chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received her first dose on January 4, 2022, second dose on March 25, 2022; No other Adverse Reactions reported; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her first dose on January 4, 2022, second dose on March 25, 2022) and NO ADVERSE EVENT (No other Adverse Reactions reported) in a 22-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 067F21A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: MODERNA COVID-19 VACCINE (Dose no. 1, Batch no. 012F21A and Right arm of administration) on 04-Jan-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE.    On 25-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her first dose on January 4, 2022, second dose on March 25, 2022) and NO ADVERSE EVENT (No other Adverse Reactions reported). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her first dose on January 4, 2022, second dose on March 25, 2022) and NO ADVERSE EVENT (No other Adverse Reactions reported) had resolved.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No other Adverse Reactions reported) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her first dose on January 4, 2022, second dose on March 25, 2022).    No other adverse reactions were reported after both the doses.  No concomitant medication reported. No treatment medication reported.
Case number PHEH2015US000673, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 54-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 11 Oct 2014. The pharmacist reported that FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours. The pharmacist does not believe that the vaccine was frozen instead thinks it was thermometer malfunction. No adverse event was reported following the maladministration (incorrect storage of drug). No further information was provided.
Pain, swelling and redness with urticaria by her description of the entire injected arm (above elbow).  This resolved except for persistent soreness until 2/22/2021 at office visit. No visible abnormality at the visit. Seventeen days after the vaccination she developed 2 mm pink round papules on the lower extremities with improvement over the next 48 hours.
diffuse urticarial rash involving posterior neck, back, chest, abdomen, upper extremities, and thighs. started on day #8. also with separate patch of petechiae on right lower leg that started on day #10.
pain and swelling at the injection site Narrative: pain and swelling of the injection site resolved within 48 hours
Information has been received from a certified medical assistant concerning a 23 year old white female with a penicillin allergy who on 28-NOV-2007 at 4:00 pm, was vaccinated IM into the left deltoid with a second dose of Gardasil (Lot# 659135/1265U).  On 29-NOV-2007, the patient experienced fever of 102 and rash on abdomen and leg.  On 30-NOV-2007, the patient went to the emergency room for left sided numbness and weakness of upper and lower extremities.  It was reported that the patient was discharged from the ER that same day after her symptoms improved spontaneously and her initial workup was unremarkable.  On 30-NOV-2007, laboratory diagnostic studies performed included a CT (non-contrast) of the brain that was reported to be within normal limits, a complete blood count and basic metabolic panel that was within normal limits, a chest X-ray PAL and an EKG that were within normal limits.  On 04-DEC-2007, the patient was seen by the physician.  It was reported that her symptoms had improved but they were still ongoing.  Additional information is not expected.
This case was reported by a other health professional via sales rep and described the occurrence of hives in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 6th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a day after receiving SHINGRIX, the patient experienced hives. The patient was treated with steroids nos. On an unknown date, the outcome of the hives was recovered/resolved. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: This case was reported by certified medical assistant (CMA). The age at the vaccination was not reported. The patient experienced hive like symptoms within the first 12 hours and worsened within the next 24 hours. The patient followed up the clinic on 9th August 2018, and that is when he received oral and intramuscular steroids. The reporter agreed to follow up.
71yo M received first Moderna COVID vaccine 5d ago. 24hrs following pt started having fatigue, vertigo, body and joint aches, intermittent runny nose, PND, throat irritation and gravely voice, decreased smell, loss of taste, chills, and fever to 104.2. Chronic dry cough which pt is unsure if has recently been worse. No ear or sinus pressure/pain. no respiratory concerns at present. +nausea, no vomiting, no diarrhea/loose stools, + decrease in activity, +decrease in appetite. Also yellow/rust colored urine x4d getting darker esp today w/ decreased urinary frequency. No burning or urgency. No urine blood clots. No BM for 4d w/ decreased appetite but did have BM today which was normal w/o blood, black, or tarry stool. Pt had heart stent placed 1mth ago and started on plavix along w/ his daily ASA and atorvastatin increased from 10 to 40mg. No CP or SOB.    Pt found to have elevated LFTs, alk phos, and bili  w/ hepatitis reaction.
Initially, just slight fever and pain at site. But, began with an intense and itchy rash a few days later that have persisted for the past five months. I've seen my GP and two dermatologists, an urgent care PA. Treated for scabies which it was tested for later and found not to be. I CANNOT PROVE THAT THE SHINGRIX VACCINE CAUSED ALL THESE SYMPTOMS BUT I AM SUSPICIOUS SINCE THEY OCCURRED AND PERSIST WITHIN DAYS OF RECEIVING SECOND SHINGRIX VACCINE.
General feeling of being tired and unwell immediately. Tiredness continued for about a month. I'd need to lay down a lot and rest. Still occurs just less frequently. Feelings of anxiety and fear and fatigue set in right away and lasted about 3 months. Heart palpitations started in the first few weeks. Now it's more fatigue and new neurological issues like internal tremors and brain wiggle.
Fever/chills, muscle pain, headache, tiredness. 2 days until nearly normal.
shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a 90-year-old female patient 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 HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) had resolved.            No concomitant medications were provided.  Treatment medications include antivirals for adverse event.
Please note that my symptoms were similar, but somewhat worse, than my first round of SHINGRIX vaccination (this was related to round two as I did not report round one).
M-M-R II was administered to 3 patients on 10/26/2020 after a temperature excursion and prior to having vaccines evaluated; This spontaneous report as received from other health professional refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 26-OCT-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection (lot number: S031482, expiration date: 07-OCT-2021, dose and route of administration were not provided) after a temperature excursion and prior to having the vaccine evaluated (improper storage of product in use). The vaccine was stored in temperature below 36 degrees Fahrenheit (2 degrees Celsius) (0.9 to 1.9 degrees Celsius) for 10 hours and above 47 degrees Fahrenheit (9 degrees Celsius) (9.1 degrees Celsius) for 30 minutes. There was no previous temperature excursion. Digital data lodger was not involved.  This is one of the three reports from the same reporter.; Sender's Comments:  US-009507513-2010USA010872: US-009507513-2010USA010939:
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 27-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. .; Sender's Comments:  US-009507513-2009USA006106:
Fever 102.  Redness, pain, and swelling left upper arm below injection site. Redness 14 x 9 mm band.  Soft.  Tender.  Warm.  No induration.
Tdap Vaccine was administered at the center (not at out clinic) - pt began to develop neurological sxs 3 days later and was seen at our clinic - was thought to have LBP and sent home to monitor. Sxs worsened to the point of inability to breath or swallow and was admitted to the ER where she was diagnosed with guillain barre syndrome.
I woke up at around 1:00 AM and had difficulty breathing. I also experienced some mental distress that abated after several hours. In the morning I felt better but evacuated (fecal) painfully and felt really hungry afterwards. I had been urinating periodically all night. I'm happy to report that after a substantial breakfast that I am feeling much better than last night. I decided to report the incident because I'm fit and slim, though old, and have concerns for people who aren't as strong physically and/or mentally (and spiritually) and suffer similar discomfort with more severe results.
red swollen to size of 1/2 baseball;whole shoulder aches, fingers feel numb;sl nausea, lightheaded, hot flashes, rash around neck;
This spontaneous report as received from a registered nurse refers to a 4 year old patient gender not reported. On 27-JUL-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # reported as L010145 exp date 24-MAR-017) (dose and route not reported) that was exposed to a temperature outside the recommended range. The patient had not reported an adverse experience. This is one of several reports received from the same source. Additional information has been requested.
mild SOB, lightheaded Narrative: 03/12/2021: 40 year old female received in left arm lot#044A21A exp 08/31/2021 Moderna.approximately 10 minutes after 1st dose. vet stated she felt nauseated, and mildly short of breath. she was observed for extra minutes and  she said she felt better.she attempted to walk from clinic and became lightheaded and was hyperventilating. "I feel tingling in my fingers and legs"vs's. sat 100% resp 24, pulse 100, bp 134/88. Hx of asthma and GERD. w/PMH s/f anaphylaxis to allergy shots (ER visit with Epi x2 the first time and epi x5 plus admission the second time) asthma, grass allergy, and eczema who presents to the ED With  nausea and pain in the back of the head and shoulders, throat irritation, facial redness with small hives, SOB, occasional cough, and fatigue 30 min after Covid vaccine #1 followed by anxiety, hyperventilation and chest tightness alleviated by albuterol. Sx similar to the onset of anaphylaxis after allergy shots. No wheezing, lightheadedness, tongue or lip swelling, or abd pain
began feeling bad about 24hr p/vax;Sunday AM felt very bad, aches-no appetite;Sunday noon-nauseated-vomiting lasting until Monday AM;Tuesday-feels ok-just weak;
3 days after receiving the vaccine I started to see an aura and then once the aura went away I had a severe ocular migraine. This is the first ocular migraine/aura that I've ever experienced in my life. I don't know if it was vaccine related, but I don't know of any other triggers. I was not under stress, my eating habits were typical, and I exercise every morning. I woke up the next day and still have the migraine. I've never had a migraine that lasted this long.
Feels like ants on my arm; arm is hot; skin of her injection site left arm is as hard as a knot; elbow to the injection site the area is painful; super bad body aches; area itches/itching is widespread/itching goes to shoulder blades/itching has become progressively worse since it first stared/itching is excruciating/My entire arm itches; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels like ants on my arm), VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE INDURATION (skin of her injection site left arm is as hard as a knot), VACCINATION SITE PAIN (elbow to the injection site the area is painful) and MYALGIA (super bad body aches) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Nov-2021, the patient experienced MYALGIA (super bad body aches), VACCINATION SITE PRURITUS (area itches/itching is widespread/itching goes to shoulder blades/itching has become progressively worse since it first stared/itching is excruciating/My entire arm itches) and PYREXIA (low grade fever). On an unknown date, the patient experienced FEELING ABNORMAL (Feels like ants on my arm), VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE INDURATION (skin of her injection site left arm is as hard as a knot) and VACCINATION SITE PAIN (elbow to the injection site the area is painful). On 14-Nov-2021, MYALGIA (super bad body aches) had resolved. On 15-Nov-2021, PYREXIA (low grade fever) had resolved. At the time of the report, FEELING ABNORMAL (Feels like ants on my arm), VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE INDURATION (skin of her injection site left arm is as hard as a knot), VACCINATION SITE PAIN (elbow to the injection site the area is painful) and VACCINATION SITE PRURITUS (area itches/itching is widespread/itching goes to shoulder blades/itching has become progressively worse since it first stared/itching is excruciating/My entire arm itches) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Menstrual cycle has been delayed after receiving first dose. It was on clock work before  that. Still monitoring.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unspecified age and gender. No medical history and concurrent conditions were reported. On an unspecified dates, the patients were vaccinated with unspecified number of improperly stored doses of RECOMBIVAX HB injection (lot # K0024552 and expiry date: 22-OCT-2016) (dose, route and site of administration was not reported). No concomitant medications were reported. No adverse effect were reported. The outcome of incorrect product storage was not reported. No product quality complaint (PQC) was filed. No additional information was provided. Additional information has been requested.
Itchiness; Nausea (all day); Headache; Sigificant arm pain; Redness; Swelling; Hard lump; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sigificant arm pain), ERYTHEMA (Redness), SWELLING (Swelling), INDURATION (Hard lump) and PRURITUS (Itchiness) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sigificant arm pain), ERYTHEMA (Redness), SWELLING (Swelling), INDURATION (Hard lump), NAUSEA (Nausea (all day)) and HEADACHE (Headache). On an unknown date, the patient experienced PRURITUS (Itchiness). On 09-Jan-2021, PAIN IN EXTREMITY (Sigificant arm pain), SWELLING (Swelling), INDURATION (Hard lump), NAUSEA (Nausea (all day)) and HEADACHE (Headache) had resolved. At the time of the report, ERYTHEMA (Redness) and PRURITUS (Itchiness) outcome was unknown.        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.
Facial swelling, left side, maxillary and mandibular areas. No pain, no redness, no increase in temperature. Mild pain on pressure on the area of swelling. No palpable lymph nodes
Patient admitted to the hospital for osteomyelitis of the right foot.  No fevers or upper respiratory symptoms on admission, but cough documented later in stay.
This case was reported by a consumer via call center representative and described the occurrence of shoulder blade pain in a 77-year-old female patient who received SHINGRIX for prophylaxis.  On 30th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 8th July 2018, 8 days after receiving SHINGRIX, the patient experienced shoulder blade pain. On 9th July 2018, the patient experienced pain in hip and neck pain. In July 2018, the patient experienced muscle soreness. On an unknown date, the outcome of the shoulder blade pain was recovered/resolved and the outcome of the muscle soreness was unchanged and the outcome of the pain in hip and neck pain were unknown. It was unknown if the reporter considered the shoulder blade pain, muscle soreness, pain in hip and neck pain to be related to SHINGRIX. Additional details were updated as follows: The patient received SHINGRIX on the left arm. On day 8, post vaccination, the patient's left shoulder blade was in pain and on day 9 the pain in shoulder blade was better. On day 9, the pain moved to both hips and the neck. Less than a month after vaccination her muscles were in pain and sore. The patient had denied permission to contact their physician. No further details were provided by the patient. All questions were asked.
Swelling at injections site, the size of an orange (per patient).  Tenderness and hot to the touch.  Went to ER late evening to make sure okay.
Pt developed varicella like lesions after having received vaccine 5 years before. She had temp of 103 at time. There was itching but no crusts.
We (and the doctors/nurse where administered) believe it was a Reaction to the MMR. She screamed for hours immediately after and thru the night. Had a fever off and on for over a week. Developed a rash about a week later that lasted for almost 7 weeks suffering in severity. Had diarrhea, horrific diaper rash, swollen feet and ankles. Appeared to be uncomfortable and in pain off and on, not herself for almost 2 months. Spoke to Drs on 7/19/17, 8/12/17, 8/17/17 and multiple other times as well as contacted nurses line. Overall she.
Felt jumpy on the injection site/right arm started jumping/"been jumping, jumpin jumpin jumpin", a muscle twitch; Felt jumpy on the injection site/right arm started jumping/"been jumping, jumpin jumpin jumpin", a muscle twitch; Arm is sore; Heart is pounding; I'm a little jittery. I am very nervous; I'm a little jittery. I am very nervous; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported), intramuscularly on the right arm on 27Jan2021 (10:00) at a single dose for COVID-19 immunization at the school/student health clinic. Medical history included diabetes diagnosed about 12 years ago; high blood pressure diagnosed about 30 or 40 years ago; and weight loss. Concomitant medication included insulin (INSULIN) for diabetes. The patient previously took influenza vaccine, sitagliptin phosphate (JANUVIA) and tramadol (ZALDIAR); and had rash on both medications. The patient had previously received a flu shot around the 6th or 7th of Dec2020. On 27Jan2021, at "about 4PM", the patient had felt jumpy on the injection site/right arm started jumping; it had "been jumping, jumpin jumpin jumpin, a muscle twitch". Also on 27Jan2021, at "about 4PM", the patient's arm was sore; heart was pounding; was a little jittery; and was very nervous. The outcome of the events, 'felt jumpy on the injection site/right arm started jumping', 'had "been jumping, jumpin jumpin jumpin, a muscle twitch"', 'arm was sore', 'heart was pounding', 'little jittery' and 'very nervous', was unknown.
Patient reported receiving covid vaccine through Agency, not through Agency  I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 2/24/2022 I82.409 ACUTE DVT, UNSPECIFIED VEIN 3/8/2022 J96.10 CHRONIC RESPIRATORY FAILURE 4/20/2022 J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 3/8/2022 J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/19/2022 I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 2/24/2022 I82.409 ACUTE DVT, UNSPECIFIED VEIN 3/8/2022 J96.10 CHRONIC RESPIRATORY FAILURE 4/20/2022 J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 3/8/2022 J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/19/2022
10/22 woke up with blood blisters in mouth, googled and did not seem serious, 10/23 still blood blisters plus bruising all over body and a headache. Went to ER, platelet count 3000....given platelets, IVIG and Dexamethazone, improved to 4000 that day. Hospitalized at Hospital given IVIG and Dexamethazone thru 10/25 and discharged from hospital, 10/26 last dose of dexamethasone. Follow up platelet count over 300,000.
10 minutes after vaccination patient complained of swelling in lymph node in right side of neck and swelling in right hand.  Swelling was visible in hand.  Patient given 25 mg of Benadryl.  15 minutes after Benadryl given, swelling in neck subsided but swelling in hand remained.  Patient did not want to go to hospital.  Patient instructed to call physician or go to ER if symptoms increase.