chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea, vomiting, lightheadedness, diaphoresis about 10 minutes after vaccination. Improved after about 5 minutes with sitting and water. No rash, cough, shortness or breath, palpitations.
Initial report was received from a health care professional on 15 September 2010. A four-year-old male patient with no reported past medical history, had received FLUZONE, lot number UT3567AA (route and site of administration not reported) on 13 September at 10:00, and an unspecified amount of time later, experienced a temperature of 103.1, itching all over, and coughing. He was noted to be pale, weak and had dark circles underneath his eyes. The patient was treated with CLARITIN, TYLENOL, and a "bath". His temperature responded to initial treatment but was reported to have increased to 104.3. The child was reported to be "feeling better" 24 hours later, however he was not reported to have recovered. No further information was available at the time of this report. Documents held by sender: none.
no additional AEs; CMA calling to report that PROQUAD was administered via IM route to 4 year old patient on 12/16/22. No further information provided, no additional AEs, no PQCs.; This spontaneous report has been received from a medical assistant referring to a 4-year-old male patient.   The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 16-DEC-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, 0.5 ml once (strength, dose, units, vaccination scheme, frequency, route of administration and anatomical site of injection were not provided), lot number W028564 has been verified to be a valid lot number with expiration date on 06-MAR-2024, administered as prophylaxis via Intramuscular instead of subcutaneous (subcutaneous injection formulation administered by other route). No additional adverse event was 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 15-DEC-2015 at 02:42, 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 7.9 and 4.6 (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.
Kidney issues; Lowplatelet count; Tired; This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (Kidney issues), PLATELET COUNT DECREASED (Lowplatelet count) and FATIGUE (Tired) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for an unknown indication.    No Medical History information was reported.   On 01-Sep-2019, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL DISORDER (Kidney issues), PLATELET COUNT DECREASED (Lowplatelet count) and FATIGUE (Tired). At the time of the report, RENAL DISORDER (Kidney issues) outcome was unknown and PLATELET COUNT DECREASED (Lowplatelet count) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: Low.         It was unknown if the patient was enrolled in COVID-19 vaccine trials.  No concomitant product reported by reporter. No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
1 dose of kinrix administered to a 8 years old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included pediarix (has all other Pediarix doses as needed) and infanrix (has all other Infanrix doses as needed).   On 23rd October 2020, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 23rd October 2020, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 1st dose of Kinrix was administered to the 8 years old patient, which led to inappropriate age at vaccine administration. The reporter stated that, the patient had all other pediarix and infanrix (dtap and IPV series) as needed (no details were provided) and was short of the Kinrix. The reporter consented to follow up.
Extreme fatigue, weakness, dizziness, muscle soreness, profuse sweating-no fever detected, heart seemed to race at times, headaches.  Started the morning after vaccine, and is still continuing today, 5th day, 5/18/2021.  I had to see my doctor today due to symptoms continuing and not improving. Doctor did a Covid test to make sure I didn't now have Covid. Was advised to rest and drink fluids.
Flu- like symptoms; Stinging; cold; Infection at the injection site; muscle pain/body hurt; chilis; Itching; hot flashes; Burning; injection site ( left arm) was sore; injection was hot feeling; Redness; injection site became more swollen, got as big as a size of a grapefruit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (injection was hot feeling), PRURITUS (Itching), ERYTHEMA (Redness), HOT FLUSH (hot flashes) and INFLUENZA LIKE ILLNESS (Flu- like symptoms) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injection was hot feeling), ERYTHEMA (Redness), VACCINATION SITE SWELLING (injection site became more swollen, got as big as a size of a grapefruit) and VACCINATION SITE PAIN (injection site ( left arm) was sore). On 19-Apr-2021, the patient experienced PRURITUS (Itching), HOT FLUSH (hot flashes) and VACCINATION SITE PAIN (Burning). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu- like symptoms), PAIN (Stinging), NASOPHARYNGITIS (cold), VACCINATION SITE REACTION (Infection at the injection site), MYALGIA (muscle pain/body hurt) and CHILLS (chilis). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache, at a dose of 300 milligram; IBUPROFEN, PARACETAMOL (ADVIL DUAL ACTION) at a dose of 1 dosage form and DOXYCYCLINE HYCLATE at a dose of 100 milligram twice a day. At the time of the report, VACCINATION SITE WARMTH (injection was hot feeling), PRURITUS (Itching), ERYTHEMA (Redness), HOT FLUSH (hot flashes), INFLUENZA LIKE ILLNESS (Flu- like symptoms), PAIN (Stinging), NASOPHARYNGITIS (cold), VACCINATION SITE REACTION (Infection at the injection site), MYALGIA (muscle pain/body hurt), CHILLS (chilis), VACCINATION SITE SWELLING (injection site became more swollen, got as big as a size of a grapefruit), VACCINATION SITE PAIN (Burning) and VACCINATION SITE PAIN (injection site ( left arm) was sore) outcome was unknown.            The concomitant medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-071541, US-MODERNATX, INC.-MOD-2021-085860 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071541:crosslinked US-MODERNATX, INC.-MOD-2021-085860:crosslinked
leg was hurting and had a hard time to get out of the chair; Tried to sit in the kitchen chair which is hard, and also had hard time walking; can hardly bend the leg and that didn't hurt when was laying in bed; goes from the groin area to the toes; A spontaneous report was received from a 83-years-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events leg was hurting and had a hard time to get out of the chair,  tried to sit in the kitchen chair which is hard, and also had hard time walking, swelling goes from the groin area to the toes and can hardly bend the leg and that didn't hurt when was lying in bed.  The consumer's medical history was not provided.   The consumer's current condition included congestive heart failure (CHF).  No relevant concomitant medications were reported.  On 23-FEB-2021, prior to the onset of the events the consumer received second of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20-JAN-2021, prior to the onset of the events the consumer received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 03-MAR-2021, after the second dose the consumer experienced events leg was hurting and had a hard time to get out of the chair,  tried to sit in the kitchen chair which is hard, and also had hard time walking, swelling goes from the groin area to the toes and can hardly bend the leg and that didn't hurt when was lying in bed.   No treatment information for the events was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome for the events was unknown.  The assessment was not provided for the events.; Reporter's Comments: This case concerns an 83-year-old female with PMH of CHF who had serious unexpected events of pain in extremity and gait disturbance along with nonserious unexpected limb discomfort and peripheral swelling.  Event onset occurred 9 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Could not control right leg and arm, could not walk w/out help, kaleidoscope vision bursts, fever, chills, extreme fatigue, lethargy, headache, diarrhea.
COLD SYMPTOMS: SORE THROAT, RUNNY NOES, CHEST CONGESTION.
swelling of the eyelids, sneezing, stuffy nose, itching of the eyes  & nose, tightness in the throat, swelling & redness of upper & lower eyelids;
10/12/05 pt received Hib vaccine that pm mild fever and fussy per mom. 10/13/05 when mom removed band aid notice red welt at injection site. Later that pm become very red and swollen. Pt very happy no signs of discomfort or pain even when pressed on site. Continued to be red and swollen around injection site for several days. 11/8/05 pt came in for flu vaccine small knot still noted at injection although no noted redness, swelling or tenderness.
This spontaneous report as received from a medical assistant refers to 10 patients of unknown demographics. On unknown dates patients were administered (Oka/Merck) VARIVAX (dose, lot., route of administration unknown). The medical assistant that these patients were administered (Oka/Merck) VARIVAX that was improperly stored. No adverse effects reported. Product quality complaint was not involved. Outcome of events was unknown. Additional information has been requested.
Case number PHEH2014US020815 is an initial spontaneous report received from a pharmacist on 16 Oct 2014. This report refers to a 13 year old female patient. The patient was very allergic to dogs and her concomitant medications were not reported. On 16 Oct 2014, she was vaccinated with FLUCELVAX (batch number: 161207) intramuscularly. On the same day, after the vaccination, she developed an anaphylactic reaction. The patient completely recovered from the event on the same day. The seriousness and causality of the event were not reported.
About 72 hours after DtaP vaccination patient was observed to have 3 seconds of staring and trembling of whole body including arms and head. Per mom resolved spontaneously.
Complaints of shortness of breath and intermittent "shooting" pain to anterior midsternal chest for approximately 10 minutes. Symptoms began approximately 30 minutes after receiving Hepatitis B vaccine.
This child had immunizations on 01/29/01, hives developed on 01/30/01.
no adverse effect; ursv; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.       On 05-NOV-2019, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # 1658256 has been verified to be a valid lot number, expiration date was reported as 18-NOV-2020) for prophylaxis. It was reported that the vaccine experienced a temperature excursion of above 9 degrees Celsius (9.4 C) for 20 minutes (product storage error). There was no previous temperature excursion. There were no adverse effects reported. There was no product quality complaint involved. It was reported that this call was reported due to a digital data logger.  This is one of the five cases received from the same reporter.; Sender's Comments:  US-009507513-1911USA002785: US-009507513-1911USA002735: US-009507513-1911USA003116: US-009507513-1911USA003130:
Symmetric bilateral thigh pain along the external edge of both legs, intermittent but always present, got worse with movements to the point that his gait was abnormal secondary to pain. No abnormalities in motor strength, noticed hyperalgesia bilaterally.  The pain would often be so severe it would wake him up from sleep.
onset of right calf muscle pain 3/29/21. Pain resolved after 3 days. On 4/5/21, had vever, SOB and back pain and headache.. COVID test 4/6/21 negative. Saw PCP 4/8/21 and 2nd COVID 19 test done and negative. CXR done and dx with pneumonia. Given Antibiotics and steroids. Sxs improved. All sxs returned 4/13/21 and different abx given with albuterol inhaler. Mild improvement but still with dyspnea then on 5/14/21, had back pain returned and went to PCP who sent her to ED and blood clots found. She was in Hospital and was told clots likely due to her estrogen-containing BCP and long drives.
liquid leaked out of the site of injection after vaccination/The patient is worried and scared, don't know if  received full dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (liquid leaked out of the site of injection after vaccination/The patient is worried and scared, don't know if  received full dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced ACCIDENTAL UNDERDOSE (liquid leaked out of the site of injection after vaccination/The patient is worried and scared, don't know if  received full dose).        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.
pt recvd vax & 1 day later devel redness, pain, swelling & warmth extending from shoulder to elbow; seen by MD who prescribed cold compresses & elevation; sx lasted 5 days
SEVERE shaking all over, difficulty breathing, racing heart, headache, dizziness, muscle pain, and muscle weakness. I just tried to wait it out. The shaking (extremely bad, could not control my own muscles at all and I had to lay on my arms so they wouldn't flail out) and racing heart lasted about five hours. The headache and all over muscle pain finally eased up last night. Breathing aches and I am still experiencing muscle weakness.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PYREXIA (fever). On 23-Feb-2021, PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 103 103.
right sided numbness involving whole body; .She also complains of 'poofiness' of right side of body without any swelling noticed; pain in whole right side of body that was more than generalized body aches.; This is a spontaneous report from a contactable physician. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E020176) via intramuscular route of administration in the right arm on 30Apr2021 at 15:00 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. Medical history included anxiety. Concomitant medications included etonogestrel (NEXPLANON) insert in left arm for unspecified indication from an unknown date. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) for unspecified indication on unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 00:00, the patient experienced right sided numbness involving whole body and also complained of  'poofiness' of right side of body (without any swelling noticed). The patient also felt pain in the whole right side of body that was more than the generalized body aches. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events right sided numbness involving whole body, 'poofiness' of right side of body without any swelling and pain in the whole right side of body that was more than the generalized body aches was recovered on unknown date of May2021.   No follow-up attempts are needed. No further information is expected.
Crying incontrollable, both legs turned purple, Hot to touch, feet turned red. Immediately after last shot given (PCV13), mild inspiration stridor, noted by Dr., which was ordered SOLUMEDROL 10 mg IM x 1 O2 100%, HR 137 via toe.
Patient stated 2 days after receiving vaccine he was having trouble breathing and was hospitalized and seen by pulmonologists there. Did not specify how long he was there. But since then he has had trouble breathing and was in a scooter with a oxygen mask on. Cannot move or walk without breathing issues.
shingles; Information has been received from a lawyer and a male patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a health care provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
I had three slanted lines across my left cheek.  It turned out to be Shingles on the right side of my face.  I had my Covid shot prior to the breakout on the right arm.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 70 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (ciprofloxacin allergy), and other pre-existing medical conditions included: Patient had no illness at time of vaccination, no past history of similar event, no adverse event after any previous vaccination(s). Patient had no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days, with cause. Patient had no family history of any disease (relevant to vaccination) or allergy. Patient was not pregnant  and was not breastfeeding at the time of vaccination. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: Unknown) dose was not reported, dose number in series 1, 01 in total, administered on 30-MAR-2021 in left arm for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, dose number in series 2, 01 in total, administered on 16-DEC-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-DEC-2021, the patient administered expired vaccine (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220210382, 20220260967, 20220261011, 20220261063, 20220261042, 20220261024, 20220261000, 20220261092, 20220261014 and 20220261030.
Client began to feel clammy and said he felt lightheaded. While seated he lost consciousness. He was laid on the floor with feet elevated on a chair and regained consciousness. He was out for less than 30 seconds.
Weakness, headache, vomiting, severe gastrointestinal reaction. Severe headache for three days resulting in taking Monday off of work. Weakness persisted for three additional days.