dose. On day 6 after first dose, she stated rash on chest, day 7 rash spread to face, day 8 she started to have some swelling. She went into urgent care and got prescriptions for a steroid, famotidine, Benadryl and zpak. She stated rash improved until the end of the steroid course and started to worsen again. She is calling urgent are again for follow-up.
Muscle aches at the injection site and low back pain x 2 days after Moderna vaccine. Right side of the face pain on and off, lasts 10-30 min, frequency at least 5 times daily started 4 days after Moderna vaccine. Sounds like trigeminal neuralgia. Patient thinks it is related to Moderna vaccine and doesn't want to get 2nd dose
Patient got extremely low blood sugars on the night of getting both a PREVNAR 13 and FLUZONE HD shot. But they are also diabetic and on insulin. They were taking variable dosing of insulin. After reviewing with the patient's friend, I suggested that the hypoglycemia episode was most likely due to insulin problems or not eating enough food.
Crying almost nonstop, easily startled which sets off crying, very little sleep.  Knot noted in both legs, moreso in the left with small redness, no "fever' in leg noted.  Also teething without help from Orajel.
Pregnant woman received vaccine; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant woman received vaccine) in a female patient of an unknown age 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant woman received vaccine). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant woman received vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.  Company comment: This spontaneous case of maternal exposure during pregnancy concerns a female patient with no relevant medical history reported.  There were no associated adverse events. Rechallenge was not applicable. The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous case of maternal exposure during pregnancy concerns a female patient with no relevant medical history reported.  There were no associated adverse events. Rechallenge was not applicable. The benefit-risk relationship of drug is not affected by this report.
Terrible shoulder pain with extremely limited range of motion spoke with orthopedics (2 different physicians) and went on Meloxicam po QD with omeprazole daily the pain and range of motion improved over the past months but is now at a seeming steady state with perhaps a 70% improvement