chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness at injection site; feels cold; chills; muscle pain; joint pain; headache; feels like skin is burning; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 5th November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, feeling cold, chills, muscle pain, joint pain, headache and burning sensation skin. On an unknown date, the outcome of the injection site pain, feeling cold, chills, muscle pain, joint pain, headache and burning sensation skin were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, feeling cold, chills, muscle pain, joint pain, headache and burning sensation skin to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid and had injection site pain, feeling cold, chills, muscle pain, joint pain, headache and burning sensation. The patient planned to follow up with her physician on an unknown date. The reporter consented to follow up.
A non-serious spontaneous report of splashed FLUMIST in 6 years-old eye was received from a nurse concerning a six-year-old male. The FLUMIST inadvertently splashed in the six year-old patient. The nurse rinsed patient's eye with water. Post rinsing, patient was fine and had no symptoms. On 27-Oct-2010, the patient received FLUMIST. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
sharp lower back pain; pain going down his right leg; feels almost like a pinched nerve; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283 and expiry date: unknown), via an unspecified route of administration on the left arm, on 13Jan2021 11:00 at a single dose for COVID-19 immunization. There were no medical histories. The patient's concomitant medications were not reported. Patient had been having side effects such as sharp lower back pain going down his right leg on late thursday (14Jan2021) afternoon, but probably the morning of 15Jan2021, which he never had before. It feels almost like a pinched nerve, but hasn't done anything to exert himself since he received the COVID-19 Vaccine. He did not cause this pain himself and wanted to know if anybody else has reported this. Outcome of the event was unknown.
I had a VERY light 2 day period in April and May following my second vaccine June I did not have a period at all. July was late, and light. Now it's August and I've been menstruating for three weeks straight. Heavily for 2 weeks.
I did not have an adverse reaction to the booster but I tested positive for COVID-19 March 2022. I was sick for five days. My symptoms where sore throat, tired and achy. I took Advil for the headache and achy. Also I used a throat spray (don't remember the name) because my throat hurt so bad.
given an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 23-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 542NY, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th September 2021, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On 13th September 2021, unknown after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that, a patient had been given an expired dose of Flulaval, which led to expired vaccine used. The reporter mentioned that, the patient was male but seemed to be trans so upon follow-up the gender of the patient might change. The reporter consented to follow up  by email.
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the shot did not keep one from getting the shingles and added that, if someone once had chicken pox, they would not get a severe case of shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.   .; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179078:same reporter, reporter's case
She got her vaccine, she was fine with the shot and did not feel anything.  She did her errands and after 24 hours that she started feeling miserable and started to feel hot and had 102.4 fever, which is unusual for her.  She was so  miserable that she did not want to take anything, and feeling feverish, chills and perspiration and took a Anacin, which lessened the fever a little bit.  It went back up and then checked it later is was 101.4, and then she continued to take the Anacin to see if it would go away and then it would peak again.  She has not rechecked it again.  She feels miserable, has very bad pain on the injection site, tender, swelling and itching.  It was realy itchy for the first 24-48 hours.  The priprimary feeling that makes her feel bad is the fever.  She never gets high fevers, chills and perspiring of her entire body, arms, legs, behind the knees.  She also has great fatigue and body aches.  The only pain is on the upper right arm where the shot was.  She has not contacted her doctor.  She has problems with her pancrease and her heart and was told if she has problems with any of that to go to the hospital, and she was considering to do that.  She decided to report it in the event she had to go to the hospital.    She had the over 65 Fluzone vaccine over 30 days ago with no reactions.
There wasn't actually an adverse event but I didn't see an option for a form for an administration error. We had only processed one of his 2 shots through the computer system so at first it seemed like he had gotten an extra vaccine. However we discovered he had wanted both vaccines and we just hadn't processed the flu shot through the computer. I am sorry if this isn't something that needs to be reported to you but my boss asked me to.
HEADACHE; BLACK STOOL; NAUSEA; 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 concurrent conditions included non smoker, and other pre-existing medical conditions included the patient did not had no known drug allergies. The caller did not wish to provide medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on right arm on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced black stool. On 14-MAR-2021, the subject experienced nausea. On 15-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and headache on MAR-2021, and had not recovered from black stool. This report was non-serious.
Significant energy drop; Red arm 4-5 days later; (Reference number: MOD21-116875   ) on 29-Jun-2021. The most recent information was received on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Significant energy drop) and VACCINATION SITE ERYTHEMA (Red arm 4-5 days later) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery. Concomitant products included CITALOPRAM from 2011 to an unknown date, ATORVASTATIN CALCIUM (LIPITOR) from 2011 to an unknown date and BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (ZIAC [BISOPROLOL FUMARATE;HYDROCHLOROTHIAZIDE]) from 2011 to an unknown date for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Significant energy drop) and VACCINATION SITE ERYTHEMA (Red arm 4-5 days later). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, ASTHENIA (Significant energy drop) and VACCINATION SITE ERYTHEMA (Red arm 4-5 days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-240672 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up information was  received and event was added. On 09-Aug-2021: Follow-up received contains additional information of patient demographics (height, weight and race), updated lot number, added route of administration from unknown to oral and start date of concomitant products.
Four weeks ago, the tip of my right thumb went numb. Over the course of the next week the numbness extended to my entire hand and patches of numbness on my arm. The numbness spread to my left hand and arm and to my feet as well.  At this point my right arm is numb 24/7. The numbness has affected my gait. I had a previous knee injury that has flared up. My dr. put me on a heavy inflammatory steroid which didn't help the numbness but did help the knee pain while I was taking it.
pt recv vax;that noc,exp insomnia,irritability & n;felt inability to sleep was disabling;in f/u:sleeplessness has improved;pt's sx were attributed to a viral epidemic that was going around at time of vax;
Patient said a few days after vaccine, she noticed swelling at the site of the injection, which then over time started to move down her arm. On Sunday, patient went to Urgent Care where the MD diagnosed infection in the lymph nodes. Patient said she was prescribed antibiotics since Sunday and the swelling and symptoms have started to improve as of today, 5/9/18.
Edema, erythema 7"x5" area around injection site (SC area). S/S started 10/2/07.
Headache, muscle pain, pain in the arm of the injection, chills, internal fever, nasal congestion, eyes pain.
woke up cold, very cold; not well; Inappropriate schedule of vaccine administered; confused in my  head; arm is hurting/pain in arm; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (confused in my  head), NASOPHARYNGITIS (woke up cold, very cold), MALAISE (not well), VACCINATION SITE PAIN (arm is hurting/pain in arm) and PYREXIA (fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced CONFUSIONAL STATE (confused in my  head), VACCINATION SITE PAIN (arm is hurting/pain in arm), PYREXIA (fever) and HEADACHE (headache). On 28-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 29-Oct-2021, the patient experienced NASOPHARYNGITIS (woke up cold, very cold) and MALAISE (not well). On 28-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, CONFUSIONAL STATE (confused in my  head), NASOPHARYNGITIS (woke up cold, very cold), MALAISE (not well), VACCINATION SITE PAIN (arm is hurting/pain in arm), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: 98.7 (High) 98.7.         Patient reports her first dose was Johnson & Johnson (JNJ) - Lot # 1805029 done on 22March2021.
One week after first vaccination, my injection site became reddened to a 2.5? x 3? red patch on my arm. Warm, itchy at times and swollen
Chills and rigors continuing at almost 3 weeks. Temp measured at time of chills and rigors has been no less than 100.9. Last measured temp 101.3. Highest measured temp 101.8.
I noticed that my tongue felt prickly, as if it had been scalded even though it hadn?t.  My tongue did not look any different and I could still taste normally.  The sensation was relieved while eating but returned between meals.  I believe it lasted at least two weeks.  I called my doctor to tell her about this sometime >10 days after it started?since I already had an appointment scheduled in the next few weeks, we agreed to just monitor it and address it at that appointment.  By the time I saw my doctor, the sensation had resolved and my tongue felt normal again.
Burn like skin abrasion on left chest area (upper breast, near shoulder) developed on Wednesday mid-day (a few days after receiving vaccine).
EE states jaw tightness, tongue swelling, horse voice, had to keep clearing throat, tachycardia- employee was advised ER visit is necessary for this. Employee seen at local ER treated with Benadryl and Oral steroids, released to home.  Diagnosed with angioedema.
Information has been received from a registered nurse concerning a 5 year old female who on approximately 09/30/2001 was vaccinated with a dose of varicella vaccine. In approximately October 2001, the pt had break thru chicken pox with approximately 20 lesions. Additional info has been requested.
The registered nurse reported that on unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M003659, expiration date 20-SEP-2017, dose and route unknown), PEDVAXHIB (lot # L051124, expiration date 14-OCT-2018, dose and route unknown, captured in 1609USA010855) and M-M-R II (lot # L036851, expiration date 23-SEP-2017, dose and route unknown, captured in 1607USA008489). The temperature excursion information included the highest temperature of 53.2 degrees Fahrenheit for 30 minutes. No adverse effects were reported. Follow up information has been received from the registered nurse on 20-SEP-2016. She said that no patients who received the improperly stored vaccines experienced any adverse symptoms. She said she had no additional information. This is one of the several report received from the same reporter. This report refer to the improperly stored GARDASIL 9. Additional information has been requested. Reporter and narrative were updated.
p/vax pt exp red painless rash consisting of rings + papules at site of inj; rash ongoing;no other sx noticed by parent;afeb;mom will watch for blisters, poss bloodwork could be ordered;
Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Injection site pain).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.
I experienced two of my toes left side swelled up next to my baby toe and it went down the next day a day or two later my left side finger swelled up  with pain and I cant bend my finger and pain in my shoulder area where she shot had taken place across my chess down across my stomach  down to my lower right side area to my  hip area and few days later my thumb stated inching with pain and there are tow little bumps  on my thumb area
Severe headache 7/4, syncope 7/5, PCP visit CT head ordered.  Hyponatremia  (124) 7/9.  ER visit 7/9 CT head 7/9 (no acute changes) IV Fluid NS to replace sodium/fluid bolus/pain medication.  Slight cough with purulent sputum 7/13. Two home covid tests positive. Virtual PCP visit 7/13 prednisone/zithromax prescribed.  Headache/fatigue 2 weeks. Headache relief while on prednisone then returned.  7/29 Neurologist appointment MRI brain with venogram to rule out embolic event from covid. Study completed 8/19 results pending
A report has been received from a Health Professional concerning a 5 year old. Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). The patient's medical history, concurrent diseases and concomitant medications were not reported. FLUMIST QUADRIVALENT (INTRANASAL) started on 26-Dec-2013. The patient experienced EXPIRED FLUMIST QUADRIVALENT ADMINISTERED which started on 26-Dec-2013. The patient used EXPIRED FLUMIST QUADRIVALENT which started on 26-Dec-2013. The outcome of the event of EXPIRED FLUMIST QUADRIVALENT ADMINISTERED is unknown. The report was considered to be non-serious by the reporter.
MMR was 24 hours expired but drawn up and given.  No adverse event reported per patient.
I had the Pfizer vaccine on Friday, March 21st. An hour after getting the vaccine I could not walk. I could move my feet and legs but couldn?t walk until the next day.  In addition I could understand what people were asking me but couldn?t find the words to answer their questions properly.
Cellulitis of right thigh. Started on antibiotics - f/u 24 hours.
patient received RotaTeq vaccine 7/22/08.  Diarrhea started 7/24/08.  4 or 5 diarrhea stools first 2 days then more than 20 stools per day.  patient admitted to hospital for fluids. 8/5/08-records received for DOS 7/28-7/31/08-DC DX-Diarrhea. Dehydration. Milk Protein Allergy. Diarhea began on 7/24/08-4-5 per day greenish in color, increasing over past 24 hours. Hungry, eating frequently. Cottage chees like stools. Half pound weight loss. No fever.  Admitted for hydration.
Pt reported not feeling; tachycardia @ 110 approximately 20 mins after vaccine. sweaty, BP WNL 15L O2 given to pt along w/ 10 mg cetirizine and 25 mg diphenhydramine
48 hrs after DPT got sore arm, headache, next day got chills with fever to 101. Headache persisted 1 wk and nausea.
Patient is a 14-year-old male who presented to Hospital ED with chest pain after having Covid vaccine yesterday (6/8/21). EKG shows no evidence Brugada, ACS, pericarditis, arrhythmia, ectopy, SVT. He was given IV fluid, Toradol and reassessed and he felt significantly improved and was chest pain-free at time of discharge.
body aches/body is aching/sore/all his body very painful; couldn't breath; itchiness; light headed feeling; feeling weak/weakness; can't walk; redness; joint pain; vomiting; nausea; hives all over his body; shot area was very painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches/body is aching/sore/all his body very painful), DYSPNOEA (couldn't breath), PRURITUS (itchiness), DIZZINESS (light headed feeling) and ASTHENIA (feeling weak/weakness) in a 34-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches/body is aching/sore/all his body very painful), DYSPNOEA (couldn't breath), PRURITUS (itchiness), DIZZINESS (light headed feeling), ASTHENIA (feeling weak/weakness), GAIT DISTURBANCE (can't walk), ERYTHEMA (redness), ARTHRALGIA (joint pain), VOMITING (vomiting), NAUSEA (nausea), URTICARIA (hives all over his body) and VACCINATION SITE PAIN (shot area was very painful). At the time of the report, PAIN (body aches/body is aching/sore/all his body very painful), DYSPNOEA (couldn't breath), PRURITUS (itchiness), DIZZINESS (light headed feeling), ASTHENIA (feeling weak/weakness), GAIT DISTURBANCE (can't walk), ERYTHEMA (redness), ARTHRALGIA (joint pain), VOMITING (vomiting), NAUSEA (nausea), URTICARIA (hives all over his body) and VACCINATION SITE PAIN (shot area was very painful) had not resolved.            No allergies were reported. No concomitant medication information was provided. It was reported that the patient experienced following vaccination: hives all over his body, body aches until now, on last Sunday went to the ER. The second day after vaccination his shot area was very painful, he complained that he was so weak and after a couple of days he had hives and then he went to the ER.  The symptoms were the same and he had not been going to work for almost 2 weeks. For treatment, patient received allergy medication after 6 hours the hives come out again.  Patient has not had COVID + test or diagnosis. Patient did not experience similar event in past. Reporter did not know how many doses the patient had received.
really tired; a little headachy; soreness at the injection site with both injections; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (really tired), HEADACHE (a little headachy) and VACCINATION SITE PAIN (soreness at the injection site with both injections) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced FATIGUE (really tired) and HEADACHE (a little headachy). In 2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site with both injections). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 23-Jan-2021, FATIGUE (really tired) and HEADACHE (a little headachy) had resolved. At the time of the report, VACCINATION SITE PAIN (soreness at the injection site with both injections) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not reported.   This case was linked to MOD-2021-373097 (Patient Link).