chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Person fainted lossing consicousness for several minutes following vaccination during the 15 minute monitoring period. As he fainted he hit his forehead on the ground . Reportedly very nervous about getting the vaccine, had taken cannibas before getting vaccinated to help decrease his anxiety.  His diastolic blood pressure was low initially. His O2 saturation decreasedo about 88 percent as he started to develop more anxiety after rising from laying to sitting.
Chicken Pox Shot given 11/8/07 presented today 11/9/07 with 2cm x 2.5cm indurated increased warmth at site
Hives on stomach, chest, back, not itchy. Smaller than penny. No SOB, no tongue numbness or swelling. No other symptoms. Advised to take antihistamine, go to ER if any SOB, tongue swelling.
Abdominal pain 5/31/14 -> went to ER. Diagnosed with intussusception of colon. Corrected by barium enema.
infant Moderna Bivalent given for 2nd dose of series.  Pt received monovalent for 1st dose in series
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age. On an unknown date the patient was vaccinated with MMRV lot number J005178; expiry date 03-NOV-2014 and lot number J004174; expiry date 08-OCT-2014. No concomitant medications were reported. The nurse reported that MMRV lot number J005178; expiry date 03-NOV-2014 and lot number J005178; expiry date 03-NOV-2014 and lot number J004174; expiry date 08-OCT-2014 was exposed to -2.5C for 252 hours and was administered to unspecified number of patients. No adverse effects were reported. This case is linked to case # 1401USA000286 and 1401USA000288 (same reporter link). Additional information has been requested.
Approx 5 mins past vaccinations with FLUARIX and BEXSERO. Patient stated she didn't feel well. She stated she felt like she was having a seizure then became syncopal with posturing. Regained consciousness within seconds. O2 Sat 100% with strong reg pulse. 911 called. Paramedics/transferred-pt declined ER visit. Fully alert, aware, stable at transfer.
No adverse event; Expired dose of GARDASIL 9 was administered to a patient; This spontaneous report was received from a Licensed Practical Nurse regarding a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.   On 21-DEC-2021, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml for prophylaxis, lot number S004578 with expiration date on 29-SEP-2021 (strength, dose number, anatomical location and route of administration were not reported). No adverse event was reported.
arm was a little sore at the injection site; not able to sleep on left side; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm got pretty sore), INSOMNIA (not able to sleep on left side) and VACCINATION SITE PAIN (arm was a little sore at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (arm got pretty sore) and INSOMNIA (not able to sleep on left side). On an unknown date, the patient experienced VACCINATION SITE PAIN (arm was a little sore at the injection site). In February 2021, PAIN IN EXTREMITY (arm got pretty sore) and INSOMNIA (not able to sleep on left side) outcome was unknown. At the time of the report, VACCINATION SITE PAIN (arm was a little sore at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-241651 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up information received on 30 Jun 2021. New event added.
Itchy rash of small red bumps on upper chest and arms where sunscreen and sun exposure had occurred. Rash proceeded to outer ears and neck, then spread down middle of back (no sunscreen or sun exposure occurred on back. Itch continued for more than 4 weeks. Self-treated extensively with 2% cortisone cream. After itch resolved, small red bumps reduced to lesser bumps of normal pigmentation. Bumps remain on arms and back.
This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored RECOMBIVAX HB.  No adverse symptoms reported. At the time of the report the action taken was not reported.  All telephone attempts to obtain follow-up information have been unsuccessful.   Follow up information was provided by the register nurse refers to a 1 day female patient. Current conditions and concomitant medications were not reported. On 09-JUL-2014 at 10:58 AM, the patient was vaccinated with an improperly the first dose of RECOMBIVAX HB (Thimerosal Free) intramuscular, lot number J012520 and expiry date 30-JAN-2016). On 09-JUL-2014 at 10:58 AM, the patient received the RECOMBIVAX HB stored to 0-1 degree of temperature x18 different episodes, according to minimum/maximum. All recorded temperature were within 2-8 degrees. The issue that occurred was that they had a temp of 0-1 degrees on 18 different episodes between May 14th and July 21st, they were not able to identify how long the temps were down because it was not documented accordantly. They knew that when the temps were checked each AM and each PM they were within the normal 2-8 degrees. The vaccine was removed once problem was  identified and was not been used after 21-JUL-2014. This is one of several reports received from the same reporter. Additional information is not expected because all follow up information was received.
5 days after receiving the flu HD vaccine in the evening I started having ringing in my ears. Lasted about a minute and I could not get them to stop. Ever since having the shot I having the intermittent ringing in both of my ears. I contacted ,my PCP and he stated that I should contact the VAERS report and report the symptom. I will be seeing my PCP 2/2/21
pt called c/o vomiting, h/a, low fever p/inject #2; pt states had exact same problem w/1st inject same time frame; pt assumed coincidentally ahd the flu p/1st shot but when if recurred p/2nd pt reported it;
On March 1, 7 days after accidentally touching her son's smallpox vaccination site pustule, started running high fever (101), and headache.  One day later macular rash in trunk and arms lasting 24 hours.  Fever and headache continued for 4-5 days.  She observed 2 round red lesions on the third day of fever, located in the chest right under the breast (one left and one right) painful initially but then very itchy, 2x2 cm, with what looked a pustule in the middle.  When we actually explored the patient, the lesions where 1x1 cm with a tiny pustule (4mm) in teh middle and had no fever anymore.
A 5 month old infant received a 2nd dose of Prevnar. Subsequently, the infant was hospitalized with a diagnosis of pneumococcal meningitis. No further info was available at the date of this report. Follow up info received from the physician on 07/23/01, indicated that a 5 month old female received an injection of Prevnar on 05/16/01. On 05/28/01, the child was hospitalized and diagnosed with pneumococcal meningitis. Blood and cerebral spinal fluid cultures were positive for Streptococcus pneumoniae. Gram positive cocci were seen in a gram stain of cerebral spinal fluid. A bacterial antigen panel was positive for Streptococcus pneumoniae. Lumbar puncture results on 05/28/01, showed white blood cells at 50/ cu mm, total protein of 329 mg/dl., neutrophils at 46 %, bands at 37 %, Lymphocytes at 15 % and monocytes at 1 %. The infant recovered.
Vaccine inadvertently given to patient at age 17 years old. Moderna vaccine not authorized in this age group; No other adverse events or side effects reported
Patient has never had eczema in his life before; Patient developed a general rash complete body rash after the vaccine/He had a complete body rash all over except for his face/He was breaking out in patches; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Patient developed a general rash complete body rash after the vaccine/He had a complete body rash all over except for his face/He was breaking out in patches) and ECZEMA (Patient has never had eczema in his life before) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 011LZ014) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Levaquin).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced RASH (Patient developed a general rash complete body rash after the vaccine/He had a complete body rash all over except for his face/He was breaking out in patches). On an unknown date, the patient experienced ECZEMA (Patient has never had eczema in his life before). The patient was treated with PREDNISONE in August 2021 at an unspecified dose and frequency. At the time of the report, RASH (Patient developed a general rash complete body rash after the vaccine/He had a complete body rash all over except for his face/He was breaking out in patches) and ECZEMA (Patient has never had eczema in his life before) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: nothing showed up (normal) nothing showed up.         No concomitant medications reported.  It mentioned that the patient took medical care PCP, visited 3 dermatologists and allergist.  On an unknown date in Jul-2021, the patient was breaking out in patches and by the end of Aug the patient had a complete body rash all over expect for face. Patient visited the doctor in late august got prescribed with prednisone and unspecified antibiotics and the rash was completely gone, but when stopped the treatment the rash came back worse than before so again prescribed with prednisone and same thing happened when treatment stopped the rash came back, patient had an allergy test and nothing showed up, patient was prescribed a sera topical for 2 weeks on back and looks great.
Client stated that she felt like her heart was racing and she had to yawn to get a deep breathe.  She also smelled anesthesia.   The smell lasted until 5:00 on 2/15 the heart racing and finding it difficult to take a deep breathe lasted until 2/17.
Itchy all over the body; Rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy all over the body) and RASH (Rash all over the body) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PRURITUS (Itchy all over the body) and RASH (Rash all over the body). At the time of the report, PRURITUS (Itchy all over the body) and RASH (Rash all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 63-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number 397B5) for prophylaxis.   On 27-FEB-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Severe muscle pain, weakness, brain fog, fever, loss of appetite, difficulty balancing and walking.
The day after I got my shot I had a lot of pain in my arm at the injection site. I was a little fatigued. The pain remained in my arm and is still there currently. My doctor advised me my vaccine may have been injected to high . As a result of the pain I was prescribed an anti inflammatory Diclofenac Sodium 75mg 2xdaily which I have been taking for 2 weeks now.  My doctor also referred me to a physical therapist because he felt there was a possibility of a pinched nerve in my neck. The pain has since moved through my entire arm and through my fingers as well. It feels similar to Tennis arm. It has also caused difficulty with sleeping at night.
Inflammation of the neck,  shoulder and armpit,  Pain on palpation and hot area to the touch
"right after the shot I got really lightheaded, but it went away in a few minutes.  then about 2am (3/10) I started having hard chills, my temperature went up to around 102, I have body aches and headache still.  missed work today"
PATIENT REPORTS DEVELOPING RASH WITH LITTLE RED DOTS ON CHEST; DIARRHEA; PATIENT REPORTS DEVELOPING RASH WITH LITTLE RED DOTS ON CHEST; CHILLS; Sensitive skin; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (PATIENT REPORTS DEVELOPING RASH WITH LITTLE RED DOTS ON CHEST), DIARRHOEA (DIARRHEA), RASH (PATIENT REPORTS DEVELOPING RASH WITH LITTLE RED DOTS ON CHEST), CHILLS (CHILLS) and SENSITIVE SKIN (Sensitive skin) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.  Concurrent medical conditions included Psoriasis (Patients has Psoriasis for years.) and Allergic reaction to drug (Allergic to Benadryl rashes worsen with the use of Benadryl liquid.).   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (PATIENT REPORTS DEVELOPING RASH WITH LITTLE RED DOTS ON CHEST), DIARRHOEA (DIARRHEA), RASH (PATIENT REPORTS DEVELOPING RASH WITH LITTLE RED DOTS ON CHEST), CHILLS (CHILLS) and SENSITIVE SKIN (Sensitive skin). At the time of the report, ERYTHEMA (PATIENT REPORTS DEVELOPING RASH WITH LITTLE RED DOTS ON CHEST), DIARRHOEA (DIARRHEA) and CHILLS (CHILLS) had resolved, RASH (PATIENT REPORTS DEVELOPING RASH WITH LITTLE RED DOTS ON CHEST) had not resolved and SENSITIVE SKIN (Sensitive skin) 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.   No concomitant medications were provided by the reporter. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant followup Outcome of events was updated.
Pfizer covid 19 vaccine. 1st dose Hives for prolonged period of time.  NO shortness of breath or chest pain.  Lungs CTA Taken to ED for Evaluation
PAIN IN LOWER RIB CAGE; BODY ACHE; LOSS OF APPETITE; SLEEP WAS LIMITED; CHILLS; LACK OF ENERGY; HIP MUSCLE PAIN; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included above average health and no daily medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced pain in lower rib cage, body ache, loss of appetite, sleep was limited, chills, lack of energy, hip muscle pain, headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99 and plus. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in lower rib cage, chills, hip muscle pain, and fever, and was recovering from body ache, headache, loss of appetite, lack of energy, and sleep was limited. This report was non-serious.
Information was received from a certified nurse assistance regarding a 12 year old male (as reported) patient who was administered GARDASIL (lot # J008423) injection intramuscular 0.5ml in right thigh on 23JUN2014. The GARDASIL was involved in a temperature excursion. No adverse event was reported. Please see additional information for other cases reported by same provider. Additional information is not expected.
Patient came into our Pharmacy on 10/16/2013 for her annual Flu shot. This immunization was given by RPh. on 10/16/13 about 11am, using our Standard Immunization protocol: (patient and RPh in sitting position, given IM in Left Arm using standard 1 inch needle and syringe). The immunization and standard protocol for post immunization discussion was given by RPH with patient. No questions and everything seemed to go well and patient left our pharmacy. On May 19th, 2014, the patient contacted RX mgr via phone to report some shoulder issues that she believed were from her Flu immunization back in October 2013. Rx mgr and patient then had a discussion regarding details of the events since immunization on 10/16/2013 and her present symptoms. Patient said that she had some shoulder pain right after injection but that was normal for her. About 1 week after injection she started to experience shoulder pain and mobility issues. Her pain and mobility continued to deteriorate on an ongoing basis despite some physical therapy and massage therapy in early months of 2014. She was always hoping that her symptoms would get better so delayed reporting such issues to the pharmacy. Patient then said that she had a doctors appointment scheduled for early June and it was agreed that Rx mgr would do a follow up phone call once patient had seen doctor and had a diagnosis to report. It was agreed that a VAER form could then be submitted if needed. On June 10th, 2014, Rx mgr has a phone discussion with patient after seeing an orthopaedist on June 5th, 2014. Patient said that Dr. had diagnosed her shoulder issues as a condition called "adhesive capsulitis or Frozen Shoulder". Patient was given a Cortisone injection at time of visit. Pain has improved some but shoulder mobility is still very limited. Patient is to do some physical therapy and follow up with doctor in 1 month. At this time, prognosis is unknown. It was decided that RX mgr would report the incident on VAER form today.
48 hours after Booster #2, I developed significant lower leg (calf) pain, with difficulty walking, and inability to urinate.  Eventually, developed incontinence due to too much urine retained in my bladder.  After 5 days, I went to ER and had a foley catheter placed and drained 1500cc of urine.  I tested + for Covid on 03/31/22.  Perhaps it was too soon to get a 2nd booster on 07/15/22?  After 6 days with a foley in place, I went to a  urologist who removed it.  I went 12 days without urinating, and during that time, I self-catheterized.
an expired dose of TENIVAC was given to a patient with no reported adverse event; Initial information received on 27-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 22 years old male patient and an expired dose of tenivac (DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT) was given to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications: None   On 19-Oct-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (formulation, strength: unknown) lot U6831AA, expiration date: 08-Oct-2022 via intramuscular route in the right arm as Immunization.  On 19-OCT-2022 an expired dose of tenivac was given to a patient with no reported adverse event (expired product administered) same day following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event ( an expired dose of TENIVAC was given to a patient with no reported adverse event).  At time of reporting, the outcome was Unknown for the event    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fever; Cough; Backache; Headache; Nausea; dizziness; pain in the right hand; Tiredness; This is a spontaneous report from a Contactable Consumer (patient). A 58-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), at 58 years of age, via an unspecified route of administration on 24Feb2021 16:30 at single dose, in right arm for COVID-19 immunisation. The patient medical history included type 2 diabetes, high blood pressure, factor 5 leiden. Patient was had allergic reaction with cephalexin, tramadol, ibuprofin, peanuts. Concomitant medication included Bactrim (SULFAMETHOXAZOLE, TRIMETHOPRIM). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), at 58 years of age, via an unspecified route of administration on 03Feb2021 16:15 at single dose, in right arm for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 24Feb2021 19:00, the patient experienced fever, cough, backache, headache, nausea, dizziness, pain in the right hand and tiredness. The events were considered as non-serious. No treatment was given for the events. The outcome of all the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Shortness of breath, hives, and itching.  Took benadryl, famotidine, Xyzal at time of reaction.  Also 4 puffs on ventolin. Symptoms slowly improved over 4 hours.  Epiniphrine not administered.
15 min post injection c/o heart racing, rate 160 on watch Skin flush Confirmed heart rate 160 RRT called , pt never LOC Pt stayed 1 hour for observation, heart rate 106.