chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm sore). At the time of the report, VACCINATION SITE PAIN (Arm sore) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication history not provided. Treatment information was unknown. Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Outcome of the event changed unknown to recovered/ resolved
patient stated she got infection at injection site.  she went to urgent clinic and received antibiotic and pain med.  is OK now
The rash began as a faint red macular rash below the knee on the left leg before progressively spreading and involving the contralateral leg, lower abdomen, and bilateral upper extremities.  The rash was mildly painful but not pruritic.  She was otherwise asymptomatic.      On examination, the patient was afebrile and well appearing.  There was erythematous to violaceous palpable purpura scattered on the lower abdomen, lower legs extending to the feet, and forearms extending to the palmar hands.  The lower extremities had several dusky violaceous vesicles, some with superficial erosions.   Punch biopsy confirmed Leukocytoclastic vasculitis.  She was treated with topical corticosteroids and rash is still resolving.
About 12 hours later, I had a fever, chills, night sweats, body aches, and no energy.  Lifting injection arm was painful and also included redness and swelling underneath injection site.  As advised, it only lasted 24 hours. I did not take ibuprofen. I wish  that I had.  Maybe that should be suggested? I think that would be key. I will make sure to do that after second dose.
Two days post vax pt right arm was swollen, red, painful and warm at injection site. Pt treated with Benadryl and was seen in clinic, three days post vax. Swelling less than 10 cm at site and redness continues.
Extreme RAT and swelling with color purple and itching 5" long x 3" wide LD last about 3 days.
Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium
Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 07-JUL-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX, the patient suffered shingles rash around left eye, upper back, neck and chest areas. The patient was diagnosed with herpes zoster, dermal infection, and herpes zoster with keratitis in his left eye. The herpes zoster infection has resulted in continued care and treatment since the onset of his injuries till present day. As a direct and proximate result the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to the ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Herpes zoster, dermal infection  and herpes zoster with keratitis in his left eye were considered disabling. Upon internal review, herpes zoster with keratitis in his left eye was determined to be medically significant. Additional information has been requested.
Increased soreness in arm that extended up neck to head.  Had the vaccine 7 days ago now and is painful from area of shot thru neck and head.  Headaches which I rarely have. Stiffness in neck and arm.
Angioedema inside upper lip edema Narrative:  Upper lip edematous inside mouth
One week after the vaccine he started coughing up specks of blood.  He went to his PCP who wanted him to have a bronchoscope but it was a 2 month wait since everything is so backed up. Two weeks after the vaccine, numbness and tingling began in the hands and then began to travel to his legs and bilateral lower extremities. As the neuropathy got worse in his extremities, he began to feel like his legs were just giving out from under him and he began falling. States his calves lose the ability to support himself and he has caught himself from actually falling however there are 3 times he did not catch himself.
Pt recvd vax JUN92 & devel burning sensation upon injection as well as soreness & or an aching sensation in the arm; pt felt heaviness in the arm;
Heavy menstrual period; Injection site pain; This regulatory authority case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Heavy menstrual period) and INJECTION SITE PAIN (Injection site pain) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Overweight, Respiratory infection and Constipation. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and MAGNESIUM (MARINE MAGNESIUM) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy menstrual period). 04-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site pain). At the time of the report, HEAVY MENSTRUAL BLEEDING (Heavy menstrual period) and INJECTION SITE PAIN (Injection site pain) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were provided.    Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received included: details on additional event, concomitant medication and other concurrent conditions.
pt recv vax;mild redness around inject site x 2-3 days;27jul95 area began to get bigger & become warm to touch & hurt;3x2 1/2" cm brownish red discoloration of upper arm around inject site;afebrile; no adenopathy;
Patient has a seizure disorder.  the vaccine provoked ongoing fever spikes for 5 days.  these caused intermittent febrile seizures and clusters of seizures that were very different from her baseline seizures. some lasted a few minutes but others clustered for over an hour
8-18-09 Pt with severe left arm induration and erythema extending from elbow to left shoulder with painful ROM.  Tx'd with Medrol dose pack and Benadryl 25mg q 6hrs. 8-21-09 Pt in for f/u appt; Symptoms are resolving and discharged from care.
Pt recv vax on unknown dy; post vax pt exp shortness of breath & hives
approx 1/2 to 1 hrs p/vax exp h/a & itching all over;did not call to report this until 315PM;referred to ED
Pain in left arm lasted longer than 48 hours. Left breast was extremely swollen, heavy and tender by day 3 after my shot.  I had chills, low grade fever, and aches for two days. My left breast is still swollen, however not tender or pain.  I take Ibuprofen occasionally. No major issues /concerns from my previous vaccines.
Client stated he experienced blurred vision following vaccine administration. Fire Rescue evaluated patient.  Patient's symptoms subsided.  Per Fire Rescue, no further evaluation needed.  Client left at 1:22 pm.
Pt recv vax on 11/20/98; on 12/1/98 pt exp parotitis of LA &RA; tx=antibiotics
This spontaneous report was received from a licensed practical nurse refers to a 5 patients of unknown age and gender. On an unknown date in 2012 the patients were vaccinated with a dose of RECOMBIVAX HB (dose, route not reported) (lot # 671326/1522AA, exp date 21-APR-2014) which was stored in a refrigerator reading 36-46 F, but in a section of the refrigerator with intermittent excursion to 30 F since 11-JUN-2012. No adverse effect reported. Follow-up information has been received from the nurse reporting that patient #3 was a 2 month old female who on 10-JUL-2012 was vaccinated with the dose of RECOMBIVAX HB. The reporter also noted that the patient would be re-vaccinated at her next visit. This is one of several reported received from the same source. No further information is available.
102 fever all next day from 12 hours after the vaccination - recovered 100 fever 2nd day. - recovered nausea - mostly recovered, but haven't restored appetite pain, swelling in injected arm - 50% recovered. Arm started itching today - Tuesday itchy eyes, Have NOT recovered  headaches - 5 straight days now - Have NOT recovered Nagging dry cough - seems allergic, but I've never had allergies in 60 years.  Have NOT recovered
This spontaneous report was received from a licensed practical nurse and refers to a 8 week old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-OCT-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1608USA012794:
pt recvd vax & almost immed afterward devel 4 hives approx 5mm each in size, @ site of inject; administered DPH;
On January 30, 2021 I had temporary loss of vision in right eye lasting 4-5 minutes. This was 23 days after first Moderna dose.  Second Moderna dose was given on Feb. 4, 2021.  On  February 23, 2021 at 1 pm CST I had identical temporary loss of vision in right eye lasting 4-5 minutes. This was 19 days after second Moderna dose.
4/9/21 = 9pm EST, 102 fever, severe chills, back ache, pain at injection site, minor stomach pain 4/10/21 = 9am EST, headache 4/10/21 = 9pm EST, 101.5 fever, chills, back ache 4/11/21 = 9pm EST, 100 fever
Fever, sore musles, headache, dizzy and vomiting for 36 hours.
Got the first dose of the Moderna vaccine on 20Apr2021 on the left arm and has not gotten the second dose yet; Sick; Were so cold/could not get warm; They were shaking so hard/ shook for hours/hard shakes; Broke into a sweat; Shivering very hard; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), FEELING COLD (Were so cold/could not get warm), TREMOR (They were shaking so hard/ shook for hours/hard shakes), HYPERHIDROSIS (Broke into a sweat) and CHILLS (Shivering very hard) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder (thyroid condition), Migraine and Blood pressure high. Concomitant products included LOSARTAN for Blood pressure high, TOPIRAMATE for Migraine, LEVOTHYROXINE for Thyroid disorder.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced ILLNESS (Sick), FEELING COLD (Were so cold/could not get warm), TREMOR (They were shaking so hard/ shook for hours/hard shakes), HYPERHIDROSIS (Broke into a sweat) and CHILLS (Shivering very hard). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine on 20Apr2021 on the left arm and has not gotten the second dose yet). At the time of the report, ILLNESS (Sick), FEELING COLD (Were so cold/could not get warm), TREMOR (They were shaking so hard/ shook for hours/hard shakes), HYPERHIDROSIS (Broke into a sweat) and CHILLS (Shivering very hard) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine on 20Apr2021 on the left arm and has not gotten the second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Night around 3am started shivering Patient stated she didn't took her regular medicines on that day No treatment information was reported by reporter
Ever so slight tingle in tongue within 30 mins with difficulty moving legs.  Arrived home and slept 5 hours.  Spouse woke me up to eat.  I was polite and took a few bites.  Went to bed @ 10 pm.  The next morning I woke in the fetal position and COULD NOT MOVE!  Called husband for help.  He lifted me to the sit up position by my rib cage.  Very difficult to move for 4 days.  Had Gammagard treatment on March 16. 2021.  That was a mistake, I guess.  I could not even think clearly enough to try to fill out this form.
Patient is 22 2/7 inadvertently received 0.5ml of MMR, Varicella and HPV vaccines.
Later same day, couldn't move left arm well and bad headache.  Couldn't sleep that night.  This morning, 5/17 had fever of 100 and relentless headache, body aches and as of 5pm, fever now just under 101 with added sore throat.
Pt scheduled  for 2nd COVID vaccination (pfizer). While in observation after vaccine administration, pt reported not feeling well. Clinic caregivers monitored vitals and eventually moved patient from chair to bed located behind curtain in observation room. Pt started to become increasingly disoriented and experiencing shortness of breath. Pt condition rapidly concerning as was visibly and audibly struggling to inhale and exhale with significant facial redness. Epinephrine 0.3mg auto injection given once. Med team called after dose of epi. Rescue breathing using bag was applied as patient appeared apneic. Upon med team arrival RN administered another 0.3mg epi and brought pt to ED for further treatment and monitoring. Pt was discharged from ED in stable condition.
patient stayed sick for over a year with upper respiratory infection; sinus infections; bronchitis; other respiratory illnesses; Initial information received on 01-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (of unknown demography) who stayed sick for over a year with upper respiratory infection (upper respiratory tract infection), sinus infections (sinusitis), bronchitis and other respiratory illnesses (respiratory disorder), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication (s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient stayed sick for over a year with upper respiratory infection (upper respiratory tract infection), sinus infections (sinusitis), bronchitis and other respiratory illnesses (respiratory disorder) (non serious events, unknown latency) following the administration of INFLUENZA VACCINE.   No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reports, the outcome was not reported for the reported events.  There will be no information on the batch number for this case
itchy; Muscle ache; very tired the day after the shot; bones and muscles ached; very red area at shot site; swollen/also raised; raised round lump in the red area; Silver dollar sized lesion; This case was reported by a consumer and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (received Shingrix 8year ago and had  really light case of shingles.).   On 27th May 2020, the patient received Shingles vaccine. In May 2020, less than a day after receiving Shingles vaccine, the patient experienced injection site erythema, injection site swelling, injection site lump and skin lesion. On 28th May 2020, the patient experienced tiredness, musculoskeletal pain and muscle pain. On 29th May 2020, the patient experienced pruritus. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site lump, tiredness, musculoskeletal pain, pruritus, skin lesion and muscle pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site lump, tiredness, musculoskeletal pain, pruritus, skin lesion and muscle pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient received Shingrix at 3pnm and had tennis ball sized very red area at injection site also raised round lump in red area. The patient was very tired the day after the shot and all my bones and muscles ached and went to sleep. The patient still feels tired, red, swollen and itchy at the time of reporting. The reporter asked would it be ok to get the 2nd dose in several months. The patient only had one silver dollar sized lesion.
Narrative: Patient reported developing chills, anxiety, N/V, tingling/malaise and having a low grade fever of 99.4 after receiving second COVID vaccine
Took BP meds first thing this morning, normally have no issues, was fine.  Went to get 2nd dose and 2 hours after dose, felt very swimmy in my head, took BP and with meds it is 130/99. Not extremely high but I did take my meds at 8 am this morning.
Likely vaginal bleeding first noticed from stain on bed pad on 4/21/2021 and blood drops on toilet seat. Seen again a week later. Also apparent bruises to hand and wrist of unknown origin.
Started feeling a bit achy the evening of the shot.  (Note:  I had COVID-19 in late November and was warned that this could  be similar to the reaction to a second shot.)  The next day, I took Advil and went to work.  By noon, I was feeling worse - headache, aches.  I had a fever around 100 in the evening and started having chills.  That night, around midnight, I had a temperature around 102 and a bad case of the rigors.  I had a fever through the next couple of days.    The injection site is still sensitive to touch and itches as of 3/3/2021.
Swelling, mild itching, and pain at injection site starting about the size of a quarter and increasing about to the size of a 50 cent coin
Experienced coldness and tingling after receiving vaccine. Loss of strength in left hand. Tingle feeling began at elbow and continued for 30 min.
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: PATIENT WAS OK WHEN SHE LEFT
Office reports using a mixed schedule of vaxelis and Pentacel - vaxelis at 2 months, Pentacel at 4 months, vaxelis at 6 months, and Pentacel at 15 months with no reported adverse event; Initial information received on 27-Aug-2021 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown demographics patient who administered vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [VAXELIS] [Inappropriate schedule of product administration].  It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect VAXELIS not produced by Sanofi Pasteur (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  It is unknown if there were lab data/results available.  This was actual a medication error due to Inappropriate schedule of product administered (latency on same day).  It was reported "Office reports using a mixed schedule of vaxelis and Pentacel - vaxelis at 2 months, Pentacel at 4 months, vaxelis at 6 months, and Pentacel at 15 months."  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.