chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm sore to touch; painful at injection site, 2 days; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th October 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In October 2022, less than a week after receiving Shingrix, the patient experienced pain in arm. On 18th October 2022, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-Oct-2022 Reporter's comment: This case was self-reported by the patient. The patient received first Shingrix on left arm.  The patient reported that arm was very painful at the injection site for 2 days.  The patient reported left arm was still sore to the touch.  The reporter did not consent to follow-up. Less than a day, the patient experienced injection site pain.
2cm morbilliform/urticarial rash started evening of injection.  Rash progressed over next 3 weeks to involve the entire left arm, forearm with slight extenion superior into axilla and chest.  Week 3.5 skin on other parts of body (behind knees, groin) was pruritic with small but no progressiv rash.     Treated with oral antihistamines, topical anesthetic lotion and topical steroids.  Rash persists at week 4
shortness of breath, dyspnea on exertion that started after 2nd vaccine, found to have pulmonary embolism 2 weeks later
Localized redness and swelling with tenderness over injection site at 3rd after day with illness lasting for at least 6 days. A follow up report received 5/24/2002 adds that reaction was at DTaP site.
The wrong patient was given the vaccine during a school vaccine clinic. Patient did not have any adverse reactions.
I tested positive for COVID-19 on 5/25/23. I had fever, sore throat, cough, nausea, chills, headache, fatigue, shortness of breath and body aches. I didn't go to the doctor at the time and just took Tylenol for the fever. I ended up going to the Emergency Room, but they did not give me medication because of my Kidney problems. They offered Remdesivir, but I declined that too. This has lasted for about a week, and I am still not feeling well.
Myalgias, headache, fatigue, loss of appetite, left shoulder pain, left arm pain.
1 day after the vaccine, I noticed itching around my wrists, under my breasts, back, back of my neck, in between my legs, and back of my legs.  It went away a night, but came back the next day.  The itching eventually turned to hives.  I've had hives before but not like this.  Also I noticed on Day 2 that my chest felt really heavy and felt like severe heartburn, I took Tums, and that went away, so unsure if that'st related.  The itching and hives went on until Day 4 after the vaccine, then I took an OTC Zyrtec Day 4, and Day 5 they went away completely.  Now I'm on Day 8 and I noticed itching on my hair/head, neck, and wrists.  I took another Zyrtec Day 8, today, and they haven't returned.
Blah feeling in am, took a 1 hr nap at 1pm, chills and then fever during the early evening, took 2 Tylenol, went to bed at 9 pm and slept until 6:30 am.  Woke up and continued on my day (Sunday)  Arm was sore for about 3 or 4 days after the shot and it itched.
Chicken pox; Got my shingles shot 2 years ago / very painful; This case was reported by a consumer via interactive digital media and described the occurrence of chickenpox in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced chickenpox and pain. On an unknown date, the outcome of the chickenpox and pain were unknown.   It was unknown if the reporter considered the chickenpox and pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received 1st dose of Shingles vaccine 2 years ago and experienced pain and chickenpox really bad as a child. The patient was glad that he/she had got it. The follow-up would not possible as no contact details were available.
pt recvd vax;exp local rxn consisting of entire arm redness & swelling, dec in range of motion w/ pain, fever, site hot to touch; tx w/ advil, ice & arm elevated;
This is a spontaneous report from a contactable consumer. This 28-year-old male consumer (patient) reported.  A 28-year-old male patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in right arm on 09Apr2021 12:30 PM (at the age of 28-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 18Apr2021 12:00 PM, after the vaccination, the patient experienced Shingles and skin tenderness began. On 22Apr2021 patient experienced Rash. Patient received Valacyclovir for shingles as treatment option. Patient took no other vaccines in four weeks and no other medications in two weeks. The patient was not diagnosed with covid prior vaccination and patient was tested covid post vaccination. No known allergies found. The outcome of the events was recovering at the time of this report.  No follow-up attempts possible. No further information expected.
ITCHY EYES; EYE SWELLING; This spontaneous report received from a health care professional concerned a 56 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: unknown) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-APR-2021, the subject experienced eye swelling. On 29-APR-2021, the subject experienced itchy eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from eye swelling, and itchy eyes. This report was non-serious.
DIZZINESS; RINGING IN THE EARS; This spontaneous report received from a patient concerned a 63 year old female.  The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user (3-4 glasses of wine/ year), and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of any drug abuse or illicit drug usage. The patient had no illness or regular medication. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A12A expiry: UNKNOWN) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. Age at time of vaccination 63 years old. No concomitant medications were reported. On 10-AUG-2021, the patient experienced dizziness, and ringing in the ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 10-OCT-2021, and had not recovered from ringing in the ears. This report was non-serious. This case, from the same reporter is linked to 20220714877 and 20220715147.
BLOOD CLOTS; This spontaneous report received from a patient concerned a female of unspecified age. 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, Expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested. Concomitant medications included Rivaroxaban.  On an unspecified date, patient experienced blood clots and she reports, she isn't sure if that is the cause. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210757480-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood clots. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
felt extra sore after the second shot.; This is a spontaneous report from a contactable consumer (patient herself). A 51-year-old female patient and received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8729, Expiration Date- 31Jul2021) via an unspecified route of administration in left arm on 13Apr2021 11:15 (at the age of 51-year-old) as 2nd dose, single dose for COVID-19 immunization. Patient medical history included that she was over-weight. The concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EP7534, Expiration Date- 31Jul2021) via an unspecified route of administration in left arm on 23Mar2021 11:15 as 1st dose, single dose for COVID-19 immunization and experienced "She had a period 09Feb2021 and 06Mar2021 and she did not have period again until 29Apr2021", body aches (ended on 25Mar2021 or 26Mar2021), very tired (from 23mar2021 or 24Mar2021 End date: 25Mar2021 or 26Mar2021), joint aches (End date: 25Mar2021 or 26Mar2021), sore arm, hurting (End date: 25Mar2021 or 26Mar2021) and diarrhea. Vaccine was not administered atFacility. Patient did not receive any prior vaccinations within 4 weeks. The patient reported on an unknown date Apr2021 that felt extra sore after the second shot. The adverse event did not result in the emergency room visit of physician office visit. The outcome of the event was unknown.   No follow-up attempts possible. No further information expected.
I went into this facility for a standard checkup and to recieve a Flu Shot. The Medical Assisant administered the incorrect vaccine (by not reading the label). She administered the HPV vaccine to me. I am currently 16 weeks pregnant. At the time of the appointment, I was 15 weeks pregnant.   This incident has caused me unbelievable stress and anxiety. This vaccine should not be given to pregnant women, as there are not enough studies/evidence to show the effects on the unborn baby and mother.
By 1405 pt was c/o throat feeling tight, tongue feeling thick and fatigue.  The symptoms continued unchanged x 15 min and pt was given 0.3 mg EpiPen.  15 min later symptoms resolved.
Soreness at injection site, Fever at 99.8 degrees F. Body Aches, headache
Patient says he felt tingling in his left hand after receiving FLUBLOK. RPh had patient wait in the store longer than usual time. Patient then said according to google RPh may have hit a nerve. He could tell because he had surgery on that arm years ago. RPh checked on patient later that day, patient said he still had tingling in hand on and off. RPh checked on patient today, he said left side of back in flank hurt.
Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion.; Vaccine administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion.) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 11:48 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 11:48 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 19.96 for dose administered on 28-Apr-2021.  No concomitant medications were reported.  On 19-Apr-2021, The vial with batch number 007C21A was moved to fridge. On 28-Apr-2021, Product moved to clinic and temperature excursion reported with 33 degrees fahrenheit at 09:00 AM. Beyond use date for the vial was reported as 19-May-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
since receiving immunizations has been fussy, not himeself, not sleeping, not eating well.
Muscle aches, palm size red ring for 3 days, day 4 rash, Diarrhea, vomiting, arm sore 3 days.
Information has been received from a nurse concerning a 2 month old female who on an unspecified date was vaccinated with ROTATEQ (lot# 660599/0208X) and other unspecified routine 2 month vaccinations. The next evening the patient had a seizure. The patient's outcome was not reported. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Was not feeling good; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Was not feeling good) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Cholesterol.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Was not feeling good). At the time of the report, MALAISE (Was not feeling good) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications included, medications for asthma and cholesterol were reported.   Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-048019 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Follow-up information received on 24-MAY 2021 contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-048019:
Five minutes after receiving the first dose of the Moderna vaccine, reported an acute headache. had vital signs monitored and was watched for 30 minutes for any additional reactions, then released to return home. She stated that the headache lasted for two days.
Headache.  Laid down, took 3 hour nap.  Felt a little better after nap.  Headache continued next day.  Took tylenol.  By day 2, felt fine.
Episode suggestive of seizure +- 48 hrs p/DTP/OPV/HIB/Hep B vax- pallor, diaphoresis, several minutes followed by 15-20 minutes of sleep;
Received pneumonia vaccine 12-13-2010. Within 5-6 hours severe pain at site. Seen next day & could not move arm, entire arm tender to palpation. Pt required physical therapy to regain normal arm motion.
Patient experienced nausea, vomiting, and diarrhea. She states she was dehydrated and weak and had to miss 2 days of work due to symptoms. Vaccine was administered on 8/21/17 around 5:45 pm and symptoms began later that night and persisted into the next day. Patient had recovered as of 8/26/17.
Patient complained of something going on in her body which she could not explain.  PCP could not explain and sent her to doctor after doctor.  All of who found nothing. Became weaker and weaker until could not walk, could not sit up in bed, in last stages, could not talk. Lost weight rapidly because something prevented her from eating.
Vaccine was expired on 27 Mar 2022 and was administered on 07 Apr 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 27 Mar 2022 and was administered on 07 Apr 2022) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 27 Mar 2022 and was administered on 07 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 27 Mar 2022 and was administered on 07 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported patient received second booster dose. No treatment information was reported.
ONE OF OUR PLASMA DONORS DONATED PLASMA ON 04/15/2019 AND RECEIVED HER VACCINE AFTER DONATING. SHE WAITED FOR 15 MIN AFTER RECEIVING THE VACCINE AND STATED SHE FELT FINE. SHE NEVER RETURNED FOR HER 2ND AND 3RD VACCINE. SHE RETURNED ON 07/15/2019 AND STATED THAT ON THE NIGHT OF 04/15/2019 SHE WAS VOMITING REPEATEDLY AND WAS HAVING TROUBLE SLEEPING BECAUSE OF NAUSEA. SHE ALSO REPORTED SOME HEADACHES. DONOR DENIED EXPERIENCING ANY OTHER SYMPTOMS. SHE FELT BETTER THE NEXT MORNING.
Clinical varicella with 8-10 vesicles on pink base, present on whole body. None at injection site.
Patient reported to the pharmacy window and stated she thought she was having an allergic reaction to the pneumovax vaccine. Upon physical evaluation, patient's arm was swollen and red from armpit level down to just above the elbow. Patient stated it did not hurt, or itch. Patient also stated she was not having any problems breathing and did not report swelling anywhere else on her body. Patient stated she noticed her arm swollen and red mid-day on 9/20/16 but had not taken anything for it as of the time of consult. Patient was instructed to take benadryl and call her pcp. Patient agreed to do so and left the pharmacy.
patient is not experiencing any symptoms; A 5 week old patient was administered a dose of ROTATEQ earlier than 6 to 12 weeks of age as indicated; This spontaneous report was received from a clinic coordinator referring to a 5 week old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 03-JAN-2020, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (strength, dose number, route, frequency, lot number and expiration date were unknown) for prophylaxis (product administered to patient of inappropriate age).  The primary reporter stated that the patient was not experiencing any symptoms.
Lesion on hands, elbows, knees and feet. Pt states the area itches. Denies any discharge from the site.
p/vax pt devel an inj site rxn described as cellulitis affecting the entire arm;
Hives started on lower back and chest/neck, still persisting. It has been a month now. It has spread to lower stomach, thighs, eyes, full back, armpits and often flares-up in the evening. I used Benadryl one time, hives subdued but returned within 24 hours.
Per patient report - patient developed a red, raised welt approx. 3 in x 3.5 in on L) upper arm the evening after receiving immunizations. Also reported low back pain, achy, no appetite and headache. Symptoms reported from 10/19/20-10/20/20.
R shoulder erythema, redness, warm, swollen.  P/D cellulitis.
No adverse reaction, patient tolerated well. Dose given from vial that was in the fridge longer than 30 days.
Symptoms started on 4/19 which was burning pain in my right outer hip radiating down my leg and also into my groin.  Pain was significant and Advil didn't help.  Saw rash on my right buttock on morning of 4/22 and got diagnosed with Shingles at my doctor's office that same day.  Was prescribed Acyclovir antiviral and Gabapentin for pain.  Took the antiviral the prescribed 7 days.  Have been on Gabapentin since.  Amitriptyline was added recently because the pain continues to not be under control and sleeping is a challenge.  It has been 19 days approximately since symptoms began and 17 days since diagnosis.  I don't know the outcome yet since I still have somewhat of a rash left.  The rash was large and and extended from the top of my tailbone down and out toward my hip down into the top of my thigh.  The antiviral helped in that blisters never really formed, although I do have the burning pain and itching on the rash and also in the nerve following all through the route down into my foot and groin.
Left  thigh has slight edema and erythema, left knee slight edema. Keflex. Benadryl as needed.
Right side of his face felt like it was drooping/paralyzed; hard to blink/close his eyes and really bad headaches behind the right ear.  11/30/09 Medical records and discharge summary received for DOS 10/26.  Final DX: Bell's Palsy C/O R side  facial and tongue numbness x3days.Facial droop. Eye won't close. Ptosis. Began 1 day s/p vaccine. Tachycardic, hypertensive. D/C to home stable.
I received 2nd shot on 2-23-2021. Went to bed but was woken up by severe migraine. Migraine went on for 4 days with my trying to combat it with the Tizanidine. Nothing stopped the pain. I have had severe and medium pa8n in my head, in my back right side 0f my head and right neck muscle since then. Nothing is stopping the pain and Ive been home bound in bed since then.  I have Cervical Dystonia which causes severe migraines and I take the Tizanidine for that. It has handled my condition fine till 2-24-2021 at 2am. I finally got into the dr last week and she has ordered Diazapam to help sleep but it has no effect. Im now scheduled for 2 MRI's June 3rd 2021. Its also possible I should be Botox shots to my muscle to stop it from spasming and causing the migraines. Whatever was in the 2nd Moderna shot, has caused my neck muscle to spasm non stop and is effected my whole right side of my head, the top and front area.