chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm pain; arm itchy/itchy is getting bigger and getting worse; really bad, like a welts; poilus skin; really hurt at the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm pain), PRURITUS (arm itchy/itchy is getting bigger and getting worse), URTICARIA (really bad, like a welts), PRURITUS (poilus skin) and VACCINATION SITE PAIN (really hurt at the injection site) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), PRURITUS (arm itchy/itchy is getting bigger and getting worse), URTICARIA (really bad, like a welts), PRURITUS (poilus skin) and VACCINATION SITE PAIN (really hurt at the injection site). At the time of the report, PAIN IN EXTREMITY (arm pain), PRURITUS (arm itchy/itchy is getting bigger and getting worse), URTICARIA (really bad, like a welts), PRURITUS (poilus skin) and VACCINATION SITE PAIN (really hurt at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Blood shot rt eye, light sensitivity, rt sinus draof mucous , head ache over rt eye
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 20-NOV-2014, the patient was vaccinated with a dose of M-M-R II (therapy type, route, dose, frequency and lot # were not reported), which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Patients mom states- injection site was swollen. Patient complained of pain in the arm. Advised per her mom to take a shower and the patient "passed out". per mom this happened at 7pm on 3/9/07.
RED LOCALIZED REACTION AT IMMUNIZATION SITE, HOT WITH LUMPS. WENT AWAY AFTER ONE WEEK. ONE MONTH LATER AWOKE WITH RED LOCALIZED REACTION RED WARM TO TOUCH WITH THREE WHITH BUMPS INSIDE RED AREA AT INJECTION SITE. STAYS ABOUT 20 MIN THEN FADES AWAY. RETURNS ABOUT EVERY 6-8 WEEKS HAD LAST REACTION TODAY 9/23/05. APN OBSERVED AREA AND MONITORED UNTIL REDNESS DISAPPEARED, APPROX TWENTY MIN LATER.
Extreme swelling of both thighs; especially the right thigh. Very painful to touch. Occurred within 2-3 hours of receiving vaccinations.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The registered nurse who was able to provide lot numbers and expiration dates for PROQUAD (Merck) (lot # K005644; expiration date: 17-OCT-2015) 10 doses were available, none were administered and PROQUAD (Merck) (lot # J008157; expiration date 08-JAN-2015) 10 doses were available, 7 were administered. Additionally the reporter provided lot numbers and expiration dates for another vaccination vaccine VARIVAX (Merck) (MARRS #1408USA0066440). Both vaccinations went through a temperature excursion. As of this time no adverse experiences had been reported to the health department of those patients who were administered the out of range vaccinations. This is one of several reports from the same source. Additional information has been requested.
cold sweats; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), PYREXIA (fever) and HEADACHE (headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced COLD SWEAT (cold sweats), PYREXIA (fever) and HEADACHE (headache). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, COLD SWEAT (cold sweats), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.            The action taken with mRNA-1273 in response to the event was not applicable. Concomitant medication information not provided.
Information has been received from a nurse practitioner concerning a 19 year old female with no medical history who on 06-SEP-2007 was vaccinated IM in the deltoid with the first dose of the GARDASIL vaccine (yeast). On 19-NOV-2007 the patient was vaccinated in the upper thigh with the second dose of GARDASIL vaccine (yeast). In March 2008, the patient was vaccinated with the third dose of GARDASIL vaccine (yeast). After the first dose the patient was unable to lift her arm and had to go to the neurologist. A month later she developed a rash on her neck. A month after the second dose the patient broke out in rash on her lower body underneath the skin that looked like "bug bites". The patient has been experiencing rashes since the third dose. The rash clears out then comes back again. The patient was seen by multiple specialists and blood work was done that came back abnormal and the nurse asked the patient to call her with the outcomes of the blood work. The patient outcome was not recovered. Additional information has been requested.
PREVNAR given in R deltoid on 26 Oct 2018, pt reports arm becoming red 28 Oct 2018 which became worse. Pt walked into clinic on 10/31/18 to have arm assessed. Was seen by Dr. in clinic diagnosed with Cellulitis of R bicep and given Dicloxacillin 250 mg one tab by mouth four times a day and Diphenhydramine 25 mg one capsule by mouth every six hours as needed for itching and swelling of arm.
Warm, swollen, red at site of injection. Later diagnosed as staph cellulitis at f/u appt.
Left arm has been sore since client received influenza vaccine on 10/23/03. Pt reports that it is painful to move or lift her left arm. Pt states that it feels that something inside isn't right.
administration date: 26Apr2021, dose number: 1/ administration date: 10May2021, dose number: 2; Rash showed up on face 8 days after dose #2; Body aches began the day after dose #2.; The day after receiving dose #2 of the vaccine Headache began and lasted over a week; shingles; One week after receiving dose #2 skin sensitivity on face began; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received bnt162b2, second single dose via an unspecified route of administration, administered in Arm Left on 10May2021 10:30 (Batch/Lot number was not reported) for covid-19 immunisation at age of 35-year-old. The patient previously received first dose of bnt162b2 26Apr2021 at 10:30 for COVID-19 Immunization on arm Left at age of 35-year-old. The patient's medical history was not reported. Concomitant medications were none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The day after receiving second dose of the vaccine headache began on 10May2021 and lasted over a week. Body aches began the day after second dose on 11May2021. One week after receiving second dose skin sensitivity on face began in May2021. Rash showed up on face 8 days after second dose in 18May2021. Regulatory Authority visit on 21May2021 confirmed shingles. The events as resulted in emergency room/department or urgent care. The patient received Antiviral medication as treatment. The outcome of event headache was recovered in May2021 (duration: 1 week), outcome of the other events was not recovered.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
upset stomach; extremely tired; lethargic; felt off; soreness at the injection site; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site), NAUSEA (nausea), ABDOMINAL DISCOMFORT (upset stomach), CHILLS (chills) and FATIGUE (extremely tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site), NAUSEA (nausea), ABDOMINAL DISCOMFORT (upset stomach), FATIGUE (extremely tired), LETHARGY (lethargic) and MALAISE (felt off). In March 2021, the patient experienced CHILLS (chills). On 12-Mar-2021, VACCINATION SITE PAIN (soreness at the injection site) had resolved. On 13-Mar-2021, NAUSEA (nausea) and ABDOMINAL DISCOMFORT (upset stomach) had resolved. In March 2021, CHILLS (chills), FATIGUE (extremely tired) and LETHARGY (lethargic) had resolved. At the time of the report, MALAISE (felt off) had resolved.            Concomitant medication use was unknown. Treatment information was unknown.    Reporter did not allow further contact
She reports that her entire left arm was "achy" right after receiving the immunization on 5/17/12. She had taken some aspirin that same day for the achiness and pain seemed to be improved on 5/18/12 (about 18 hours after the immunization was administered). However, patient reports that later in the day on 5/18/12, she noticed that the left arm immunization site became red and painful to touch (including an area of about 3 inches by 6 inches) around the immunization site. She also felt like she ran a low-grade fever (but did not check her temperature) and had generalized body-aches, and felt slightly nauseated for about 24-30 hours after that. The original area of redness and pain around the immunization injection site did resolve, but the redness and pain seemed to move to the inner aspect of her upper arm for about 12 more hours and has since resolved. Patient states that all symptoms had resolved about 56 hours after immunization was given.
sore arm after first dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm after first dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concomitant products included RIVAROXABAN (XARELTO), ATEZOLIZUMAB, CARBOPLATIN, MORPHINE SULFATE, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]), PRIMIDONE, FLUOXETINE, ONDANSETRON, PROCHLORPERAZINE (COMPAZINE SPANSULE), RANITIDINE, ALPRAZOLAM (XANAX) and DOXYLAMINE SUCCINATE (UNISOM 2) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm after first dose). At the time of the report, PAIN IN EXTREMITY (sore arm after first dose) 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.   Other medication: Albuterol inhaler and nebulizer.   This case was linked to US-MODERNATX, INC.-MOD-2021-054191 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054191:2 dose
VARICELLA - redness / swelling 7/10/09 GARDASIL -  Dizziness, light headed - almost fainted, fever X 48 - 72 hours
Patient presented to emergency department with 4/4 positive findings for systemic inflammatory response syndrome and lactic acidosis associated with recurrent right lower extremity cellulitis secondary to skin grafting of flame burn sites (45% of total body surface area) suffered 1 year previously. Cultures were positive for methicillin susceptible and resistant Staphylococcus aureus and multi-drug resistant Pseudomonas aeruginosa. Fluid resuscitation and IV antibiotics were initiated and without further eventualities patient was discharged home with follow-up care to include extended outpatient IV antibiotic therapy.
Vaccine given to patient less than 18 years old. The vaccinator miscalculated the age of the patient when asked her birthdate. The patient was accompanied by parent. Both signed the pre-vaccination screening form, which stipulated the required age of 18 for the Janssen (Johnson & Johnson) vaccine.
Patient presented with complaints of feeling "hot" all day after receiving shot, nauseous, having "ear pressure" and "numb lips".
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: pt has history of panic attacks like once a month-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: pt statesm has a history of these panic like attacks like once a month- this episode happened few minutes after giving vaccine - pt had rininging in ears and temp vision lost and lethargic hadnt eaten since noon and was out in sun - vitals was normal called 911 emt checked her out vitals norma- episode lasted about 15 min- gave pt something sweet to drink - seem like her blood sugar was low or she had panic attack but she is following up w pcp in morning - advsied call 911 if happens again-
Near syncope episode with 10 mintues cool compresses to neck and head, apple juice -> left office well at 30 mins later.
bell's Palsy; she experienced swelling of her left underarm where she got her shot.; Lymphadenopathy; experienced facial swelling (left side of her face); This is a spontaneous report from a non-contactable physician via Medical Information Team.   A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration in the left arm on an unspecified date in Jan 2021 as dose 1, single for COVID-19 immunization. Medical history included covid-19 from Jul2020 to an unknown date. The patient's concomitant medications were not reported. The patient got her first dose of the Pfizer Covid 19 vaccine back in Jan and after her first dose On an unspecified date patient experienced swelling of her left underarm where she got her shot. Stated it was lymphadenopathy. patient also experienced facial swelling (left side of her face) and bell's Palsy. she went to her doctor and she was given Prednisone 50mg for 5 days as she was diagnosed of bells Palsy. patient wanted more information specific to Bells Palsy and patient was asking if she could get the second dose of the vaccine. The clinical outcome for the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.  ; Sender's Comments: based on the strong temporal relationship the events bells palsy , lymphadenopathy,facial swelling and the suspect vaccine BNT162B2 cannot be ruled out completely. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Vaccine administered 11/9/09. Within 1/2 hr - 40 minutes pt became tired and very warm and irritable through out the same night. Hoarse voice and fever same night. Fever next day 11/10/09 103F. Pt's feeling much better today 11/11/09.
Patient had fainted, pharmacist used ammonia salt to wake pt up and pharmacist had called 911. Patient was fine when he left.
rash on bilateral sides; red/pink in color appear to be scratched. No bleeding or exudate present at this time. Client has been using Bactine spray on it and "it looks better".
On Dec 31st she started having chest pains felt like her heart was racing. Back Pains. She went to ER and they found multiple blood clots in her lungs. Went to go see primary care still was having chest and back pains.  She was referred to a cardiologist. She was told she has to stay on blood thinners for the rest of her life. She never had these issues before she received the vaccine.
pt recv vax; pt tested pos for Hep B when donating blood;previously pt tested neg;
RED RASH ALL OVER BODY EXCEPT  FACE; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, sulfa allergy, and lobster allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the subject experienced red rash all over body except face. Treatment medications included: menthol/zinc oxide, and triamcinolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red rash all over body except face. This report was non-serious.
40 minutes after receiving vaccine pt c/o abdominal discomfort. when asked said she did not eat breakfast
Itchiness at the injection site: Started 03/18/2021 Evening -  Redness at the injection site: Started 03/19/2021 Morning -
The patient has had no side effects that she is aware of; Medical Assistant called stating a 55 year old female received the GARDASIL 9 vaccine on July 8, 2022 and would like to know if the patient should receive all 3 vaccines in the series. Information provided from medical information letter. Caller refu; This spontaneous report was received from medical assistant and refers to a 55-year-old female patient. The patient's medical history, current conditions, concomitant therapies, concurrent conditions and previous drugs reactions or allergies were not reported.  On 08-JUL-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 millimeter (mL) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age). The patient has had no side effects that she was aware of (no adverse event). The reporter would like to know if the patient should receive all 3 vaccines in the series.
Information has been received from a physician concerning a 22 year old female patient with no pertinent medical history and no known drug allergy who on 07-JAN-2009 was vaccinated with the first IM dose of GARDASIL (lot # 659184/0843X).  Concomitant therapy included hormonal contraceptives (unspecified).  On 07-JAN-2009 the patient experienced redness of the eye, bronchospasms and rash pennciallian.  The patient went to ER (it was not known if the patient was admitted).  At the time of this report, the physician stated that the patient was fine.  Redness of the eye, bronchospasms and rash pennciallian were considered to be immediately life-threatening.  Additional information has been requested.
Ill; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unwell. On an unknown date, the outcome of the unwell was unknown.   It was unknown if the reporter considered the unwell to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for himself or herself. The age at vaccination was not reported. The patient received shingles vaccine and was ill. The reporter did not consented to followup as no patient details reported.
post vaccine syncope. lowered to floor, consciousness returned. transferred to observation tent, recovered, sent home
soreness began that day.  I stretched according to instructions.  Soreness persists 3 months later...severe soreness so that my range of motion in left arm is severely limited
Information has been received from a nurse practitioner concerning a 22 year old female who was vaccinated IM with the first 0.5ml dose of GARDASIL on 21-JAN-2009. On 21-JUL-2009 the patient was vaccinated IM with the third 0.5ml dose of GARDASIL (Lot#661044/0548X). Concomitant therapy included NUVARING. On 25-JUL-2009 the patient developed a red, widespread, "sunburn-like" rash, fever of 101.9F, nausea, diarrhea and extreme fatigue. The patient also fainted at home on 25-JUL-2009. The patient was seen in the office on 27-JUL-2009 and was referred for evaluation by her unspecified primary care physician. At the time of report the patient's status was not recovered. Follow-up information has been received from a registered nurse who reported that this is 22 year female student. As of 27-JUL-2009 the symptoms persisted and the patient will be going to the emergency room for further evaluation. The nurse practitioner was unsure if the events were related to GARDASIL. At the time of this reporting the outcome was reported as not recovered. Additional information has been requested.
Extreme heart palpatations.  Sweat, fever, dizziness, blackout (unconcious), chest pain, nausea, loss of appitite, burning in chest and injection site.
5/26/06 PM left arm swelling shoulder to elbow, positive itch, warm to touch, positive redness, painful to touch, cap refill, no fever, TX cephalexin 250 mg/5ml susp 5 ml PO Q 60 x 10 days, per ER physician, 5/30/06 swelling and no redness.
On 3/27/2021 had" black out" at around 9:30am drove to another city without any knowledge. Proceeded to home without any knowledge. My children not aware I was in a "black out" situation. I slept for four days on and off without knowledge of this. My children became aware something was wrong when I was acting strangely the times I was awake and that I did not go to work for three days (very unusual for me to miss work) Wednesday 3/31/2021, I finally started coming out of this" black out ", not knowing where I was or who my children were. My cousin came after my children called her and took me to the medical center. My blood pressure was through the roof as was my heart rate. I do not recall what they were. I still was not totally" with it" and left the emergency room without treatment because of E.R. doctor. There is a record of me being there as I was billed for the date 3/31/2021. They did manage to get an EKG.
Vertigo for 8 days following vaccination, sudden head movements induced head spinning. No nausea. Resolved spontaneously 8 days after vaccination. Red and swollen at site of injection approximately 2 days after vaccine, lasted for 2 days.
06/11/08 4:00PM home from school. "Flushed", c/o fatigue and went to bed early - reported by Mother.  06/12/08 over slept, c/o headach, fatigue. No fever and appeared lethagic.  Unusual behavior.