chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever, pain in her throat, stomach pain. On 03/16/2017: pain in her legs, pan in her knees.
Patient noted diffuse macular rash to arms bilat.  Presented to this facility on 06/18/2013 c/o rash spreading and itching. Diffuse macular type rash to face, neck a&p, torso a&p, and limbs X 4 a&p. Rash consistent with that seen in early onset vaccinia. Patient sent to ER. Final disposition was to home with a anti itching medication.  No follow up or referrals given.
Information has been received from a health professional concerning an adult male patient who on 04/12/2004 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  In April,2004, soon after vaccination, the patient developed chikcenpox rash.  It was noted that the patient had recently moved to the United States.  The treatment was diphenhydramine hcl (Benadryl).  Unspecified medical attention was sought.  There was no product quality complaint.  The reporter also mentioned two other patients:  the patient's spouse who was vaccinated with varicella virus vaccine live (Oka/Merck) and developed a chickenpox rash, the patient's child who developed a rash through secondary transmission.  Follow up information indicated that the patient was a contractor and the reporter was unable to obtain information requested.  No further information is expected.
Developed red raised large hives over entire body the morning /p immun.  Some swelling of the face noted, itching present, no fever, hives present all day 8Dec90-started to subside 9Dec90, much better 10Dec90.
COVID-19.  Live-in Mother-in-Law, who also has (5) vaccines, came home Monday, 10/24, not feeling well.  Tested positive for Covid on Tuesday, 10/25/22.  Then my husband got it and tested positive on Friday, 10/28, even tho she had been isolating.  They did, however, share a bathroom.  Then I started not feeling well late Saturday afternoon, early evening, 10/29, and tested positive Sunday, 10/30/22.  Called my PCP was put on Paxlovid.  Symptoms in the beginning were feeling wiped out, like being hit by a freight train, extremely tired and sleepy, slept a lot, very low-grade fever once of 99 degrees (otherwise normal or low), bad sore throat, bad congestion, stuffy runny nose, and cough.  Around Day 5, on Thursday, I developed a terrible Mixed Tension Headache/Migraine, but could not take my usual medications due to contraindication with Paxlovid.  They are still occurring today, though less intense.  Also intensified my Myofascial Pain Syndrome, though this too has decreased in intensity.  Finally tested negative for the first time today, Tuesday, Nov 8th, after finishing the Paxlovid Saturday morning, November 5th.
soreness in upper arm, elbow, back, & shoulder on lt side;sudden short duration pain, p/sudden movement of arm;periodic sleep disturbance;use heating pad, Ibuprofen, APAP, Aleve, ben Gay, etc;
Administered vaccine after 12 hrs of 1st puncture of vial; Then it was put back to refrigerator and then next day on 16JUN2021 it was taken out of refrigerator; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) and PRODUCT STORAGE ERROR (Then it was put back to refrigerator and then next day on 16JUN2021 it was taken out of refrigerator) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) and PRODUCT STORAGE ERROR (Then it was put back to refrigerator and then next day on 16JUN2021 it was taken out of refrigerator). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) and PRODUCT STORAGE ERROR (Then it was put back to refrigerator and then next day on 16JUN2021 it was taken out of refrigerator) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to event was not applicable.  Concomitant product use was not provided by the reporter.   No treatment information was provided.
pt recv vax; swelling, redness, inc warmth & induration w/o abscess rt deltoid area;size of a small egg;
Patient was sitting in a chair outside the pharmacy for 15 minutes post vaccination. While sitting in the chair, patient fainted and fell onto floor resulting into scrapes on her face and swollen lip. Pharmacist asked patient if she had difficulty breathing, but patient did not have any issues with breathing. Provided patient with paper towel to wipe face, bottle of water, and ice pack to alleviate symptoms. Also checked blood pressure and had patient elevate feet until she was able to leave pharmacy. Patient did not need additional medical attention
Difficulty swallowing  Extreme throat pain and feeling of obstruction in throat Difficulty sleeping and staying asleep
On 1/9/21-Diaphoresis, O2 90%, respirations 22, increased weakness, wheezing bilaterally. Send to ER for evaluation and treatment. She was sent to ER, where she was admitted for 2 days, then expired there on 1/11/21
Patients arm swole up, bruised and as swelling went down, patient says she has itchiness down below (about 5-6 inches) injection site. Patient says she felt fine except for the swelling and bruising in her arem
t103 starting evening of shots 16JUN92; very irritable-screams when touched continues to eat; slept off & on last noc 16JUN92; no swelling or redness @ inject site; pt has rash;
Information has been received from a physician concerning a 72 year old male, who was also the patient, who on 21-JUN-2007 was vaccinated with a dose of ZOSTAVAX. There was no concomitant medication. On approximately 21-JUN-2007 the patient experienced pruritis at the injection site. On 21-JUN-2007 the patient experienced doctor received a dose of ZOSTAVAX and experienced the formation of a wheal, redness and pain at the injection. The physician was recovering from the AE's at the time of the report. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested.
Received ZOSTAVAX vaccine on October 20, 2015. Broke out in shingles rash on (L) side of back and spread to (L) abdomen. Rx with VALTREX and NEURONTIN.
Presented in office with rash. Rash characterized as red, blister like lesions on face, neck, chest, abd., (L) lower extremitiy.
Swelling, reddening of upper arm, intense pain and itchiness of skin w/burning sensation redness and swelling spread to elbow area.
The day following the immunization the right are became red with itching and a lump. States was the size of an egg. On the day of the visit the area was smaller and not raised. The redness extended approximately 10 cm.
Fever, rash, joint pains, dizziness, nausea, sore throat.
Chills, general malaise, nausea, sweats. 7 a.m. to 7 p.m.
Severe body ache, itching rash, armpit swelling, breast pain, muscle pain, fever, chills, bone and joint pain.
Flu-like Symptoms; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site discomfort (for tolerance of 1st, refer case US2019GSK079348).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporting physician was the concerned patient.  The age at vaccination was not reported. The patient experienced systemic flu-like symptoms. No additional details were provided.
Fever, headache,  sore feet, dizziness, swelling in left armpit,  coughing, wheezing
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 15-SEP-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026a21a and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-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 CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.            No concomitant and treatment medication reported.   This case was linked to MOD-2021-378416 (Patient Link).
Since the vaccine I have had irregular periods 45-60 days apart and they are very irregular.  I have bleeding in between for days  at a time and cramping. Before the vaccine I had a period 28-30 days apart that were regular and predictable. Before the vaccine I never had spotting or cramping between periods.
Cellulitis around vaccination site. Patient stated noticing increased redness, pain, and swelling on the night of Dec 4, 2013. Patient was prescribed Doxycycline 100mg tabs twice a day for 10 days.
Rash, started on my back. Went to the dermatologist in October and they thought it was hives, but won't clear up. We haven't changed anything in our environment. One month after it started, the rash continued. It has now spread to my arms, front torso, upper legs and buttocks. It's getting worse, also.
Racing heartbeat, Diarrhea, Chest pain, Hypnic jerks, Overall weakness and tingling throughout the body especially the legs
swelling tenderness, heat & erythema in 4x4 cm square lt lateral proximal shoulder of inject site;
The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the PRIVACY recommends being revaccinated at their earliest convenience.
itching all over, large local rxn, inc heart rate given medrol dose pack & told not to take flu vax again;
Patient received Tdap vaccine on 1/18/19 at about 2:20 pm. That same evening at 6:50 she was taking a shower and was feeling a bit lightheaded so I stayed in the room with her. She started crying b/c "everything went black" so I grabbed her and helped lower her to the floor. She was extremely dizzy for about 15 minutes but only temporarily was unable to see. There was no injury since I was with her in the room when this occurred.
pt recvd flu vax 22OCT93 & 29OCT93 noted onset of h/a which worsened; 30OCT93 to ER for eval; hospitalized 31OCT93-4NOV93; dx aseptic meningitis;
Case PHEH2016US023373 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to 45 year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscular into left arm on 06 Feb 2016. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error.
It was about, I think it was going on for a few days. I was having left chest and shoulder pain. I went to my cardiologist, she sent me to the hospital. I went to the hospital and they found out I had blockage and had a stint put in. I think that was June something.
3 cm area of erythema and induration with TTP at injection site.  Painful with any ROM of biceps or triceps. Given antihistamine and ibuprofen.
Spontaneous raised, red hives the come and go on abdomen, back, face, head, legs, arms, buttocks, etc. Hives have been ongoing since booster vaccine and have not resolved. Hives worsen when scratched and scratch marks become swollen and raised. Can happen once per day or multiple times. Usually resolves within a couple hours and then sometimes returns.
Described patient feeling fine the day after the vaccine (3/4/21), but by 3/5 she wasn't feeling well and was on the couch all day. By 3/8 she couldn't get out of bed, then was subsequently admitted to the hospital. Patient remained in hospital for ~2 weeks before passing away on 3/29/21.
14May86 had IBS & d that preceded 3-wk episode of migratory joint pain myalgia& T;similar episode last yr;8may87 had AM stiffness,myalgia& fatigue x 3 mo;dx:fibromyalgia;7may90 blurred vision & retrobulbar pain& paresthesia;dx:mononeuritis;
30-40min after 2nd Moderna Vaccination I became lightheaded, rapid HR, intense chest pain in center of chest, SOB, light headed, cotton mouth, and extreme fatigue.  Went to outpatient Surgery center next to where I got the vaccine.  Dr checked my O2 sats which were 85%, listened to lungs and heart and heard no problems, BP Normal, HR fast but regular.  I immediately could not stay awake due to extreme fatigue and slept for 2 hrs, then was better for 1 hr with minimal chest pain.  Then got muscle/body aches & fatigue continued & slept another 3 hrs.  Through night a lot of muscle/body aches,  & severe headache. Continued chest pain in middle of chest (2-3 hr duration relieved by Aleve & Hydrocodone), also SOB with minimal exertion & fatigue continued.
Information has been received from a nurse concerning a 65 year old female patient who on 13-OCT-2009 was vaccinated with a first dose of PNEUMOVAX 23, 0.5 mL, intramuscular (lot # 660717/0224X) that had expired on 11-SEP-2009. No adverse reactions reported. Follow up information has been received from the registered nurse concerning the 65 year old female patient without any illness at time of vaccination who on 13-OCT-2009 was vaccinated at private doctor's office/hospital with a first dose of PNEUMOVAX 23, 0.5 mL, intramuscular in the deltoid (lot # 660717/0224X) that had expired on 11-SEP-2009. The registered nurse reported that the patient experienced redness and soreness at injection site. No relevant diagnostic test and laboratory data were performed. The patient did not seek medical attention. At the time of the report the patient's outcome was unknown. No informed consent form signed. Additional information has been requested.
This spontaneous case reported by a consumer (subsequently medically confirmed), describes the occurrence of diarrhea in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 17, 2021, patient experienced diarrhea. At the time of the report, diarrhea outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant product use, treatment information and lab details not provided. Patient stated she went to her doctor and after a test, he determined the diarrhea was caused by antibiotics she had taken after oral surgery. Most recent follow-up information incorporated above includes: On May 11, 2021: Reporter comment added.
Patient's mother reported 2 seizures lasting 30 minutes, generalized. 12/22/05 Review of d/c summary. Diagnosis confirmed as seizure. Episodes of staring and perioral cyanosis were noted. No fever.
pt recv vax & approx 12 to 13 days post vax pt devel varicella-like w/over 15 lesions & a fever;
Pt received H1N1 vaccine 10/19 on Wed 10/21 pt experienced seizure activity of 10-15 total duration with 1 min seizure episodes and head shaking with eyes slightly opened with no associated full body mvmts with T. 103 deg rectally at ER admission. Admitted to hospital to rule out seizure etiology.  10/26/09 Hospital records DC summary received, service dates 10/21/09 to 10/23/09. Assessment: Flu A (+), otitis media, complex febrile seizure vs Flu A encephalopathy? Infant presented with febrile seizure episode lasting 15 minutes. URI symptoms including dry cough, nasal discharge, sneezing. Tympanic membrane erythematous, pharynx erythematous. Decreased alertness. Motor tone decreased. Fussy.
Fluttering sensation in right ear. There were many episodes of this multiple times a day for about a week.
Information has been received from a physician concerning a 6 year old white female with no known medical history or allergies who on 7/20/99 was vaccinated in the right arm with a dose of varicella virus vaccine live (lot # 630678/0427J). There was no illness at the time of vaccination. On 8/14/04, the patient developed a rash. The rash consisted of more than 50 lesions but less than 200 lesions. Unspecified medical attention was sought. The patient was given Acyclovir for the rash if needed and it was unknown if the patient did take the Acyclovir. Subsequently, the patient recovered. A product quality complaint was not involved. Follow up information from the physician indicated that there were no adverse events, but noted that the patient also had itching, slight cough and congestion. The patient was treated with diphenhydramine hydrochloride after the rash started. A visual exam was performed by the physician. It was reported that the recovery for the patient's itching, slight cough and congestion was ongoing. The patient had no adverse events following prior vaccination. No further information is expected.
Approximately 1 hour after injection, experienced strong facial numbness which lasted about an hour. Approximately 9 hours after injection, experienced very weak and shallow-breathing.
Pt reported localized swelling, itchiness, and headache following post vaccination. Physician recommended that the patient take OTC analgesics and cold packs.
nasal PCR positive; nasal PCR positive; This is a spontaneous report received from a contactable Nurse and a contactable physician. This is the 5th of the 11 reports.  A 28-year-old female patient received first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Dec2020 and 14Jan2021 separately, both at single dose for COVID-19 immunization. Medical history included ongoing seizures. Concomitant medication included ongoing lamotrigine (LAMICTAL) for seizure disorder. The patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient had nasal PCR positive on both 30Mar2021 and 02Apr2021. The patient did not have SARS-CoV2 antibodies at diagnosis. The outcome of the events was resolved in 2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test positive and vaccination failure due to temporal relationship.  Case will be re-assessed upon the additional information provided.,Linked Report(s) : US-PFIZER INC-2021389615 Same reporter/ drug/event, different patient
Morning of day after shot woke with fever of 100.5, which went up to 100.7 and didn't break until 12:20 a.m. of following day.  Some nausea late on second day.  Headache and dizziness started evening of the shot and resolved sometime second day after shot.
It is the Pfizer booster; red circular where the shot was; it is grown if you put three of your fingers together it is that wide and the length is that the length of your fingers; still pink, warm and it itches; Swollen a little bit and it had like a hard node begin with, now that hard node has spread out this is not as quite hard but it is still sick; red circular where the shot was; it is grown if you put three of your fingers together it is that wide and the length is that the length of your fingers; still pink, warm and it itches; red circular where the shot was; it is grown if you put three of your fingers together it is that wide and the length is that the length of your fingers; still pink, warm and it itches; Swollen a little bit and it had like a hard node begin with, now that hard node has spread out this is not as quite hard but it is still sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 30Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, I get both shot), for COVID-19 immunization; Bnt162b2 (Second Dose, I get both shot), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "It is the Pfizer booster"; PRURITUS (non-serious), ERYTHEMA (non-serious), FEELING HOT (non-serious) all with onset 30Nov2021, outcome "unknown" and all described as "red circular where the shot was; it is grown if you put three of your fingers together it is that wide and the length is that the length of your fingers; still pink, warm and it itches"; NODULE (non-serious), SWELLING (non-serious) all with onset 30Nov2021, outcome "unknown" and all described as "Swollen a little bit and it had like a hard node begin with, now that hard node has spread out this is not as quite hard but it is still sick". Therapeutic measures were taken as a result of pruritus, nodule, erythema, feeling hot, swelling. Additional information: Consumer stated, It was swollen a little bit and it had like a hard node begin with, now that hard node has spread out this was not as quite hard but it was still sick like that you can tell it was swollen and it itches and it was warm and it was pink so in another words, it was grown from the size of dime but now it was the size of three of your fingers. Consumer stated, "patient mean patient was just wondering what to do. Patient took some Benadryl (not a Pfizer product) thinking that would make it go away and it did not. Do you have a suggestion what to do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recv vax on 10/26/98; on same day pt exp lightheaded, dizzy, near syncope; pt to E.R.
PATIENT IS STATING HER ARM IS VERY SORE AND EXTREMELY PAINFUL THAT SHE IS IN TEARS, SHE FEELS THE INJECTION WAS GIVEN IN THE SHOULDER. SHE STATES HER MUSCLE ACHES, ENTIRE ARM HURTS AND CAN'T MOVE HER ARM
An expired vaccine was administered (12/31/21). The patient has not reported any adverse events.
Patient presented to emergency department on 10/4/2021 with nausea, vomiting, diarrhea, and abdominal pain. She tested positive for COVID-19 at a different facility on 10/2/2021 and received monoclonal antibodies. Patient was admitted for further management. Patient was discharged home with home health care on 10/8/2021.