chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, SARS-CoV-2 test: (Positive) Patient stated that after receiving her first dose, she was tested positive for COVID-19..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported. Patient stated that on 19-Mar-2021, she tested positive for COVID-19 though she did not show any symptoms and wanted to know whether she could receive the second dose.
Adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Adverse reaction). At the time of the report, ADVERSE REACTION (Adverse reaction) outcome was unknown.            Concomitant medications detail were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Non-Significant Follow up received on 08/Nov/2021-Document attached
No additional AE; HCP called to report inadvertent administration of a second dose of VAQTA to a patient earlier than recommended. The adult patient received a dose of VAQTA on 05/01/2023 and 09/30/2023. Limited patient demographics provided. No additional AE/PQC.; This spontaneous report was received from licensed practice nurse and refers to a 46-year-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-MAY-2023, the patient was vaccinated with first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 30-SEP-2023, the patient was vaccinated with inadvertent second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). The patient received a second dose elier than recomended (Inappropriate schedule of product administration). No additional adverse event was reported.
he administered PROQUAD IM into the deltoid instead of SC; No additional AE; This spontaneous report was received from a nurse and referred to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) subcutaneous injection, lot #W029553, expiration date: 14-MAR-2024, administered intramuscularly (IM) into the deltoid instead of subcutaneously (SC) for prophylaxis (strength, dose was not provided) (incorrect route of product administration); in combination with sterile diluent solution for injection/infusion, lot #U036871, expiration date: 11-MAY-2024, administered intramuscularly (strength, dose and indication were not provided). No additional adverse event was reported.
Pinprick red scar where the needle entered, Bruising around the shot area, Pain up to a level "8" on scale of "10".  Seen by 3 different doctors who diagnosed nerve damage and ordered Mobic for the Pain.  All these symptoms are still present as of 3/23/11.
There is a red lump with a "hole" in the center, the area is very itchy
Patient received pfizer vaccine on 12/2/21 and 1/6/22. Presented to ER on 6/22/22 and found to be COVID positive.  admitted on 06/22/2022 with COVID-19 pneumonia.  Patient was started on dexamethasone therapy since he was requiring supplemental oxygen at admission (baseline is ambient air but he required as high as 4 L/min; remdesivir presumably contraindicated because of renal impairment). There was a suspicion for PE but CT Angio was inconclusive; a V/Q scan was ordered but patient declined this testing. Acutely accelerated hypertension was also noted and appropriate antihypertensive medication optimization initiated with good results. The patient's respiratory status remained stable.  She was ultimately discharged back to his nursing home residence.  He will follow-up with his PCP within 1 week. Discharged on 6/24/22
Started with a runny nose next day, 3rd day had Severe migraine on the right side of the head with blurred vision and eye pain, light sensitivity and swelling of face, the base of the neck and at the site of injection and behind shoulderblade, Numbness of lips and burning mouth, Ongoing nausea, and upset gastrointestinal issues. Low-grade fever and chills, tremors in both arms and hands, upset stomach  Still have nausea and headache, body pains,, tremors, and strong fatigue. issues
legs began to get bigger at a greater rate and itch and hot to the touch; legs began to get bigger at a greater rate and itch and hot to the touch; legs began to get bigger at a greater rate and itch and hot to the touch; 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), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), PRURITUS (non-serious), FEELING HOT (non-serious), outcome "unknown" and all described as "legs began to get bigger at a greater rate and itch and hot to the touch".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
transient chest warmth and tingling in palate.  self resolved in 2 minutes. no medications given. monitored 30 minutes after symptoms resolved
watery blister on rib cage; burning sensations; This case was reported by a other health professional via call center representative and described the occurrence of blister in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced blister and burning sensation. On an unknown date, the outcome of the blister and burning sensation were unknown.   It was unknown if the reporter considered the blister and burning sensation to be related to Shingrix.  Additional details were reported as follows: No data available from Batch number or expiration date. All patient identifiers were provided. The patient received Shingrix and developed watery blisters on her rib cage and burning sensations after one week.  Reporter consented to follow up.
10/18/10: low back pain, feeling of malaise, decreased sensation in hands and feet, difficulty holding things and with ambulation. 5 days of immune globulin treatment, also pain control and physical therapy.
Vomiting started in the evening 10/16/13. No fever. Seen on 10/18/13 no wt loss, well appearing, but with intermittent vomiting.
Started with pain in lower left groin area with severe itching (no rash); then paralysis - unable to: raise my body up, roll to either side, move legs up. Excruciating pain in my left groin area with really bad pain in my buttocks, thighs, back.  Later pain in right groin area and same type itching on lower left leg ankle area with no rash.  When I could finally move, unable to lift up legs to climb stairs, extreme difficulty getting in and out of tub, showering and putting on clothes. Unable to lift arms up over head to comb hair or reach for objects.  Extreme pain in upper arm (left and right) with hard "knots" in deltoids both arms.  When able to move, had to use a cane to assist with mobility.
Mother stated her daughter's body became rigid, her eyes rolled back, and she briefly fainted.  Paramedics were called and she was taken to hospital.
REDNESS, SWELLING 3 X 3 INCHES TO INJECTION SITE.
Swelling, erythema and warmth at site and below on L arm.  Better today, but still red and hot to touch. Also, fecal incontinence.
Rash at injection site typical of varicella  3rd such reaction this mo. Must be related to properties of this lot of vaccine.
Fever- leading to febrile seizure. Fever began 24 hours after shots and lasted 3 days.
Information has been received from a newspaper article concerning a 24 year old female who in approximately July 2007, was vaccinated with a dose of Gardasil.  Less than a month after receiving Gardasil, the patient blacked out and had a seizure ("or what looked like one").  It was reported that her doctors could not figure out what's wrong.  At the time of reporting, the patient was still blacking out, dizzy all the time and having minor convulsions.  Upon internal review, the patient's seizure was considered an other important medical event.  Additional information is not expected.
"Patient" has asymmetry of skin of lower axillary area (fuller on right than left). Given extent of asymmetry an ultrasound of the area was oveder, which was normal.
Itching and redness to L deltoid. Itching/redness and swelling to R deltoid. 10/2/09 at 11:31-phone check to pt and she reports doing better and no more redness to sites.
rash, left arm small area; Fatigue; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash, left arm small area), INJECTION SITE PAIN (pain at injection site) and FATIGUE (Fatigue) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE PAIN (pain at injection site). On 03-Mar-2021, the patient experienced FATIGUE (Fatigue). On 04-Mar-2021, the patient experienced RASH (rash, left arm small area). On 04-Mar-2021, INJECTION SITE PAIN (pain at injection site) had resolved. On 06-Mar-2021, RASH (rash, left arm small area) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Father states child began c/o abd. pain, vomiting and diarrhea approx 4 hrs after vaccinations.  No other symptoms.  Seen at ER for symptoms on 9/16/09 and by PMD 9/18/09 for vomiting & diarrhea.  Pt. recovered by 9/21/09.
pt recv vax 24hr post vax & pt devel hives over entire body w/predominance on legs & abd;no other sx reported;no diff breathing;no SOB, no other swelling;tx w/DPH & did fine for itch & urticaria;
Pt said that 2 1/2 hrs after receiving Flu vaccine her throat tickled & she had cough. Then she started wheezing and couldn't sleep. Then she had fever and was shaking. Then her eyes became red and goopy. Then she had diarrhea & threw up. She had no fever. She did not go to hospital & she recovered next day.
Mother reports sudden onset of suicidal tendencies in child 4 weeks after having received HPV vaccine.  Per Mother, no signs of depression prior to receiving HPV vaccine.  Mother is requesting this be reported as an adverse reaction to vaccine.
MAJOR HAIR LOSS.  I have lost over 50% of my hair and now I have to see a Dermatologist to see what can be done to cease the contiuned hair loss.
Approx 45 min after receiving vaccines, mother reported rash on face, arms & chest without fever, SOB, or difficulty breathing. Called pediatrician. BENADRYL given. After 2 hour nap, symptoms subsided.
Just before lunch, he noticed that his skin was itchy, but he did not think much of it. He went to chow and did not eat he had a rash on his both arms, R>L, and both upper legs, inner aspect. Pain not associated with this complaint. Given Benadryl IM
Information has been received from a medica assistant concerning a patient who was vaccinated with a dose of PROQUAD.  On an unspecified date the patient developed a rash (site unspecified).  The patient sought unspecified medical attention.  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  Follow-up information was received on 20-Sep-2007 via a telephone call.  Medical assistant confirmed that an unknown patient developed a rash following vaccination.  This is one of several reports from the same source.  Additional information has been requested.
I started to heat up internally in the chest area approximately 1-2 mins after receiving the 1st dose of the vaccine. The burning sensation got hotter and hotter.  I asked the administer if I was supposed to feel anything. She asked what I was feeling.  When I told her, she gave me liquid Benadryl.   I started to feel better maybe 15-20 mins after that.  I stayed in observation at the pharmacy for about an hour before leaving.  I felt normal and thought it was over.  About 20 mins onto the interstate the burning sensation went over my whole body.  I also experienced a tingling in the back of my head.  I also got dizzy and felt very faint.  This episode lasted for about 20mins before calming.  I felt normal again for a 2-3 mins and it would happen again where I felt dizzy and faint.  This occurred multiple times in waves.  I called the paramedics and they recommended I take another dose of liquid Benadryl.  I went home and layed down and felt the burning in my stomach several more times throughout the evening and night..even the next day.  There was also extreme confusion all day the following day.  I was dizzy, confused, and spacey all of day 2.  The 3rd day felt a little strange as well.  I didn't feel like my self again until around day 4.
INJECTION SITE IS RAISED/SWOLLEN.  HOT TO TOUCH. LEFT ARM IS SORE AND THERE IS A BUISE AT INJECTION SITE.
Site: Itching at Injection Site-Mild, Systemic: anxiety/panic attack-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild
Fever, Rash, ErythemaMultiforn & NauseaVomiting Narrative: Fever, nausea, rash at injection site; took ibuprofen and benadryl. Recovering.
Swelling, redness and pain upper arm. Warmth to site. Redness is 13 x 15 cm.
Felt dizzy and lightheaded 8 minutes after vaccine. Felt like she was fainting. Monitored vitals .
fainting; Chest pain; shortness of breath; blurred vision; dizzy; Haven't been able to work with all this; left arm pain; weakness; hot/flush; muscle pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Nov2021 11:00 (Lot number: 32030bd) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid disease" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "covid " (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; LEVOTHYROXINE; OMEPRAZOLE; ASPIRIN [ACETYLSALICYLIC ACID] and anodizing. The following information was reported: SYNCOPE (medically significant) with onset 18Nov2021 17:30, outcome "not recovered", described as "fainting"; CHEST PAIN (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "Chest pain"; DYSPNOEA (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "shortness of breath"; PAIN IN EXTREMITY (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "left arm pain"; ASTHENIA (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "weakness"; HOT FLUSH (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "hot/flush"; DIZZINESS (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "dizzy"; VISION BLURRED (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "blurred vision"; MYALGIA (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "muscle pain"; IMPAIRED WORK ABILITY (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "Haven't been able to work with all this". The events "fainting", "chest pain", "shortness of breath", "left arm pain", "weakness", "hot/flush", "dizzy", "blurred vision", "muscle pain" and "haven't been able to work with all this" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were not taken as a result of syncope, chest pain, dyspnoea, pain in extremity, asthenia, hot flush, dizziness, vision blurred, myalgia, impaired work ability.
PATIENT HAD VACCINE ON 4/21/2009AM, CAME BACK ON 4/22/09PM AND WAS COMPLAINING OF PAIN AROUND THE INJECTION SITE, LEFT HAND TINGLING, LEFT SIDE OF FACE PAIN AND OVER LEFT SIDE OF NECK. DOCTOR ADVISE OVER THE COUNTER MOTRIN AND BENEDRYL EVERY EIGHT HOUR AND TO GO TO E.R IF NOT BETTER.PATIENT CAME BACK ON 4/25/09PM NOT FEELING ANY BETTER COMPLAINING OF LEFT ARM PAIN X 3DAYS, LEFT SIDE OF FACE NUMB, AND HEAD HURTS. DOCTOR SAID NOT INFECTION, REDNESS OR INDURATION. DR.  REFEERED FOR C-SPINE X-RAY AND NEUROLOGIST.
Severe aches,  teeth chattering, shakes, weakness, fatigue, unable to walk alone
This spontaneous report as received from a physician refers to himself who was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX on 24-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 26-AUG-2012 the patient experienced 4 to 5 vesicles on his left torso. The physician stated he had "pain in his back and itching and abdominal pain on his right side for the last several weeks." The physician went to his primary care doctor who have him a ZOSTAVAX vaccination 3 weeks ago. 2 days after the injection he got 4-5 vesicles on his left torso. He dismissed them as "bites". Then a day or two later, he started having knife like pain in his right back area about the thoracic area, itching around his right side and deeper pain in his right upper abdomen. His primary care doctor and he felt this maybe shingles and he was started on acyclovir for 7 days. The pain had persisted and no rash had ever come. He was having some back problems so he saw a doctor, and he suggested them did an ultrasound of his gall bladder and an MRI of his thoracic spine, to make sure this was not something else. Both were negative. Blood tests had been also been negative. From what he understood there had never been reported a case of shingles from the vaccination. Since he did not get a rash, he could not confirm this. The pain persists but was gradually getting better. It felt like a post neuralgia of some type. He wanted to talk with the doctor to see if he/she had any other ideas than letting it run its course. He was scheduled for surgery on his neck  next week and therefore he had been concerned about identifying what it was. He did not assume antibody tests would do any good, but it there were a way to see if this was varicella it might reassure him. Additional information has been requested.
pt recv vax 22JAN97 & 10 days later on the evening of 1FEB97 pt began to exp hiccups for 6-7hr, chills, fever & tingling & numbness in lt hand;the hiccups & tingling were ongoing @ the time of this report 10FEB97;pt consulted a MD;
Patient called and stated he felt heart fluttering that was diagnosed as a fib that progressed to acute congestive heart failure.
Got covid/covid rebound; Got covid/covid rebound; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP), Program ID: (Unknown).  A 45-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Latex" (unspecified if ongoing). Concomitant medication(s) included: VOLTAREN [DICLOFENAC]; TYLENOL; TRAMADOL; SULFASALAZINE; SERTRALINE; RESTASIS; OMEGA 3 FISH OIL [FISH OIL]; METOPROLOL; LEFLUNOMIDE; HYDROXYCHLOROQUINE; HYDROCORTISONE; GABAPENTIN; CLOBETASOL; CITRACAL [CALCIUM CITRATE]; BETAMETHASONE. Past drug history included: Allergies: amoxicillin, reaction(s): "Drug allergy"; Thiomersal for Drug allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "Got covid/covid rebound".  Clinical course: Patient "had to come off xeljanz xr for a booster, then got covid, then had covid rebound. been very sick. its been complicated lately" pt has been off xeljanz xr for about a month. (COVID)   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
AFTER ADMINISTERING BOTH SHOTS  PATIENT SAID TO HER MOTHER SHE WANTED TO GO EAT.. PATIENTS MOTHER WAS ASKING QUESTIONS TO PHARMACIST  EVERYONE WAS STANDING AND DURING THAT TIME PATIENT FAINTED.. SHE DID NOT LOSE COMPLETE CONSCIOUSNESS  HER EYES WERE OPEN . MOTHER AND RPH TOOK PATIENT TO BENCH WHERE SHE WAS GIVEN WATER AND CANDY BAR. SHE SEEMED TO BE BECOMING MORE ALERT. MOM DID STATE PATIENT HAS FAINTED WHEN NERVOUS ETC AND MAYBE DID NOT EAT THE WHOLE DAY. . PATIENT DID NOT WANT US TO CALL DR OR ANY MEDICAL ASSISTANCE. AND AFTER RESTING FOR 15 TO 20 MINS  SHE LEFT WITH MOM. DID CALL PATIENT 9/17/19 LEFT MESSAGE BUT NO REPLY BACK FORM PATIENT YET,
Patient identifiers obtained; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient identifiers obtained) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) 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) (unknown route) 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient identifiers obtained). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient identifiers obtained) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Description of Event or Problem: New crosslinked cases: MOD21-109324, MOD21-109532, MOD21-109542, MOD21-109544,MOD21-109546, MOD21-109548, MOD21-109552, MOD21-109553, MOD21-109567
HEAD TO TOES HIVES,  PAINFUL SKIN BURNING AND HORRIBLE ITCHING - FEELS LIKE NEEDLES STICKING HER,  SWOLLEN LIPS