chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed vocational nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # L006386; expiration date 25-FEB-2017), dose and route of administration were not reported. Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Paleness, dizziness, weakness, fast heart beat, vomiting x1 approximately 5-10 minutes after vaccination. Laid down for 30 minutes then recovery.
Patient recieved Moderna booster dose of 0.25 mL less than 12 hours after expiration.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient recieved Moderna booster dose of 0.25 mL less than 12 hours after expiration.) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient recieved Moderna booster dose of 0.25 mL less than 12 hours after expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient recieved Moderna booster dose of 0.25 mL less than 12 hours after expiration.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Nausea for about 18 hours.  Also, congested, slight headache, achy, fatigue.
Left arm started itching and turning red with a raised welt, soreness and lump  below injection site
UPON INJECTION PATIENT FELT FAINT, HAD TO SIT WITH HEAD BETWEEN KNEES, COOL RAG ON BACK OF NECK.  BECAME ADAMANT ABOUT GETTING UP TO GO OUTSIDE DUE TO BEING HOT.  ASSISTED BY MYSELF AND RN TO WALK PATIENT OUTSIDE.  AT ENTRANCE DOOR PATIENT PASSED OUT, LOWERED TO THE GROUND BY RN.  HE DID HIS HIS HEAD ON THE FLOOR FROM APPROXIMATELY 2 INCHES FROM THE FLOOR.  HAD PATIENT AND MOM STAY AT OFFICE FOR 30 MINUTES PRIOR TO ALLOWING THEM T LEAVE.  PATIENT WAS GIVEN A DRINK OF SODA AND MOM WAS GOING TO LOCAL CONVENIENCE STORE TO GET HIM FOOD UPON LEAVING OFFICE.  MOM STATED HE HAD NOT EATEN LUNCH YET ON THIS DAY.  INSTRUCTED MOM ON SIGNS TO MONITOR FOR CONCUSSION, RECOMMENDED PATIENT TO BE EVALUATED AT PCP.  CALLED MOM THE NEXT DAY WHO REPORTED CHILD WAS DOING FINE WITH NO CONCERNS.
Back and leg pain; Back and leg pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 25-year-old non-pregnant female patient received second dose of BNT162B2 (lot no. and expiry date were not reported), via an unspecified route of administration on 11Jan2021 09:00 at single dose in left arm for Covid-19 immunization. Medical history included migraine, asthma, seborrheic dermatitis, and allergies to sweet potato, dust, dogs.  Concomitant medication included sumatriptan and acetaminophen. The patient took her first dose of BNT162B2 on 22Dec2020 at 09:00 in left arm at single dose for Covid-19 immunization. On 11Jan2021 at 14:00, the patient experienced back and leg pain. The patient had no covid prior vaccination nor tested for Covid post vaccination. There was no treatment received for the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Information has been received on 21-FEB-2017 from a registered pharmacist regarding a 39 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date the patient, who is 39 years old was vaccinated with either GARDASIL 9 (lot number, expiration, dose and route not reported) or GARDASIL 9 (lot number, expiration, dose and route not reported) for prophylaxis.  No adverse effects were reported. No further information was reported. Additional information has been requested.
Very sick; This spontaneous case was received on 24-Oct-2022 from other non-healthcare professional (consumer) via Agency (reference number: SEQW22-04974) with additional information received on the same day (being processed together) (reference number: SEQW22-04965), and concerned a female patient of an unreported age.   The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza virus vaccine, the patient got very sick.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  This case is linked with the case 202206182 (the same patient).  Company comment: Due to lack of information and unclear temporal relationship, causality for 'sickness' is assessed as unassessable.; Sender's Comments: Due to lack of information and unclear temporal relationship, causality for 'sickness' is assessed as unassessable.
This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, swelling arm, erythema of extremities, pain and tiredness. On an unknown date, the outcome of the influenza-like symptoms, swelling arm, erythema of extremities, pain and tiredness were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, swelling arm, erythema of extremities, pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had red swollen arm, was achy, tired and had flu like symptoms. All events lasted for 2 weeks. The reporter agreed to be followed up.
while injecting flu vaccine syringe or needle malfunctioned and only a partial dose was given - even after removing needle from patients arm the remaining vaccine could not be pressed out of the syringe - within 5 minutes patient began having arm pain at the injection site radiating up to the shoulder
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or concomitant therapies provided. At an unspecified date in the past patient has received PREVNAR 13. On 08-JUN-2017, the patient was vaccinated with PNEUMOVAX 23 lot # L029306, expiration date 26-MAR-2017, intramuscular (dose was not reported) for prophylaxis. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA007120: Original Case: 1706USA004082.
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant product reported by reporter.  Nurses had no standing order other than what they had for second booster, when first administering bivalent boosters. So they assumed the same dose as the second booster and administered 0.25 ml instead of 0.5 ml to uncompromised adults.  Patient received under dose of 0.25 ml of Moderna Bivalent Booster.  It was reported that CDC had recommended to re-vaccinate the patient with a full dose of 0.5mL.  No adverse events were reported.  No treatment medication reported by reporter.
developed chills, then slight fever, then nausea which progressed to vomiting, followed by fatigue and mild body aches. Side effects began approximately 6 hours post vaccination and resolved by approximately 32 hours post vaccination.
dose given after vials stored in dry ice box ran out of batteries. Temperature therefore unable to be monitored, thus deemed compromised by CDC
My son let me know that he tested positive, and we all live in the same house. After a couple days, I started running a fever and tested positive for COVID-19 on 9/13/22. By the next morning I had a sore throat, and body aches. I called my doctor, and he told me about PAXLOVID, and I turned it down that day. I called back the next day and had them call it in. I started feeling better a couple days after taking it.
Chills, weakness, lethargic, pain in arm that received injection, rash.
Patient complained of increasing pain after vaccine. Waited 2 days and pain continued to increase. By third day, she noticed swelling of right arm, tender to touch, erythema: area was hot/inflamed. Treatment: Rocephin 1 gram left buttock; Augmentin 875mg twice a day for 7 days
Swelling of limb and foot, rapid breathing, excessive sleep, food allergies, dermatitis, croup, improper immune response, vomiting, diarrhea, lost weight, poor growth 55th%, toes swelling and peeling, rashes, lethargy, pink stools, autism. Severe gastrointestinal difficulties.
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9, lot # N002720, expiration date 12-MAY-2019 (dose and route were not reported)  for prophylaxis. The vaccine was exposed from 32 Fahrenheit degrees (°F) to 35 Fahrenheit degrees (°F) for 1 hour. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
11/18/2022 My digestive system started acting up. Started with diarrhea, mild at first then got worse. Doctor thought my  liver was out of whack and not suspecting it might be the COVID shot. As it got worse, on Dec. 5, I was unable to keep any food inside of me. I was doing everything to stay hydrated. Finally got ammonia under control. Then it would go back and forth. Finally sent me to get an ultrasound on my liver and kidney. Showed a mass inside of kidney. Stopped drinking alcohol. Doctor finally came to a conclusion it had to be a side effect to COVID vaccine. Got everything back in balance.  Had adverse reaction for a month and a half. Latest blood work shows liver enzymes are getting back in balance. My liver is find, just needed to get back in balance. I don't believe the shot had anything to do with kidney mass, just would not have found it if I had not had issues with the vaccine.
On 9/15/00, developed fever of 101F-102F. On 9/16/00 PM, had rash on face in the AM that spread to back and chest. Still had rash on 9/20/00. Was also on medicine for ear infection. Saw MD (was with grandmother) and mom unsure of rash. MD said reaction to MMR.
nausea, dizziness, headache, body aches, fever(highest 102.3), chills, sweats.  have taken tylenol and dramamine
fever 102 mom states pt screamed x 14 hrs needed APAP w/Codeine to calm; emesis x 2; MD requested pt not to receive pertussis @ next immun;
Patient received Covid-19 primary series of Pfizer vaccine on 2/25/2021 Lot#EN6198 and 3/18/2021 Lot#ER2613.  Approximately 6 months after 2nd dose began to have weakness in her legs, arms and hands.  Eventually could not walk up stairs and was unable to hold things in her hands.  Seen by a neurologist in 2022 and diagnosed with chronic inflammatory demyelinating polyradiculoneuropathy and then began receiving immuglobulin infusions.
Right side of her upper lip swollen/ then the upper lip; Right cheek was swollen; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Right side of her upper lip swollen/ then the upper lip) and SWELLING FACE (Right cheek was swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), LISINOPRIL, ACETYLSALICYLIC ACID (BABY ASPIRIN), TIMOLOL, LATANOPROST, AMLODIPINE BESILATE (NORVASC) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced LIP SWELLING (Right side of her upper lip swollen/ then the upper lip) and SWELLING FACE (Right cheek was swollen). At the time of the report, LIP SWELLING (Right side of her upper lip swollen/ then the upper lip) and SWELLING FACE (Right cheek was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
loss of vision in eye transiently; diagnosed with giant cell arteritis; This spontaneous case was reported by a physician and describes the occurrence of BLINDNESS TRANSIENT (loss of vision in eye transiently) and GIANT CELL ARTERITIS (diagnosed with giant cell arteritis) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS TRANSIENT (loss of vision in eye transiently) (seriousness criterion medically significant) and GIANT CELL ARTERITIS (diagnosed with giant cell arteritis) (seriousness criterion medically significant). At the time of the report, BLINDNESS TRANSIENT (loss of vision in eye transiently) and GIANT CELL ARTERITIS (diagnosed with giant cell arteritis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Giant Cell Arteritis being treated by steroids.  Patient who received their Moderna booster dose in November of last year had experienced exacerbated symptoms which included : scalp burning, jaw pain, developed loss of vison in eye transiently and was then diagnosed with Giant Cell Arteritis being treated by steroids.  Company comment: This Spontaneous case concerns a 68-year-old, female patient with no medical history information reported, who experienced the unexpected serious (medically significant) events of Giant cell arteritis and transient vision loss. The events occurred on an unknown date after a dose of mRNA-1273. No information about dose number of vaccination schedule was provided. As reported, the patient experienced exacerbated symptoms which included scalp burning, jaw pain, loss of vison in eye transiently and was then diagnosed with Giant Cell Arteritis and was being treated by steroids. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This Spontaneous case concerns a 68-year-old, female patient with no medical history information reported, who experienced the unexpected serious (medically significant) events of Giant cell arteritis and transient vision loss. The events occurred on an unknown date after a dose of mRNA-1273. No information about dose number of vaccination schedule was provided. As reported, the patient experienced exacerbated symptoms which included scalp burning, jaw pain, loss of vison in eye transiently and was then diagnosed with Giant Cell Arteritis and was being treated by steroids. The benefit-risk relationship of mRNA-1273 is not affected by this report.
All over hive type body rash 5 days after vaccinations.  Benadryl OTC prn.
Two weeks after getting my second dose of the vaccine I noticed pain m in my left lower back. It persisted and on the third day I had some itching around my waist. That night I had a long red rash along my right side. I went to a doctor and I was diagnosed with Shingles. I was prescribed Valaciclovir. I had a mild case. There was some pain and itching. I had not had a Shingles vaccine. It has been five weeks and I still have the rash but it is not painful or itchy.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies or concomitant medication were not reported. In October 2016, the patient was vaccinated with PREVNAR (route, dose, lot # and expiration date were not reported). Then on 31-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 lot # M024673, expiration date: 17-NOV-2017 (route and dose were not reported) (inappropriate schedule of drug administration). No adverse event was reported. There was no product quality complaint (PQC) involved. Additional information have been requested.
pt recv vax; devel hives, started in thighs 2 hr p/ vax; worsened over next 5 days; now in 9th day, was told to take dph; some swelling,soreness & redness in upper arm,but gone now;hives still present;
Swelling and infection w/redness 4" total, at 2 inch wide infection within 4" redness. Given KEFLEX for the infection and had a severe reaction to the KEFLEX. I am still on meds for the reacton and seeing an allergist.
Patient admitted to the hospital with nonspecific paresthesia.  Patient immediately went to the ICU for observation due to questionable pulmonary status, but never required intubation; total ICU stay was 14 days.  Neurology was consulted and diagnosed the patient with Guillain-Barre syndrome.  He was treated with IVIG 36 gm daily for 5 days, with little improvement.  After completing the IVIG he received 5 days of plasmaphoresis.  Upon completion of the plasmaphoresis, he started to show improved strength and swallowing capabilities.  As patient improves it is anticipated that he will be transferred to a skilled nursing unit or inpatient rehab unit to complete his recovery.  11/19/2007 ER record received from 10/29/2007. Pt presented with abrupt onset of numbness of hands and feet, weakness, and feeling poorly. (+) walking difficulty.  PE (+) for ataxia, unsteady and broad-based gait. Loss of sense of touch both hands and leg.  Admitted  with assessment: Hypokalemia.  Weakness. Paresthesias. 11/26/2007 D/C summary recived for DOS 10/30-11/20/2007 with D/C DX:  Guillain-Barre syndrome.  Autonomic Instability.  Aspiration Pneumonia.  Dysphagia.  Peripheral Neuropathy.  Squamous cell carcinoma of the scalp. Neurology consult found no DTRs on PE.  Strength 3/5 and diminished sensation lower extremities.  Prelim DX was ascending sensory motor polyneuropathy, likely GBS.  Pt received IVIG and plasmapheresis with increase in strength noted.  Pt had an episode of aspiration which did not require intubation. Pt experienced orthostatic hypotension and worsening peripheral neuropathy (burning sensation in both legs) during hospital stay. D/C to SNF on 11/20/2007.   12/28/07 Additional records received. Pt re-admitted 11/20-29/2007 for Partial SBO and again 12/5-14/07 for inpatient rehab for mobility impairments.
Generalized rash to be treated with oral steroids and Claritin, outcome not yet known
Employee received Pfizer Covid19 vaccine on 09/15/2021 and 5 minutes after the vaccine was administered she began feeling pain at the injection site and upper and lower right arm and hand.  She also had swelling to the right  hand as well. She took 2 extra strength Tylenol at that time.  At about 6pm (9/15/2021) she had fever, headache, wheezing and tightness in her chest and she took 2 extra strength Tylenol. These symptoms lasted until 09/26/2021   Today 9/27/21 she only complain of mild pain at the injection site and upper and lower arm.
Continual left shoulder joint pain.... after shot  normal pain and swelling after shot but still get continual shoulder pain.
Abscess. Patient complained of tenderness and swelling at injection site 2 days after administration. Consistent with mild local reaction, progressed over next few days to draining, pain and swelling with sterile abscess.