chrisvoncsefalvay/vaers-outcomes huggingface dataset:
WITHIN 48 HOURS OF INJECTION, UPPER RESPIRATORY INFECTION FAILED TO RESOLVE AND CONTINUED TO PROGRESS, AND NEW SYMPTOMS ONSET AT 48 HOURS EXACTLY, INCLUDING INTRACTABLE VOMITING WITH DEHYDRATION REQUIRING ASSESSMENT AND EVALUATION AND TREATMENT (INCLUDING MEDICATION) IN AN EMERGENCY DEPARTMENT.
Information has been received from a physician and a nurse concerning a 61 year old male patient who on 08-JUL-2009 was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot number not reported). It was reported that on approximately 14-JUL-2009 the patient developed encephalitis after the vaccination. The patient was admitted to hospital on 14-JUL-2009 for the encephalitis. At the time of the report, the patient had been home for a while and was doing better. The physician didn't known if the patient's experience had anything to do with the vaccine. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 04-FEB-2015, the patient was vaccinated with MMR II (lot number: K002816 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with MMR II, live was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Stiffness over the body plus injection arm; slept for 12 straight on Friday; slept for 24 hours on Saturday; getting a little now except for sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness over the body plus injection arm), SLEEP DISORDER (slept for 12 straight on Friday), HYPERSOMNIA (slept for 24 hours on Saturday) and SOMNOLENCE (getting a little now except for sleepiness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness over the body plus injection arm), SLEEP DISORDER (slept for 12 straight on Friday), HYPERSOMNIA (slept for 24 hours on Saturday) and SOMNOLENCE (getting a little now except for sleepiness). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness over the body plus injection arm) was resolving and SLEEP DISORDER (slept for 12 straight on Friday), HYPERSOMNIA (slept for 24 hours on Saturday) and SOMNOLENCE (getting a little now except for sleepiness) outcome was unknown.            Patient stated that The second vaccine was not as bad as the first.  No concomitant medications were provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-264281 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Additional information was received on 22-JUL-2021 contains patient's demographics (gender and initials) and dose 2 information.
On 1/18/22 had my annual physical and CBC showed platelets going from 274 to 80 , platelets continue to drop after monthly testing and was referred to a hematologist continue to have issues with low platelets, bleeding and bruising . Recent blood work now has liver functions high 1/20/23 and being followed with testing by gastroenterologists. I had no issues prior to the Covid vaccinations.
Information has been received from a nurse concerning a male patient who on 07-JUN-2010 was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot #664627/0876Y). On 10-JUN-2010 the patient developed hematoma in the arm and a classic shingles rash across the trunk. The patient sought unspecified medical attention. there was not lab test performed. At the time of this report, the patient's outcome was unknown. The reporter considered hematoma in the arm and a classic shingles rash across the trunk as other important medical events due to intervention to prevent serious criteria with VALTREX. Additional information has been requested.
I had intense nausea, no appetite with a low-grade fever with chills. I was warm to the touch with a headache. I felt achy all cover with a cough. My pulse was faster than usual, and I was very lightheaded. I was very irritable.
Pfizer 1st dose on 3/20/21 (Lot # ER8731)   Pfizer 2nd dose on 4/10/21 (Lot # EP6955)   On 4/12/21 pt came to ER complaint of feeling depression and not wanting to wake up. Husband stated that on the car riding to Hospital, patient made verbal comments of ?banging head? or ?finding a knife? as a mean of ending life. Patient was tearful on arrival. It was not sure if this related to COVID vaccine, but we report for record keeping.
was thought he was having a stroke; acutely aphasic / patient remained aphasic for 48 hours /Patient was hospitalized; This case was reported by a physician via call center representative and described the occurrence of aphasia in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced aphasia (serious criteria hospitalization) and stroke (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the aphasia was recovered/resolved and the outcome of the stroke was unknown.   It was unknown if the reporter considered the aphasia and stroke to be related to Shingrix.  Additional case details were reported as follows: The patient was reporter's friend. The age at vaccination was not reported. The reporter stated that the patient who received a Shingrix vaccine was not a personal patient. A week after the first dose of Shingrix vaccine patient became acutely aphasic and was thought he was having a stroke. The patient hospitalized. The reporter stated the patient remained aphasic for 48 hours. Gradually improving after 36 to 48 hours. Patient was still in the hospital. The reporter consented to follow up. This case has been link with case US2020AMR217355, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR217355:same reporter
When I received my Covid 19 vaccine, the person giving the shot said she would go above my hormone patch that I wear on my arm. Since then, I have been experiencing severe sharp pain in my left shoulder and shoulder blade. I believe the shot was in the joint.
A non-serious spontaneous report of strep pneumonia symptomized by fever, reactive airway disease symptomized by cough and runny nose has been received from a company representative/non-health professional concerning a six-year-old female patient, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received dose of FLUMIST on 01-Oct-2010 for an unknown indication. On 03-Oct-2010, the patient had runny nose, fever and cough. Symptoms developed into reactive airway disease. The patient was taking albuterol and fluticasone at the time of report. The patient was also diagnosed with strep pneumonia. The outcome of the events strep pneumonia symptomized by fever, reactive airway disease symptomized by cough and runny nose was unknown.
This spontaneous report as received from a registered nurse refers to 2 female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 28-JUL-2015, the patients were vaccinated with their first doses of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). On 12-JAN-2016, the patient were vaccinated with their second dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). On 01-FEB-2016, the patients were vaccinated with their third doses of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). There was no adverse effect reported. Additional information has been requested.
Information has been received via The Poison Control Center and from a consumer concerning her daughter, a 15 year old female, who on 12-APR-2007 was vaccinated with Gardasil. It was reported that on Friday, 13-APR-2007 and over the weekend, the patient experienced being very tired and developed puffy eyes. On May, approximately, 16-APR-2007, the patient's eyelids started getting puffier. On Tuesday, approximately 17-APR-2007, it was reported that the patient had increased puffiness of eyelids. On Wednesday, 18-APR-2007 the patient developed face swollen and was seen by ("ENT"). On Friday, 20-APR-2007 the patient was seen by the primary care physician (PCP) and had developed rash and hives. At the time of the report, the patient had a fever of 102 and increased rash and hives. It was recommended that the patient go to the Emergency Room (ER) for an evaluation. At the time of the report, it was unknown, if the patient recovered. Additional information has been requested.
Swelling and itchiness at injection site.  Within 48 hours, swelling and redness had grown to a 3" diameter and patient became achy and sick feeling.  By 60 hours, the achy and sick feeling passed and swelling and redness began to recede.  Redness and swelling now 1".
Narrative: 66yo male patient died at outside hospital on 10/15/2021 after had self-presented to community emergency facility on 10/13/2021 for syncopal episode at home and hypotension. No other info available regarding circumstances of pt's death. Medical history:PROBLEM LIST: Sleep disorder (SCT 39898005) CVA - Cerebrovascular accident (SCT 230690007) Viral hepatitis C (SCT 50711007) Hypercalcemia (SCT 66931009) Impaired Fasting Glucose (ICD-9-CM 790.2Hepatitis C antibody test positive (SCT 314706002) Other and unspecified alcohol dependenceCocaine dependence (SCT 31956009) Psychoactive substance-induced organic mSuicidal (SCT 267073005) Alcohol abuse (SCT 15167005) Cocaine abuse (SCT 78267003) Hyperkalemia (ICD-9-CM 276.7) Hyperlipidemia (SCT 55822004) Hematuria (SCT 34436003) Benign essential hypertension (SCT 1201005) Hyperlipidemia (SCT 55822004) Liver function tests abnormal (SCT 166603001) Health Maintenance (ICD-9-CM V65.9) Pneumonia (ICD-9-CM 486.) Tobacco use (SCT 110483000) Pt had received covid vaccines at agency hospital on 3/19/21 & 4/11/21. Likely this death is not related to covid vaccines given patient's age, comorbidities, and long length of time between date of vaccines and date of death.
Patient did not have any adverse events .  She was supposed have been given her 4th DTaP,  but was given the Tdap instead.   Patient was monitored/observed for 20-25 minutes after injection was given and did not display any adverse reactions.
swollen and painful lymph nodes since the beginning of June, she's wondering if this a late reaction to the vaccine
This case was reported by a consumer via call center representative and described the occurrence of shivers in a 51-year-old male patient who received SHINGRIX (batch number ZY3X4, expiry date April 2019). Concomitant products included Omeprazole, LEXAPRO and Toprol. On 17th May 2018, the patient received SHINGRIX (intramuscular). On 18th May 2018,1 days after receiving SHINGRIX, the patient experienced shivers, shoulder pain, pain and influenza-like symptoms. On an unknown date, the outcome of the shivers, shoulder pain, pain and influenza-like symptoms were recovering/resolving. It was unknown if the reporter considered the shivers, shoulder pain, pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The next day after vaccination, the patient experienced shivers at night and flu like symptoms which included achiness, shoulder hurts. The patient said that he was feeling better today but he was still having symptoms.
HX VASOVAGAL EPISODE. AFTER RECD J AND J VACCINE, EYES ROLLED, UNRESPONSIVE X 30 SECS, THEN BECAME RESPONSIVE, BP 106/76 HR 59. CODE GREEN CALLED, SX RESOLVED, NO TRANSPORT.
Localized-at site of injection-red, swollen, warm to touch. 4 inch oval-hard, not sore. Headache-excruciating, back of neck up to crown - sporadic nausea. Lasted 8 days. Neck muscle tenderness. External ear  pain - jaw pain.
The day after the injection, the injection site hurt, the right shoulder.  Applied ice.  Three days after injection, contacted Family Practice doctor (Dr .  Told to take it easy and apply ice.  Pain continued 6-7 days after injection.  Attempted to get office visit with Dr .  Not available that week, so I made an appt with my orthopedic surgeon.  Appt on 10/21/2021.  Diagnosis was bursitis.  Received cortisone injection into bursa.  Took it easy for a week and pain subsided.  Two weeks after the shot, the pain was significant.  Made another appt with another dr.  MRI on 11/12/21 and office visit with 2nd dr on 11/15/21.
a patient was adminitered Pentacel vaccine which was exposed at below 30-32 F for one hour due to opening and closing of refrigerator door/No AE; Initial information was received on 19-Jun-2020 regarding an unsolicited valid non-serious case received from a physician.  This case is linked with cases 2020SA161184, 2020SA161064, 2020SA161181, 2020SA161182 and 2020SA161203 (same reporter).  This case involves a five months old female patient who was vaccinated with a 0.5ml second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was exposed at below 30-32 Fahrenheit for one hour due to opening and closing of refrigerator door (lot number: UJ015AAA and expiry date 26-OCT-2020) via intramuscular route in the left thigh on 08-Jun-2020 for prophylactic vaccination  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was a case of an actual medication error due to product storage error temperature too low.  At the time of reporting, no adverse event was reported.  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 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.
Acute allergic reaction Tongue swelling Facial swelling  Throat swelling Rash on throat and chest Redness in throat Diaphoresis Momentary loss of consciousness
Hypertension 1 month after up to 4 months later, extreme period pain, a week late.
PT received MMR and IPV vaccination at 10:15 at 10:17 patient became tense and passed out. Pt awoke shortly  there after fully alert patient stated he understood what had  happened. Pt vomited twice 10 minutes apart. Patient was taken to Immunizations nurse after 30 minutes of 1:1 monitoring. Patient was taken to undersea medicine to be seen by provider.
Fever, chills, body aches, dizziness, nausea, headache, fatigue, sore arm at vaccine site, sore lymph nodes in arm pit closest to vaccine site from 1 am until time of reporting (Sun evening). Ibuprofen every 4-6 hours reduced intensity of some symptoms
Flu-like Symptoms; Weakness; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and weakness. On an unknown date, the outcome of the influenza-like symptoms and weakness were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and weakness to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient experienced weakness and flu-like symptoms for 2 days after receiving Shingrix.
pt recvd vax & exp inject site rxn; rxn included redness, pain & swelling;
4 hrs post vax pt devel fever 103, muscle weakness, nausea, dizziness; weakness worsened over next 24 hrs so that pt could not walk; temp would not reduce w/APAP or cool baths; pt taken to ER 9APR93; MD in ER stated poss reaction to vax;
This spontaneous report was received from a registered nurse and refers to a 5 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 13-DEC-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown), lot # M015735 with expiration date of 30-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 77 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Covid-19 rapid test came back positive; Covid-19 rapid test came back positive; chills; fatigue; cough; congestion; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 37 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "unknown" and all described as "Covid-19 rapid test came back positive"; CHILLS (non-serious) with onset 29Dec2021, outcome "not recovered", described as "chills"; FATIGUE (non-serious) with onset 29Dec2021, outcome "not recovered", described as "fatigue"; COUGH (non-serious) with onset 29Dec2021, outcome "not recovered", described as "cough"; PAIN (non-serious) with onset 29Dec2021, outcome "not recovered", described as "body aches"; NASAL CONGESTION (non-serious) with onset 29Dec2021, outcome "not recovered", described as "congestion". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive. Clinical course: On the evening of 29Dec2021 patient became quickly I'll with chills, fatigue, cough, body aches, and congestion. The morning of 30Dec2021 patient work up not better and went for a Covid test. Patients Covid-19 rapid test came back positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
About 15 minutes after receiving the 2nd dose of the Hepatitis B vaccine, I developed an itchy rash on both arms, across my chest, backs of my shoulders, and face.  Over the next few days my symptoms worsened and the rash went from itchy to burning all over my body.  I also developed a headache, dizziness, sore itchy swollen throat, and chest pain as well as sensitivity to light.
This spontaneous report as received from a nurse practitioner refers to a male patient of unknown age. On 12-AUG-2014 the patient was vaccinated with a dose of GARDASIL (lot#, route unspecified, dose/frequency reported as directed in the prescribing information). Concomitant medications were unspecified. On 12-AUG-2014 the patient fainted after receiving GARDASIL. No treatment was given for the adverse event. The patient had sought medical attention by office visit on an unspecified date. Outcome of the event was not reported. Additional information has been requested.
Patient had a vasovagal response within 5 minutes of receiving vaccination. Patient was in the waiting room and notified by friend. Patient was pale, diaphoretic, unresponsive, extremities tremoring and incontinent of urine. Cool compress held to forehead and neck. Cold fluids given. Vitals taken. Patient transported to vehicle in wheelchair. Friend drove home. Instructed to go to ED if symptoms have not improved. She stated she has had episodes like this in the past with vaccinations/blood draws.
Pt recv vax on 7/10/97; 2-3 wk later pt exp hair thinning. Dermatologist dx=stress related
Fatigue, lethargy, body aches, joint paint, headache, brain fog, nausea w/o vomiting
Individual scheduled for a Second dose Pfizer/BioNTech on 01/31/22 after receiving first dose Moderna on 12/16/21. Patient was administered Pfizer/BioNTech 0.3 ml IM in Left Deltoid on 01/31/22.
Skin abscesses in left armpit. 3 appeared about 6 days after my 2nd vaccine shot. They were extremely painful and required incision and drainage. Currently on antibiotics and they are still present.
Fluid filled blister at site of injection on left deltoid. Blister approx. 1 cm by .5 cm in oval shape.  Blister began turning red & purple by 6/5/11 and was accidentally scrubbed open during a shower that evening... white & red dotted open abrasion remained. Covered by bandage since it was first discovered. No other symptoms have arisen but monitoring the situation. Showed blister to the pediatrician's office, but they showed a complete lack of concern.
DOWN IN BED/BED-RIDDEN; TIGHTNESS IN CHEST; WINDED TO WALK; COUGH; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAY-2021, the subject experienced tightness in chest. On MAY-2021, the subject experienced winded to walk. On MAY-2021, the subject experienced cough. On 07-MAY-2021, the subject experienced down in bed/bed-ridden. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from winded to walk, and the outcome of tightness in chest, cough and down in bed/bed-ridden was not reported. This report was non-serious.
Within 10 days extensive Red, Scaling Rash, arms, Legs, trunk, painful burning. Led to Hospital visit- COVID19 Pneumonia, Flu, Pulm Embolism, AFIB