chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 3:44pm, writer was paged to tend to patient who per monitor began having sudden hiccups. On writer's arrival to room, patient observed to have sudden onset abnormal breathing pattern and intermittent spasmodic hiccups. Writer called for additional assistance, oxygen and crash cart. Patient denied headache, dizziness, rash, throat discomfort, hoarseness, nausea, or chest pain. Patient was alert and verbal in between spasmodic hiccups with appropriate coloring; and she voiced that the active abnormal breathing happens when she gets an asthma attack. She simultaneously was reaching in her purse and worded "my pump".  Oxygen via NC at 2Lpm provided to patient. Patient self-administered 2 puffs of her Ventolin rescue inhaler, though observed patient's inability to hold breath adequately after each puff.  BP: 150/70 P: 98bpm RR: 22 Pulse oximetry 100% on 2LPM via NC. Dr. reached via telephone who ordered for patient to be sent out via 911 to hospital. Lungs and Heart auscultated by RN  no abnormal findings. At 3:55pm patient noted to have shallow rapid breathing, and voiced she felt lightheaded, weak and feeling a burning sensation in chest, and writer noted patient appeared to lose control over her head and neck. Patient repositioned to supine in recliner. Writer coached patient to control breathing with pursed-lip breathing technique and switched oxygen via NC to face mask, patient was able to follow commands well and remain alert.  Dr. ordered Diphenhydramine HCl 25mg IM STAT. RN administered Diphenhydramine HCl per order at 4:00pm to right deltoid without incident. EMS arrived and assumed care at 4:00pm. Patient transferred self from recliner to stretcher with EMS assist. Patient left facility via stretcher and 3 EMS attendants at approximately 4:15pm, verbally responsive and oriented x 4 without supplemental oxygen and in adequate control of her head and neck muscles. VS: 170/60 P: 88  O2 Sat: 100% on room air.
On Day 3 I started to develop severe coughing and sinuses problems, and a bad cold. The cough is so extreme that I keep vomiting and at times cannot breathe properly and have missed 4 days of work to date. A video appointment with my Dr suspected sinusitis and bronchitis and received antibiotics and cough syrup. As it didn't help and the cough became so severe, I sought urgent care on the evening of 01/04/22. An x-ray showed no abnormalities and the covid and flu tests were negative. I was given Prednisone and stronger cough suppressant medication.  I still suffer from severe cough and flu symptoms and I can only eat liquid food. I strongly suspect an allergic reaction to my 3rd dose, though I took the same (Moderna) as previously given. Hence, I'm reporting this as I'm very concerned for my well-being as well as for others.
Swollen and red at injection site, warm to the touch, treated for cellulitis with AUGMENTIN.
Patient started with a rash 3 days after injection started on (L) thigh, then spread all over torso and extremities. No other symptoms.
heartburn; lymph node swelling; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (heartburn) and LYMPHADENOPATHY (lymph node swelling) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPEPSIA (heartburn) and LYMPHADENOPATHY (lymph node swelling). At the time of the report, DYSPEPSIA (heartburn) and LYMPHADENOPATHY (lymph node swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-JAN-2016 at 09:27, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 8.6 (13 hours 13 minutes) and 7.9 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from medical assistant refers to a patient of unspecified demographics. The reporter stated that his office inadvertently stored single-dose vials of PNEUMOVAX 23 at 21 degrees C for 29 hours. On 21-APR-2014, the patient was vaccinated with improperly stored (inadvertently stored single-dose vials of PNEUMOVAX 23 at 21 degrees C for 29 hours) PNEUMOVAX 23 (dose, frequency, lot number and expiry dates were unspecified). Concomitant therapy was unspecified. No symptoms reported. No product quality complaint was involved. The outcome of patient received a dose of improperly stored PNEUMOVAX 23 was unknown. No other details provided. Additional information is not expected.
8 hours after getting the vaccine I started feeling very cold. It came on me all of a sudden.  Shaking, shivering, teeth chattering ensued along with generally feeling very unwell.  (Similar to how I felt years ago after having surgery)  This progressed during the night to fever, chills, extreme body aches, stabbing pains in the head, heart racing, dizziness and nausea.  After 12 hours I started to feeling improvement.  At the 16 hour mark I am really tired and nauseous but feel like I'm coming back.  Probably the worst I've ever felt.  We considered going to the ER in the night.
Patient reported that her arm was numb. No rash or swelling present. Patient denies pain. After talking to the EMTS, the patient reported that the numbness had subsided.
cryptogenic stroke; low blood pressure; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 16Mar2021 16:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation (age at vaccination was 56-year-old).  Medical history included hashimotos. Patient was non-smoker and daily exerciser. Patient received other medications in two weeks. Historical vaccine included 1st dose of BNT162B2 (Lot number: EN6203) on 23Feb2021 at 16:00 for Covid-19 immunisation (age at vaccination was 55-year-old). The patient experienced acryptogenic stroke 4 weeks following 2nd vaccination. No reason found. Normal BMI, no blockages, non-smoker, low blood pressure, daily exerciser. Onset date of acryptogenic stroke was 30Apr2021 at 18:30. Treatment for acryptogenic stroke was unknown. Patient was hospitalized for acryptogenic stroke for 3 days. Outcome of acryptogenic stroke was resolving. Outcome of low blood pressure was unknown. Patient had Nasal Swab Covid test date: 05Jul2021: Negative.  Follow-up attempts are completed. No further information is expected.
Patient said her arm has been sore off and on since vaccine with some weakness when the pain is happening.  Pain not bad eneough to seek medical attention
Information was received 30-MAY-2017 from a pharmacist via a telephone call. The pharmacist reported that on 21-APR-2017 a dose of VARIVAX was administered to a female patient via the muscular route rather than the subcutaneous route (lot # L049532, expiration date 08-DEC-2017).  (The patient's age, date of birth, concomitant medications, medical history and concurrent conditions were not reported.)  On an unknown date after receiving VARIVAX, the patient developed redness at the injection site, lasting for an unknown duration. No treatment for the redness had been received. The pharmacist reported that on an unknown date the redness had resolved completely. No additional information was provided. Additional information was requested.
muscle ache; muscle just jumps, like a twitch; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 72 year-old male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "muscle ache"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "muscle just jumps, like a twitch".  Additional information: It was reported that "the patient's 1st shot in Mar 2021. Months later, he notice that he get a slight muscle ache, it jumps, it was not that severe, but in the last 1 week or 2, he noticed that the muscle just jumps, like a twitch, but it does not hurt, he was not in pain. He had second dose in March. The person at the clinic told him that this may not be related to the vaccine, asking was that true.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
This spontaneous report as received from an other healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014, patients were vaccinated with LIQUID PEDVAXHIB (dose, route and lot number were not reported) that in January of 2014 were exposed to 69.5F for 72 hours. No adverse effects reported. This case is linked to cases 1403USA014177, 1403USA014486, 1403USA014488 and 1403USA014486 via same reporter link. Additional information has been requested.
PATIENT STATES SMALL, ITCHING FLUID FILLED 'BLISTERS' OR BUMPS FORMED NEAR INJECTION SITE AFTER ADMINISTRATION. AS OF 10/26/20, THOSE BUMPS WERE GONE AROUND INJECTION SITE BUT NOW PRESENTED ON LEG.  PATIENT STATES BUMPS ONLY ITCH, NO PAIN ASSOCIATED WITH BUMPS.
50 spots scattered on face, stomach, hands, legs, and diaper area started 10/4/03 and stopped erupting 10/15/03. C/o temp up to 101, cold sx, itching rash.
Metallic taste, rash and itching on forearms. Gave 25mg Benadryl. Observed for 30 minutes. Pt feeling better, returned to work.
2/19 woke up with pain in right arm, swelling at site, hot to touch, reddish discoloration, stinging, itchy, and noted right above the swollen are three red areas size of tip of my pinky. (these redish spots same on my first vaccination). A few hours after I took my temp and was 99.1.  I double checked and 99.1.  I took one Motrin for fever and couple hours no fever.  Today 2/24= Lump swelling decreased and warm to touch.  I have been applying Hydrocortisone Cream 1% for mild itching.
On 7/3/23, the patient was noted to have erythema and edema on her right upper extremity below the injection site (right deltoid).
Information has been received from a physician concerning a 15 year old female patient who on 14-NOV-2006, 16-JAN-2007 and on 12-JUN-2007 was vaccinated with the first, second and third doses of GARDASIL (Lot # not reported). It was reported that in "March 2009" the patient experienced weakness, pain in her legs and hips and the patient sought medical attention with the physician, then she was admitted to the hospital for three days on 07-APR-2009. It was reported that the patient was diagnosed with "acute demyelinating disease". The physician noted that the patient received gamma globulin for three days. It was reported that the patient was recovering but not fully recovered. The reporting physician considered "acute demyelinating disease" to be disabling. The Health Care Professional contacted during telephone follow up could not supply the following information: patient name and Lot numbers. Additional information has been requested. The patient was hospitalized.  8/14/2009  MR rec'd from PCP which includes Neuro consult in f/u to hospitalization with DX: CIDP/sub-acute polyradiculopathy. Pt developed fever, cough, cold sx, abdominal pain, H/A and stuffy ears 2/9/2009. Flu (+).  Dx: Viral Flu.  Returned 3/5/09 with c/o hip pain, numbness/weakness in both feet, muscle stiffness.  Had recent knee injury. Worsening by 4/2/09 and referred to neurologist. Admitted 4/23-29 with dx CIDP. Tx IVIG. Neuro f/u 5/22/09 with almost complete resolution of sx.  9/1/09 Hospital records received DOS 4/23/09 to 4/29/09 and 5/21/09 to 6/21/09.  Assessment: Chronic Inflammatory Demyelinating Polyneuropathy (possibly secondary to influenza illness)  Patient presents with bilateral upper and lower extremity weakness, influenza diagnosed 2/10/09. Fatigue, bilateral hip and calf pain. Range of motion decreased in lower extremiities. Reflexes absent. Wide-based stance. IVIG. Improved.
hives like on side of my neck and under my chin/ hives down my throat and left side of my face; I got blisters and burning sensation on my tongue; I got blisters and burning sensation on my tongue; redness; It's just little bumps; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0176) via an unspecified route of administration on 30Apr2021 at 23:30 (at the age of 56-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included thyroid condition. Concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 (lot number EW0151) on 08Apr2021. Seven hours after dose 2 of the vaccine (01May2021), the patient experienced hives like on side of her neck and under her chin. She put water on it and it went away. Around 12 midnight that night she started to get the hives down her throat and left side of her face. She got blisters and burning sensation on her tongue. She did not know what to do. The patient received treatment with diphenhydramine (BENADRYL). The hives went down and redness went away but she still had a little bit of hives. Her tongue still had bumps and like a burning sensation. The hives were still there but it was not red or itchy. It was just little bumps. Her tongue was still burning. It felt like when you drank something really hot and burned your tongue. She guessed she was allergic to it. The outcome of redness was recovered. The outcomes of hives and tongue still had bumps and burning sensation were not recovered. The outcome of blisters on tongue was unknown.  No follow-up attempts are needed. No further information is expected.
Migraine HA, (L) arm heaviness, numbness to (L) arm with tingling to (L) 5th finger, short of breath with (L) sided chest pain. Copy of urgent care record requested 10/12/11.
Client had one Varicella vaccine at age 1 yr and at age 12 dx'd with chickenpox
Low grade T (100) x 7d; (L) arm erythema day 6-8.
Diffuse skin redness on head, trunk and extremities, beginning 24 hours, post vax, and lasting 2-3 hours. Completely resolved without other symptoms.
SkinRash, UrticariaPruritus, Bilateral swollen ankles Narrative:
Pt contact our office today to report redness, swelling, pain, hot to touch left upper arm.  Pt seen at an Urgent Care, dx with Cellulitis and started on Keflex. Redness/swelling measurement 8.5 cm x 7.5 cm.
Severe diarrhea; Chills; Lethargy; This is a spontaneous report from a contactable consumer (patient) reporting for herself.  A 34-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: ER 8736), dose 2 via an unspecified route of administration, administered in Arm Left on 30Apr2021 at 08:30 (at the age of 34-years-old) as DOSE 2, SINGLE for covid-19 immunisation at Hospital. The patient medical history included, depression, anxiety, chronic insomnia and attention deficit hyperactivity disorder all from an unknown date and unknown if ongoing. Concomitant medications in two weeks included escitalopram oxalate (LEXAPRO), 20mg once a day and methylphenidate hydrochloride (CONCERTA) 36mg once a day both were taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EW 0158), dose 1 via an unspecified route of administration, administered in Arm Left 09Apr2021 at 08:00 AM as a DOSE 1, SINGLE for covid-19 immunisation at Hospital. Other vaccine received in four weeks was none. Patient did not have covid prior vaccination and was not tested for covid post vaccination. On 30Apr2021 at 11:00, the patient experienced severe diarrhea, chills, lethargy. Patient did not receive any treatment for the event. Outcome of all the events were recovering.  No follow-up attempts are possible. No further information is expected.
Extreme pain in upper arm, from neck down to wrist. Felt like aggravated nerve pain. Could not move arm for 3 days due to pain. Could not sleep or function. This is 4th day and I still do not have full use of my arm. Fatigue
Patient developed h/a 8/10right after injection he was observed and felt nauseous. ER MD came and saw patient   x2 patient allowed to go home. H/A better he stayed 1.5hours. he was transported by wheelchair to vehicle
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 at 07:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 37 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: ER8732), on 30Mar2021 as dose 2, single (Lot number: ER8732), on 30Sep2021 as dose 3 (booster), single (Lot number: FF8839) and on 22Apr2022 as dose 4 (booster), single (Lot number: FK9896) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "eczema" (unspecified if ongoing); "TMJ" (unspecified if ongoing); "urinary incontinence" (unspecified if ongoing); "OAB (overactive bladder)" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.
Very strong pain in the soles of the feet, especially the left foot. Pain is intermittent, it comes and goes.
This spontaneous report was received from a Licensed Practical Nurse, referring to a 17 months old male patient. The patient's pertinent medical history, drug reactions and allergies were unknown by the reporter. On 21-JUL-2106 the patient was vaccinated with PROQUAD (lot # M004895, expiry date 26-JUL-2017). The dose and frequency reported as once, subcutaneously. There was no concomitant medication reported. On an unspecified date in 2016 the patient's mother took him to the emergency room because the patient had a "diffuse rash". The reporter did not know if any treatment was given to the patient. At the time of reporting, the outcome of "diffuse rash" was unknown. Additional information has been requested.
Caller has bad knees and has not taken pain meds for 48 hours, and has been in agony; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Caller has bad knees and has not taken pain meds for 48 hours, and has been in agony) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced ARTHRALGIA (Caller has bad knees and has not taken pain meds for 48 hours, and has been in agony). At the time of the report, ARTHRALGIA (Caller has bad knees and has not taken pain meds for 48 hours, and has been in agony) had not resolved. Not Provided          No treatment Medication was available. No concomitant Medication was available. Action taken with mRNA-1273 in response to events were not applicable.
After the administration of SHINGRIX on 12/18/18 pt felt fatigued and wiped out but was aware this was a potential adverse event. On the morning of 12/25/18 pt awoke with soreness and swelling in lower back/upper legs at site of previous shingles outbreak. She came in concerned that the vaccine might be responsible since she had shingles in that site previously and had previously received ZOSTAVAX. I told her that the vaccine was new enough that I would file a report on her behalf. Patient also had surgery in this area in 2009 and 2013, but had not engaged in any strenuous activity that could otherwise have led to her reported symptoms.
Swelling and pain in the left arm and shoulder. Patient has been taking TYLENOL for the pain.
2 MINUTES AFTER RECEIVING HER VACCINE, SHE FELT LIKE HER THROAT WAS CLOSING. ON SITE EMS RESPONDED. SHE HAD NO PROBLEMS TALKING OR BREATHING.  AND NO COMPLAINTS WITH THE FIRST DOSE EITHER. VITALS ARE BELOW. 25MG DIPHENHYDRAMINE WAS GIVEN ORALLY.  SHE FELT BETTER AND WAS RELEASED HOME
spotting / menstrual cycle when it was not supposed to be; getting psycho; This is a spontaneous report from a Pfizer-sponsored program . A contactable 48 years old female consumer reported that she received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Feb2021, for COVID-19 immunization. Medical history and concomitant medications were not reported. Since 05Feb2021 the patient started having spotting after an hour (also reported as coup of hours) after receiving the vaccine and getting psycho. She had a menstrual cycle when it was not supposed to be. She had a regular menstrual cycle. She was on her full cycle as of 08Feb2021. The patient recovered on 07Feb2021.  Information on the lot/batch number has been requested.
Fever(101.1 degrees) even while on ALEVE, Pain in the left arm, Feels hard at the injection site started on 2nd day. Severe pain in the right arm, slightly swollen, feels hard at the site and unable to move the arm started on day-2. Lying down all day on day-5(5/11/18). Continuing to suffer from fever on Day-4.
cannot lift injection arm; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (cannot lift injection arm) and NAUSEA (nauseous) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (cannot lift injection arm) and NAUSEA (nauseous). At the time of the report, MUSCULOSKELETAL STIFFNESS (cannot lift injection arm) and NAUSEA (nauseous) outcome was unknown.            Concomitant medication information was not reported. Treatment information as not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.   Reporter did not allow further contact