chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt called and said her arm is red and raised but have no pain in the arm that pt got the shingrix vaccine. rec. pt to ice the area and take ibuprofen and check with pt tomorrow. Checked with pt the day after pt states redness at site is going away, still raised and warm.  advised pt to call dr. Otherwise pt is feeling fine.
AT THis TiMe, "FeveR BlisTeRs" on LeGs. 18 wATeR FiLLeD BLisTeRs, Very ITcHy FROM 08/24/20. STiLL occuRING, NOT AS FREeQUeNTLy. I GET FLU SHoT EVeRy year. THis is THe FIRST TIMe THIS HAPPeNeD. My WiFe, Rec'D SAMe SHOT FoR THe FIRST TIMe. HeR CONDITIoN HAS BeeN MucH Less Irritating, SeveRe THAN MINe. We've TReATeD THe BLISTeRS + ITCH WITH CORTIZONe CReAM + BeneDRyL TABLeTs. BoTH HAVe HeLPeD. THANK YOU FOR YOUR INVALUABLE WORK. Be SAFE
Pt recvd vax & exp dizziness, vertigo, syncope, h/a, lymphadenopathy, heartburn, visual sensitivity, sweating, neck & shoulder pain, nightmares, muscle spasms, agitation, irritable, fatigued & weak; 24AUG92 migraine;
About 30 hours after vaccine, patient complained of pain, erythema, and large right groin lymphadenitis versus lymphadenopathy and right thigh erythema.
Bad aches and pain. It was difficult to walk because of the aches. I stayed in bed the whole day, except to go to the bathroom. Arm soreness, super tired, cough, aches went away the next day.
Received vaccine 11/9/2010 at approx. 0830. Have seizure that day leading to hospitalization.
Sore  injection sight when in motion. Woke 3:00 a.m. massive headache. Took one Advil, back to sleep. Up at 5am Feeling a bit "off"   Tired, later (10:00 am.) nausea, a little hyper, dizzy and noticeably off  balance. Now 11:30 am, back to bed.
Patient recieved Moderna vaccine instead of Pfizer at age 17 (Both doses.) No adverse effects.
severe itchiness; severe rash; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (severe itchiness), RASH (severe rash) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced PYREXIA (fever). On 22-Feb-2021, the patient experienced PRURITUS (severe itchiness) and RASH (severe rash). On 21-Feb-2021, PYREXIA (fever) had resolved. At the time of the report, PRURITUS (severe itchiness) and RASH (severe rash) outcome was unknown.            Treatment details included allergy medicine, not specified. no concomitant medication provided
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history or concurrent conditions. Concomitant therapies included acyclovir and sterile diluent (manufacturer unknown).  The patient was on a long term dose of acyclovir, 400 mg twice a day for "years". The pharmacist reported that the patient was vaccinated with ZOSTAVAX 19400 PFU, "1 dose" for prophylaxis (route of administration, lot number and expiration date were not reported). No adverse effect reported. No product quality complaint was filed.
Swollen, tense and red right upper arm, around injection site. This occurred 72 hours after vaccination and resolved in 3 days.
The patient reported tingling in throat, slight headache, and numbness in upper lip.  No SOB noted.  Pt drank water and her symptoms subsided.
maculo-papular rash 7 days post inject; treated w/Hismanal, once daily for 7 days;
Information has been received from a pharmacist concerning a 51 year old female registered nurse with no pertinent medical history or drug allergies who on 05-NOV-2007 was instilling the diluent into vial for 0.65 ml dose of ZOSTAVAX (lot# 658395/0966U) and the entire contents of vial splashed into her left eye, and on her face and neck. There was no concomitant medication. The eye was immediately flushed with water and her face and washed with soap and water. No labs or diagnostic studies were performed. Her face was tingling and the eye was irritated. The patient was not recovered. There was a product quality complaint involved. Additional information has been requested.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous "hearsay" report received from other health care professional concerned an 89 year old female of unknown race and ethnic origin. 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) 1 total, 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.  It was reported that, " a employee called on 01-Feb-2022 to report that a consumer had confirmed covid-19 infection (suspected covid-19 and suspected clinical vaccination failure) that was diagnosed in November of 2021. The employee heard this info through a state representative. The patient in question received the covid-19 vaccine in MAR-2021. The caller did not have any other details about the patient but added that, the patient had a mild infection but made a full recovery".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220204251-covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Information has been received from a female with penicillin allergy, sulfonamide allergy and LEVAQUIN and certain drops allergy who in 2000 was vaccinated with PNEUMOVAX vaccine (manufacturer unknown) and did not have a reaction. The patient mentioned that she had a reaction to a pneumonia vaccine (unspecified which one). In 2005, at a different office she received the vaccine and experienced swollen gland, muscle pains and aches and painful welt on upper arm. The patient sought medical attention. At the time of the reporting, the patient had recovered. No further information is available.
Sleepy; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy) and FATIGUE (exhaustion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054c21a and 009021a) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepy) and FATIGUE (exhaustion). At the time of the report, SOMNOLENCE (Sleepy) and FATIGUE (exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: (High) heart rate rising fast from doing non hard activities.         No concomitant medications were reported.   No treatment information was provided.      This case was linked to MOD-2021-261475.
patient said "I feel high", appears shaky, DM-sugar ok this AM; resolved with juice and crackers BP 128/70 P 76
Patient received influenza vaccine 10/24/08.  Patient called 11/12/08 stating he has been experiencing numbness and tingling in left arm and arm since receiving the vaccine. Spoke with physician who instucted patient to be seen at student health. Patient reports he will go 11/14/08 at noon. Message was left for patient on Fri 11/14 in the afternoon, Sat 11/15 and Monday 11/16.  As of Wed 11/17 patient has not called back to notify us of outcome.
The Patient was sitting on a chair when Vaccine Gardasil was Administered. Then immediately her eyes rolled back, she lost consciousness and her body fell forward. After which the patients upper body started to shake and her arms were jerking. This lasted for 45 seconds- 1 min and then she regained consciousness. She complained of a headache, weakness and dizziness. I checked her pulse which was 76 bpm. We had her lay down for 30 min and drink some water after which she felt better.
She woke up and was sitting in the kitchen and had aches and pain all over and she wasn't feeling good. She laid down to rest and took pain medication before laying down. Significant pain at the injection site on the left arm.
Pain from shoulder to wrist  (2 days) Night sweat (1 night) Headache (2 days) Lack of appetite (2 days) Nausea (1 day) Fatigue (2 days) The headache and  nausea seem worse on the 3rd day
This spontaneous report was received from a physician via company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 08-SEP-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 "10 Single DS 0.5 ml LVls 10SDV", lot # K004148, expiration date 10-MAY-2015 (route was not reported). This vaccine was improperly stored exposed to temperature excursion for a sum of 72 hours at a lowest temperature recorded of 34 degrees F (1.111111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complained involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient developed a raised hyperemic non pruritic rash at lateral aspect  of site of injection. Ice was applied afterward 32 days before rash appeared. He had no improvement after 3 days.
Pulmonary Embolism in right lung, lower lobe. Heparin for two days in hospital and Eliquis starter pack once I was discharged
pt recv vax & following AM c/o itching, redness & a lump @ the lower inj site;pt c/o h/a, T101 w/chills, arthralgias & bilat chest pain;to MD 24NOV97;dx local rxn w/poss infect;rx pred & keflex;29DEC97 MD office resolved soft tissue nodule;
Diahrea with watery stools at least 5 times a day even during urination.; This is a spontaneous report from a contactable consumer (patient). A 83-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201,) via an unspecified route of administration administered in left arm on 10Feb2021 12:30 am at single dose for COVID-19 immunisation. Medical history included sleep apnoea syndrome, Penicilin Allergy. The patient was not tested for covid prior vaccination and post vaccination. The patient experienced diarrhea with watery stools at least 5 times a day even during urination on 10Feb2021 21:00. The treatment was not received for the event. The outcome of the event was not recovered.
Information has been received from a physician concerning an approximately 42 month old female who at "one year of age" was vaccinated with varicella virus vaccine live. Subsequently the patient developed a rash. The patient sought unspecified medical attention. The patient required no treatment for the symptoms. There was no product quality complaint involved. Additional information has been requested.
She went to her doctor, got her vaccine and had swelling of her arm, don't recall exactly about the flare up of her joints due to her RA.  A week later she woke up with a rash, could see where the injection site was, went to her chest, under her armpit, across the chest, all the way to the other side and up her neck.  The rash was itchy in nature, red and possibly warm to touch.  Over the weekend is when this happened and when she has a flare up her rheumatologist prescribes Prednisone which she got.  She then called her doctor after the rash appeared and saw him who prescribed a stronger cortisone cream than the rheumatologist suggested.   She went to the UC as she was having some things happening with her eyes, and as she started taking the prednisone she could not sleep.  Was listening to messages on line and tired and in and out, and was listening to a message online and felt like a feeling all of a sudden, has had having visions of the Lord, like her eyes were open and the visions kept going and going and could not shut them off.   Her eyesight  has been affected.  It did finally stop, but does not know if it was associated from the vaccine or other things.  When she looks at a light colored floor or a light colored counter but has millions of little red pinpoint specks that are covering things.  She did go to an eye specialist, Ophthalmologist and she said it was spots.  She has not gone to look into it further, but she plans to.  The rash went away, but it took take over a month for it to alleviate.    She was having some fluid swelling in her legs and feet, since then she has had some swelling but not as much as before.  He said it was her capillaries as in the morning her feet were not swollen, but as the day goes on she has it.  She also wakes up with redness in her feet now which she does not recall having prior to the vaccine.  The redness is on the lower portion of her legs.
Headache; Fever; Body aches; Swollen lymph node; This is a spontaneous report from a contactable consumer. This is report 1 of 2. This 54-Year-old female consumer (patient) reported. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: FC3182 or FC318Z but thinks it is a 2 not a Z), dose 2 via an unspecified route of administration, administered in right arm on 23Aug2021 14:00 (at the age of 54-years-old) as a single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0176) via an unspecified route of administration, administered in right arm on 02Aug2021 at around 10 something in the morning (at the age of 54-years-old) as a single dose for covid-19 immunization. Medical history included none. When she had shingles shot, it did the same thing and gave her fever and chills. She does not have further details to provide for shingles shot last dose she received in Jan 2021. She clarifies she does not have chills right now after the covid vaccine. The patient's medical history and concomitant medications were not reported. She just takes her medication every day. She does not think they are relevant to add. The patient experienced headache, fever, body aches and underneath her jaw she guess the lymph nodes there are swollen. The patient decline any treatment. No emergency room and physician office. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101100496 same reporter/product/event, different patient
Severe muscle and joint pain, fatigue, low grade fever for 2 days.  Loss of appetite. Treatment Tylenol 650 mg and Ibuprofen 400 mg. Symptoms resolver after 2 days
This case was reported by a pharmacist via call center representative and described the occurrence of muscle soreness in a 69-year-old male patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 6th August 2018, the patient received SHINGRIX (intramuscular) 50 ug. On 6th August 2018, less than a day after receiving SHINGRIX, the patient experienced muscle soreness and influenza-like symptoms. On 8th August 2018, the patient experienced rash and injection site erythema. On an unknown date, the outcome of the muscle soreness and influenza-like symptoms were recovered/resolved and the outcome of the rash and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the muscle soreness, rash, injection site erythema and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient experienced muscle soreness and flu like symptoms on the first and second day, but they had resolved. On 8th August 2018, the patient developed a rash around his neck, and on his stomach and chest. He also developed redness around the injection site and inside his elbow.
Chills; fever at 101.5 F; Body aches; This is a spontaneous report from a contactable consumer. A non-pregnant 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 01Mar2021 at 16:30 (Batch/Lot number was not reported; at the age of 40 years old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 (diagnosed with COVID in December of unspecified year) and no thyroid (ongoing) which is controlled by SYNTHROID. No known allergies. Concomitant medication included ongoing levothyroxine sodium (SYNTHROID) for no thyroid. No other vaccine in four weeks. On 02Mar2021 at 04:00 am, the patient experienced chills, fever at 101.5 F, and body aches. This is the same reaction she had when she was diagnosed with COVID in December (unspecified year). It was unknown if the patient received treatment for the events. The patient has not been tested for COVID post vaccination. The patient has not yet recovered from the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Immediately, post vax and finger stick for hemoglobin, pt fell off chair and was stiff, according to father, who picked her up. The child was initially alert, pale and quiet. She then proceeded to sleep for 2 1/2 hours, able to be aroused but quickly back to asleep. Pt transferred to the hospital and admitted for observation. Pt discharged the next day.
(L) upper arm redness, warmth, tenderness and swelling - tx'd w/ ZYRTEC and MEDROL dose pak.
pt recv vax 9SEP97 & devel rash @ inj site;allerg event macular papular rash torso & extremities;BP 165/112;
Chills for approximately 4 hours.  Fatigued for approximately 6 hours. Body aches for approximately 12 hours.  Slight headache-took Ibuprofen.
I received the Covid vaccine on 1/28/21- and had been completely healthy.  But 5 days later on 2/2/2021- the LEFT side of my face was no longer moving the same as the right side of my face.  I went to the mirror and noticed that I couldn't smile, couldn't raise my eyebrows , couldn't close my eyes shut... and realized that i was experiencing a BELLS PALSY.  I called the doctor and got a prescription for Prednisone and Valacyclovir. that same day.  The next day 2/3/21.. I got in to see the neurologist who confirmed the diagnosis and asked that I get an MRI of the brain and start physical therapy on my face due to facial memory loss-- which I did the next day 2/4/2021.  The hardest part of this facial paralysis has been my eye- which continuously runs and burns- so much so that the  neurologist sent me to a cornea specialist- whom I saw the next day on 2/5/21. I was instructed to tape the eye down to prevent severe dry eye and allow eye to rest. I have been going to PT now twice a week since then, taping my left eye and completing massage exercises  at home as i was told.
12 year old son received Menactra twice in a year; Initial information received on 20-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 12 years old male patient who experienced 12 year old son received menactra twice in a year, while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported.  It was of actual medication error due to extra dose administered..  No adverse event was reported.  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.
Several minutes after Td & Hep A vaccinations, the patient fainted for several seconds. Before falling to the floor, she experienced lightheadness and dizziness. She recovered without any treatment.
Information has been received from a healthcare worker concerning a 12 year old female who was vaccinated with her second dose of Gardasil (lot number not provided).  Concomitant therapy included MENACTRA.  Subsequently the patient experienced swelling at injection site, rash, fever and shortness of breath.  The patient was reported to be recovering.  No further information is available.
High heart rate; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller stated she received the first dose of the Pfizer Covid 19 vaccine and she was experiencing now a high heart rate. She was asking to continue with the second dose or not. The patient underwent lab tests and procedures which included heart rate was high (unit not provided). The outcome of event was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
5-19-17 - called clinic and states arm red and swollen. Also states more sore and symptoms more prominent than last CPX vaccine. Advised to ice, can see if needed. Declined. 5-22-17 call to patient - symptoms resolved.
Serum Sickness (urticarial rash and fever and joint pain and swelling). Treatment: Prednisolone and Cetirizine.
Pt reported syncope and collapse on 6.13.21, onset of LEFT leg swelling, chest pain and dizziness 6.17.21. Pt was diagnosed with extensive DVT of LLE and bilateral PE with significant clot burden on 6.22.21