chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness at injection site; swelling at injection site / swelling; warm to the touch / warmness at injection site; fever; sore arm / arm soreness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 249DB, expiry date 8th November 2021) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 12th September 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site warmth, fever and pain in arm. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth, fever and pain in arm were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, fever and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm. The reporter reported that one day after receiving dose 1 of Shingrix, the patient experienced redness at injection, warmness at injection site, arm pain, arm soreness, fever, and swelling. The patient went to urgent care and was given unspecified medications. The symptoms were improving. The reporter consented to follow up.
Cough,runny nose,loss of smell,sore throat,nasal congestion,headache,fatigue,loss of taste
Patient was administered vaccines. Immediately after began holding breath and eyes rolled back, appeared to be having a seizure. Child was observed during seizure which lasted about 1 min then Dr. was called to check him. Per Dr. heart (+) lungs sound good and perfusion good. Patient was observed in clinic for 15 min after seizure. No further reaction noted.
Patient received vaccine at a pharmacy on 7/25, and came into clinic on 7/27. Patient states that on 7/25 she had fever and redness/swelling. Patient felt like her arm was getting bigger.  Patient stated she treated symptoms at home with over the counter medications. Afebrile at appointment, but noticeable redness and swelling at injection site. Left arm with roughly 8 cm x 8 cm erythema, warmth, induration but no drainage. Treated for cellulitis - and started on cephalexin.
Information has been received from a physician concerning a 6 month old patient who on 17-AUG-2009 was vaccinated with the first and only dose of ROTATEQ.  It was reported that the patient received the vaccine later than the recommended age.  No adverse effect reported.  Follow up information was received from a physician concerning a 28.5 week old (previously) reported as 6 month old ) male infant who in August 2009 was vaccinated with a dose of ROTATEQ (Lot # 660269/0148X), valid for measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD).  It was reported that the patient received oral vaccine at 6 month check up under the assumption that he had received the 2 and 4 month doses at his previous physician's office.  It was reported that when immunization records were received, there was no 2 or 4 month doses given.  At the time of the report the patient was 2 weeks post-administration of ROTATEQ and has had no adverse reactions.  No further information is available.
Patient received Pfizer COVID vaccine on 7/22/21 and 8/23/21 in our facility, Medical Center. During 2nd dose administration on 8/23/21, patient only received 0.2mL (instead of 0.3mL). Per CDC guideline, no additional dose is needed if given volume > 50% of recommended dose. No adverse event occurred with the patient. This is being reported as an administration error.
patient was given a third dose of Menquadfi (with no reported adverse event); patient was given a third dose of MENQUADFI instead of Bexsero (with no reported adverse event); Initial information received on 31-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16-year-old male patient was given a third dose of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [Menquadfi] (with no reported adverse event) and patient was given a third dose of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [Menquadfi] instead of Bexsero.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 24-Jul-2023, the patient received a dose 3 of 0.5 ml total dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (strength: unknown) (lot: U75968B, expiry date: 14-Mar-2025) via intramuscular route in the left deltoid for Immunization and unknown dose of suspect BEXSERO not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for immunization.  On 24-JUL-2023 the patient was given a third dose of menquadfi (with no reported adverse event) (extra dose administered) and patient was given a third dose of menquadfi instead of bexsero (with no reported adverse event) (wrong product administered) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE and (unknown latency) following the administration of BEXSERO.  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) and MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) was not applicable.  Outcome: Unknown.    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 the 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.
In August 2000 (previously reported as the beginning of September 2000) the patient developed a full blown classic case of chickenpox with greater than 50 pox and "all the symptoms that go with chickenpox". It was noted that the patient was covered with varicella spots. The nurse noted it was the same course as if the patient had not received the vaccine, greater than 50 spots, one week to break out, and two weeks to scab up and recover. The patient recovered approximately August, 2000. The patient was seen in the doctor's office on 09/22/2000 and was noted to have scabbing and scarring of pox. No further information is available.
Two days after receiving her Moderna booster (and 11 days after receiving influenza vaccine), pt developed persistent fevers and chills, with nightly fevers to approx 100.7.  Also developed malaise and arthralgias.  Arthralgias mostly affected wrists but also affected hands, neck, and back, w/ associated weakness in her upper extremities.  The arthralgias were severe and made it hard to use her hands/wrists, e.g., to open a bottle.  Extensive evaluation was undertaken to check for infectious and rheumatologic causes.  A UTI was discovered and pt was treated for this, with brief improvement in the fever, but then fever and severe arthralgias returned while still on appropriate UTI treatment.  Extensive lab eval as below.  Ultimately treated w/ prednisone 10 mg daily with prompt drastic improvement in arthralgias.  We last touched base with pt one day after prednisone was started, but have not gotten update in past 9 days.
Resting heartbeat/rate increases from seventies to around 90, with max between 130-140 (no chest pain; not short of breath). Occurred one month after the second dose. No sign of ease 6 months after. It can happen anytime during day and night.
severe burning in my chest and my intestine; severe burning in my chest and my intestine; Vertigo; Headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 71-years-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number EW0176, expiration date unspecified), via an unspecified route of administration, administered in arm right on 07May2021 as single dose for covid-19 immunization (71 year when vaccinated) at a pharmacy. Medical history included osteoporosis from an unknown date. The patient's concomitant medications were not reported. On 07May2021, the patient experienced slight headache few hours after the shot. On an unknown date couple of days later the patient had severe burning in my chest and my intestine and had a really severe headache and had vertigo pretty bad. The patient reports of going to doctor tomorrow and wanted to have some Prednisone to calm all this down also wanted to make sure it will not be going to interfere if the patient decide to take the second shot in the next 3weeks. I has been a week since the first dose and was concerned because patient is not well. The patient was is treated with Tylenol 500mg sometime take 1 or 2. The outcome of the events was reported as unknown at the time of report.   No follow-up attempts are possible. No further information is expected.
overly dehydrated; high blood pressure/ blood pressure was 178/122; could not sleep entirely/she was in a semi-sleep state/having insomnia feeling like really bad; could not move or open her eyes; her head felt like exploding; her heart pounding/ heart rate 102; extreme fatigue; This is a spontaneous report from a contactable consumer (the patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 12Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization, and experienced: arm soreness, nausea, and headache, on an unspecified date. After 1 hour 30 minutes of getting the second dose on 12Feb2021, the patient felt an extreme fatigue and went to sleep. She could not sleep entirely (from an unspecified date) and woke up and went to the bathroom several times after midnight and she tried to wake up at 4 am, but she was in a semi-sleep state half aware and could not move or open her eyes no matter how hard she tried.  She described this state as she couldn't move and having insomnia feeling like really bad. When she managed to pull this up, she took her pulse and blood pressure and she was having high blood pressure, her head felt like exploding and also her heart pounding. Her blood pressure was 178/122 and her heart rate 102. She stated that her husband tried to call Pfizer that moment, but they could not get a hold of someone after 30 minutes, so they contacted 911. She was taken to the hospital, and her chest X-ray and EKG were normal (to discard a heart attack). Then they noted that she was overly dehydrated, so they prepared some IV (intravenous) solution for her. The clinical outcome of the events was unknown.  Information on Lot /Batch Number has been requested.
Erythema, induration, warmth, edema around site of injection and edema + mild erythema extending to top of shoulder to elbow.
Redness around vax site within 15 minutes grew to 3 inches long by 1 inch wide, warm, stayed like that for 20 days, visited doctor several times but was not advised any treatment. After 20 days area was 2 inches long by 12 wide.
Flu like symptoms; late period; dandruff; dry scalp; fever; increased heart rate; Chills; Headache; Leg ached; Arm ached; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache), PAIN IN EXTREMITY (Leg ached), MYALGIA (Arm ached) and INFLUENZA LIKE ILLNESS (Flu like symptoms   ) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), PAIN IN EXTREMITY (Leg ached) and MYALGIA (Arm ached). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms   ), MENSTRUATION DELAYED (late period   ), DANDRUFF (dandruff   ), DRY SKIN (dry scalp   ), PYREXIA (fever   ) and TACHYCARDIA (increased heart rate). At the time of the report, CHILLS (Chills), HEADACHE (Headache), MYALGIA (Arm ached), INFLUENZA LIKE ILLNESS (Flu like symptoms   ), MENSTRUATION DELAYED (late period   ), DRY SKIN (dry scalp   ), PYREXIA (fever   ) and TACHYCARDIA (increased heart rate) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-202148.
Immunizations given 3/22/07 approx 8:30am mom reported mild fever at MN 3/23/07 - gave infant Tylenol drops. Found infant dead in crib 3/23/07 at 7:30AM!  7/3/07 Received Autopsy Report which reveals COD as Undetermined & manner of Death as Undetermined.  Final anatomic diagnoses were: clean & apparently well care for; no evidence of trauma or injury; lung & thymus petechiae; and focal mild acute bronchopneumonia of right lung.
Pain in arm continuing 4 weeks since shot. No hardness, warmth, redness or swelling. Can lift should and has range of motion. Pain extends down towards hand. Pain is relieved by ibuprofen.
This spontaneous report was received from a register nurse concerning a 2 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. In August 2014, the patient was vaccinated with the second dose of M-M-R II (dose, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. Nurse practitioner reported that a patient was administered the first dose of M-M-R II in January 2014 and the second dose of M-M-R II early in August 2014. No adverse events were reported. Additional information has been requested.
This spontaneous report as received from a physician refers to unspecified number of patients. On unknown dates the patients was vaccinated with a dose of GARDASIL (dose, route, lot number unknown). Physician reported that unspecified number of patients experienced syncope after receiving GARDASIL. The outcome of syncope was unknown. Additional information has been requested.
This also happened last year but while we suspected it was the vaccine, we couldn't prove it; we thought maybe it was a fluke.  He had an EEG and follow-up with the pediatrician...I am not sure if they ever reported this because I think nobody believed it was related to the vaccine.   Yesterday patient got the serogroup B meningococcal vaccine (his second in the series) and shortly after midnight he started this violent generalized myoclonus/seizure-like activity.   This is the exact same thing that happened last year when he got the first dose of the vaccination (I witnessed both events).   Below is what occurred:   0013-0018 7/26 affecting arms/thighs/chest...able to talk and appropriate mentation, like an uncontrollable, violent shivering in waves (baseline shaking was like somebody really cold but then it would peak to really extreme shivering type activity and subside to it?s baseline and this repeated the pattern several times... weird... just like last time but it didn?t last as long).  O018-23 both lower legs twitching frequently but majority of the myoclonus had subsided.  0024- 0026 mild upper body/ right thigh ?shivering-like? activity, still completely conscious and talking to me.    Afterwards Body felt really worn out but he didn?t seem post-ictal mentally; he said it felt like he just ran a 5K race.  He drank some gatorade and laid there lightly sleeping for an hour or so.
2/17/2021- 02/18/2021: Chills, Headache, fever, gait instability, burning feeling and pain in the injection site.   2/24/2021 Strong throat pain, nasal drip, taste loss, chills, weakness.
redness of entire upper arm, 2cm blister at site of injection, dizziness, tactile fevers, nausea, diarrhea
Information has been received from a healthcare professional concerning a 24 year old female who on 04-APR-2007 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# 658563/1063U), 0.5mL IM for prophylaxis. Concomitant therapy included desogestrel/ethinyl estradiol (MIRCETTE). On an unspecified date, the patient received her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not reported). On 22-OCT-2007 the patient received her third dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# not reported). On 23-OCT-2007 the patient experienced dizziness and hot and cold sweats. Medical attention was sought. The patient's dizziness and hot and cold sweats persisted. The product quality complaint unit was not involved. Additional information has been requested.
No adverse event; patient received an expired Monovalent first dose of Moderna COVID-19 vaccine beyond Expiry Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired Monovalent first dose of Moderna COVID-19 vaccine beyond Expiry Date) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. 013B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired Monovalent first dose of Moderna COVID-19 vaccine beyond Expiry Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received an expired Monovalent first dose of Moderna COVID-19 vaccine beyond Expiry Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient received an expired Monovalent first dose of Moderna COVID-19 vaccine beyond Expiry Date).    Concomitant drugs were not reported.  It was reported that the monovalent individual vial of 5.5 ml red cap was initially stored in refrigerator on 01-Dec-2022. The vial did not undergo any temperature excursion.  Treatment medications were not provided.
On 11/26/20221 in the middle of the night around 2:00AM -3:00AM I noticed that back of my hand felt pain, left side of my face were numb. The area where I got the shot was really hurting. It lasted for few days, both of my hands were shaking. My blood pressure was very high, they send me to neurologist to check for Parkinson and for stroke. The MRI didn't show anything. I still have tremors on my hand. I did not have any of them before my vaccine. I didn't take any pain killers after few days it went away. Vaccinations site was very swollen. I was in bed for 3 days. Both arms are still shaking as of now.
Patient received flu vaccine on 10/08/2008 in left deltoid. On 10/9/2008 her left upper arm was very sore. Extending over her left collarbone. She also noticed a pea-size mobile "bump" above her left collarbone. She was evaluated 10/10/08 in our office - Temp 97.7? Placed on IBUPROFEN 600 mg three times daily. Ice/heat rotating onto (L) deltoid. 10/15/08 rechecked in our office - (L) deltoid not tender, but still with single soft, non tender mobile (L) supraclavicular lymph node.
1)Local reaction at injection site (redness, induration) measuring 2x1cm on right thigh, initially evident 24 hours post injection, increased size by 48 hours and then began to resolve (less red, still significant induration). The Dtap and Pneumococcal vaccine was given in this leg. No additional treatment was required.  2) Diarrheal illness following administration of second dose of rotatec (rotavirus vaccine). Symptoms began 48 hours post vaccination and were accompanied by severe vomiting x 12 hours.  The vomiting required adjusting the volume and frequency of feedings to avoid dehydration. Diarrhea continues presently and we are 3 days into the symptoms; vaccine given 11/30/07 3) Diarrheal illness following the first administration of rota virus vaccine- occurred 5 days post administration and lasted 5 days; my son then developed an ear infection and perforated his tympanic membrane requiring 10 days of ciprodex drops and 10 days of amoxicillin
To be filled in or corrected by doctor. May have CovID breakthru Initially can't remember cause(s) that brought to needing medical attention.
pain and swelling in armpit, started as mild annoyance around 11am on 04/03/2021 and then by about 12:30pm the same day the pain got worse.  Pain was constant till about Tuesday, then Wednesday was minimal.  Armpit hurt to the touch and was super sensitive.
MONDAY MARCH 8, 2021 , had itching and hives on back, thighs, legs , arms and stomach. They would come and go. On Tuesday it contined and the bumps on legs and thighs were raised. Went to clinic, where I was given a prednisone shot and it helped. All hives cleared within 24 hours. Today March 12th saw my regular doctor and he suggested I report incident.  To see if 2nd dose should be administered on schedule.
Fever, chills, coughing, muscle spasms, loss of appetite, dizziness, confusion, headache, disorientation, extreme body aches, thick stringy phlegm, extreme fatigue, extreme weakness.
I have some brain, some memory issues; I have some brain, some memory issues; This is a spontaneous report form a Pfizer-sponsored program from a contactable consumer (patient)   A 59-years-old patient of an unspecified gender received eletriptan HBr (RELPAX), route of administration, start and stop date, batch/lot number and dose were not reported for migraine; bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE ), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as an unspecified dose for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient stated "I have some brain, some memory issues on an unspecified date with outcome of unknown.  The action taken in response to the event(s) for eletriptan hbr was unknown .  No follow up attempts are needed. No further information is expected.
Erythema and edema 2 inch center spread to aprox 5-6 inches.
Received DTAP and Prevnar on 11/11/2003 about 16:30.  Parent states broke out in rash about 20:00 that evening.  Had papules over whole body and itching.  Prescribed Benadryl 12.5 mg/5cc.  4cc hD prn and take Aveeno Baths, per MD.
16 YO HAD 1ST DOSE OF MODERNA 3/17/21, RETURNED FOR 2ND DOSE. MED CONSULTATION DONE REGARDING OFF LABEL USE. MOTHER SIGNED CONSENT. PT GOT 2ND DOSE MODERNA.
I received the flu vaccine and about 15 minutes after I developed a rash on my entire left arm including my hands. The rash looks exactly the same when I had an anaphylaxis reaction to polyisoprene. I?m not sure if the syringe for the vaccine contained polyisoprene. I took 2 Benadryl tablets and did not have to use my epi pen.  All my symptoms have resolved except for the rash.