chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a company representative referring to a 25 year old female patient.  No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was supposed to receive a dose of VARIVAX but accidentally was vaccinated with a dose of ZOSTAVAX (wrong drug administered), subcutaneously, for prophylaxis (dose, frequency, lot number and expiration date were not provided) (product use issue). No product quality complaint (PQC) was involved. Additional information has been requested.
Dizziness 150/96, HR 88, O2 97%, BS 104 9:30am Patient reported that she is feeling much better. After EMS recommended if feeling any symptoms to call 911 or contact primary, understanding verbalized.
rash @ inj site;nausea & stomache pains-reminents of rash 6mo later;
Dizziness primarily after getting home. I got out of my car and stumbled. But I made it into the house after that. I went into the bathroom and stumbled trying to sit on the toilet. I just don't get like this. After a while I was able to eat some supper. Early in the evening, I got very tired. I woke up at around 2:00 in the morning with no real explanation why; but after I woke, I just started shivering really, really badly. I have only ever done that when I was actually sick with the flu. By 07:30 this morning, I was running 102.2 fever. I was still shivering every time I took the blanket off. But I could tell it felt like a sauna under the blanket. My head was and is pounding. Every joint in my body feels achy and awful. I threw up. I kept dry heaving every time I tried to get up. I cannot raise my left arm. It is excruciating and painful. My eyes feel hot. And then I get shivery. And I'm sleepy! I called my doctor and notified him of every one of my symptoms. He said that the inability to function or think or go to work or do anything with this vaccine was normal.
pt recv vax 13JAN98 & 26JAN98 pt devel approx 30 lesions, some fluid filled & some red dots;also exp cold dx & was cranky;
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 19-APR-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength and route were unknown) (lot# reported as No14633 which was verified as not valid and expiration date reported as 07-NOV-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
My husband's face swelled up. The right side of his face around his nose including his lips. It happened suddenly with no warning. He had been feeling ok but that morning experienced sudden onset of severe pain in his hip. He had taken ibuprofen for the pain a few hours before the swelling in his face happened. He has never had any reactions to ibuprofen. He has no known allergies. Nothing like this has ever happened to him before.  The swelling got worse overnight but during the following day the swelling started to go down. By that night it had gone down completely. Now he is fine but his lips look a little bruised, However, now we don't know if he should get the second vaccination which is scheduled on the 30th April. We did not contact a Dr.
Aches, pains, sweats, fever 103.5, extreme fatigue, coughing and shortness of breath .  Two days after vaccine, visited Walk in. No tests given, diagnosed with stomach virus. Coughing continued and was seen by Dr., pulmonologist, was diagnosed and treated for pneumonia  - Feb. 7, 2023.
Lump on right hand is the size of a small egg; LUMP ON BOTH HANDS; This spontaneous case was reported by a consumer and describes the occurrence of MASS (LUMP ON BOTH HANDS) and MASS (Lump on right hand is the size of a small egg) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced MASS (LUMP ON BOTH HANDS). On 23-Mar-2021, the patient experienced MASS (Lump on right hand is the size of a small egg). At the time of the report, MASS (LUMP ON BOTH HANDS) and MASS (Lump on right hand is the size of a small egg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not included. Treatments included ice packs to short-term antibiotics.   This case was linked to US-MODERNATX, INC.-MOD-2021-083074 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083074:case for first dose
This spontaneous report as received from a 61 years old consumer refers to herself with no medical history or drug allergies. On approximately 13-JUN-2013 "about two weeks ago" the patient was vaccinated with 0.65ml dose of ZOSTAVAX, subcutaneously. Concomitant therapies included celecoxib, NEXIUM and nefazodone. On approximately 13-JUN-2013 "about two weeks ago", the patient had a small injection site rash, that was "itchy", this occurred the day after receiving ZOSTAVAX. The patient did not seek medical attention. The outcome of the event was reported as completely recovered in June 2013. Additional information is not expected.
2-month-old baby was administered a hip shot of an expired ACTHIB with no adverse event; Initial information received on 16-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old and unknown gender patient who was administered a hip shot of an expired HIB (PRP/T) Vaccine [ACT-HIB] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an expired dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot UJ836AA, Expiry date: 20-10-2023 with unknown strength) via unknown route in unknown administration site as immunization with no adverse event (expired product administered) (latency: same day).   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.
This spontaneous report as received from a physician refers to an 18 year old female patient. On 28-JUL-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K004148, expiration date 10-MAY-2015) (dose unspecified), intramuscular. On 28-JUL-2014, the patient experienced redness, tingling and burning at the injection site, that radiated to the hand, after receiving PNEUMOVAX 23. The patient sought medical attention via office visit on an unspecified date. Steroids (unspecified name, dose/frequency and manufacturer) were given for treatment. The events outcome was reported as recovered/resolved. Additional information has been requested.
REDNESS, SWELLING & PAIN AT INJECTION SITE OF RIGHT DELTOID.
1 day after first Covid-19 vaccine patient developed fever, chills, then chest pain,,12 lead showed 1mm  ST elevations laterally with cardiac ultrasound showing mild global hypokinesis of the left ventricle and an EF of 40%
Hives 1 day post influenza vacc. Referral to Allergist. BENADRYL 1-1 1/2 tabs q 6 hours PRN.
Flu vaccine was administered without proper consent from patient's POA. Patient resides in long term memory care unit and was unable to verify which vaccine she was choosing to receive. Both COVID booster and flu shots were being administered and nurse noted patient was to only receive one vaccine and did not double check which vaccine prior to administering. Staff mentioned the flu shot and therefore that is what was administered. Nurse noted error upon signing off on administration. Patient's daughter/POA, was called after error was discovered and stated that patient has never received the flu vaccine only by choice and does not have known allergies to vaccine. Also states it was only to due to personal preference that she never received the vaccine before. Daughter was not upset about the administration of the vaccine and patient had no visible adverse reaction in the monitoring period of 15 min post administration.
He is not right; Flushed, red in face; Red in face; Horrible headaches; Given the booster dose of the Moderna vaccine under 3 months from 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Given the booster dose of the Moderna vaccine under 3 months from 2nd dose), MALAISE (He is not right), FLUSHING (Flushed, red in face), ERYTHEMA (Red in face) and HEADACHE (Horrible headaches) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   In September 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Given the booster dose of the Moderna vaccine under 3 months from 2nd dose). On an unknown date, the patient experienced MALAISE (He is not right), FLUSHING (Flushed, red in face), ERYTHEMA (Red in face) and HEADACHE (Horrible headaches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. On 29-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Given the booster dose of the Moderna vaccine under 3 months from 2nd dose) had resolved. At the time of the report, MALAISE (He is not right), FLUSHING (Flushed, red in face), ERYTHEMA (Red in face) and HEADACHE (Horrible headaches) outcome was unknown.            No concomitant medications were reported
Dr.  used these terms: brachial plexitis or acute brachial neuritis and Parsonage-Turner Syndrome. Literature on both seem to totally match up with my experience. I got my shot on Thursday, October 18. In the next hours the pain spread down my arm, worsened, and then by 1am th next morning, was severe. I went to the ER - had x-rays, blood work, given pain pills. It was predicted to lessen in a week. However, the pain persisted and made me unable to sleep, even with the pain pills. Additionally, my right pointer finger went totally numb. So after a week, I saw my PCP. He said there was nerve damage, and he wanted me to totally rest my arm in a sling to let the nerves start to heal and assess in a week more. At the next week's appointment, I was not better and he referred me to the neurologist, Dr., who I saw the next day (November 2.) He quickly diagnosed it. He said the brachial plexus was very inflamed, causing the pain and damage. He described it as a fairly rare "auto-immune" reaction to the flu shot that required an immediate high dose of steriods, physical therapy to maintain mobility and strength and monitoring. A "nerve mapping" is scheduled for November 28. He said that some of the damage may be permanent. He said the present goal was to work through the pain, avoiding further complications of guarding a painul area, a potential of something he called RSD. I started a course of physical therapy at Rehab yesterday, November 12. 11/30/07 Reviewed medical records from neurologist which reveal patient experienced pain & sensory change in RUE x approx 3 weeks.  Initially injection site had a tender bump & then pain traveled downward to distal aspect of RUE & had intractable pain & sensory loss of right index finger since then.  Difficulty sleeping due to pain.  Had received previous flu shots w/o problems.  Had been seen in ER on 10/21.  CBC, chemistry & shoulder x-ray WNL.  Exam revealed stiff tender c-spine musculature; tenderness of right axilla; abduction & extension of right shoulder caused pain; & entire RUE was dusky in dependency.  RUE musculature was weak w/reduced sensation of right index finger.  Reduced RUE reflexes.  Tx w/steroid tapering dose.  Referred for CXR & EMG/NCS, PT/OT.   FINAL DX: post vaccination right brachial plexitis, presumably with an autoimmune mechanism.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), PYREXIA (102 F degree fever) and FATIGUE (feel tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm), PYREXIA (102 F degree fever) and FATIGUE (feel tired). At the time of the report, VACCINATION SITE PAIN (sore arm), PYREXIA (102 F degree fever) and FATIGUE (feel tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) high units: degrees F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
PAINFUL MIGRAINE HEADACHE; LIPS NUMB; CRAMPS ON EYES MOUTH AND FINGERS; FINGER NUMB; STRONG HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUL-2021, the subject experienced painful migraine headache. On JUL-2021, the subject experienced lips numb. On JUL-2021, the subject experienced cramps on eyes mouth and fingers. On JUL-2021, the subject experienced finger numb. On JUL-2021, the subject experienced strong headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the strong headache, painful migraine headache, lips numb, cramps on eyes mouth and fingers and finger numb was not reported. This report was non-serious.
pt recvd vax 1FEB94 & 4FEB94 930AM pt fell down from walking fever noted; minute later started shaking, rolling eye balls, stiffness of arms & hands, cyanotic; brought to ER t104.7; APAP given; CSF & blood work result neg x/pending CXR
Headache Left arm pain Narrative: 12/29 - onset of left arm pain. 12/30- onset of headache. 12/31 headache still present but improve. Arm is mildly sore - much better
Upon returning home patient noticed immediate bruising at injection site. The bruising enlarged as well as swelling and area of redness around vaccination site. The patient said that the vaccine hurt upon administration. Patient presented to pharmacy on 10-10-2023 the arm was still bruised, with a red raised surrounding that was hot to touch. Patient also said the area itched after administration. Pharmacist advised patient seek advice of physician.
slight rash where I got my vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (slight rash where I got my vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (slight rash where I got my vaccine). At the time of the report, VACCINATION SITE RASH (slight rash where I got my vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   Reporter did not allow further contact
Urticaria starting 10 days after 2nd and 3rd dose of Moderna. Angioedema after 2nd dose.
"Covid Arm".....large red itchy rash at injection site appeared on day 7 and continues now day 10
PT INDICATED HER ARM HAS A BIG BUMP ON IT, AS IT IT WAS SWOLLEN. IT IS VERY HOT TO THE TOUCH, AND HAS BEEN PUT ICE ON IT
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M020101, expiration date: 07-MAR-2019) (dose and route of administration were not reported). There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of the two reports received from the same reporter. As of 22-NOV-2016 all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA004057: MERCK 1610USA004025:Mfr number.
Skipping beats; heart rate went to 100 or over at rest; Headache; loud ringing ING ears; Dizzy; This is a spontaneous report from a contactable consumer (patient herself). A 52-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-  EW0172) via an unspecified route of administration in left arm on 18May2021 12:30 as 1st dose, single dose for COVID-19 immunization. Patient was 52-years-old and was not pregnant at the time of vaccination. Patient medical history included Raynaurds, active TB, Allergic to sulfa, penicillin, tetracycline, erythromycin, experienced drug reaction due to prednisone, alleve (muscle relaxants), allergies to antibiotics, latex and wasp, had shoulder surgery after which used cold medicines, was not getting another, COVID-19 in Nov2020. The concomitant medications included birth control, pseudoephedrine hydrochloride (SUDAFED 12-HOUR). Facility where the most recent COVID-19 vaccine was administered was reported as Doctor office/urgent care. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. On 19May2021 at 10:00, patient experienced headache, loud ringing in ears, heart rate went to 100 or over at rest and was skipping beats and was out of rhythm, dizzy. She read studies from country that shows 1 shot for those who had covid is same as having 2 shot. She still was testing that she had antibodies. All she could do was drink water and wait till she metabolized whatever set her system off. She did not want go through that again. Device date was reported as 21May2021. Adverse events did not result in hospitalization. The outcome of the events was resolving.
SWELLING, TENDERNESS, AND TINY LUMP TO LEFT AXILLA;  APPT. MADE WITH HER DOCTOR
swelling of entire lt proximal arm 4cm greater than rt arm;area of induration & bruising 5cm x 4.5cm of lt proximal arm;erythema of lt proximal arm;
Information has been received from a female RN who on 4/11/00 was inadvertently splashed on the side of the face with a small amount of Hep-B vaccine. It was noted that the vaccine did not enter the eye. Two days later, on approx. 4/13/00, the pt experienced redness and swelling of the site. It was noted that it appears to be cellulitis. The nurse completed the series with Hep-B vaccine and is immune. Unspecified medical attention was sought. Additional information has been requested.
Fever, chills, arm pain, body aches, fatigue, stomach pains, these symptoms were mild the day after the vaccine and then worse 2 days after the vaccine on the 15th
This spontaneous report has been received from a registered nurse referring to patient of unknown age. On approximately 01-JAN-2015 (about two weeks ago) the patient was vaccinated with improperly stored GARDASIL (dose and route unknown). No adverse effects were reported. Additional information has been requested.
Myelitis transverse; shingles; immunodeficient; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a male patient of an unspecified age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around 03-SEP-2014, the patient was vaccinated with a dose of vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after to patient's inoculation, the patient suffered paresthesia and numbness in lower extremities and hypersensitivity in the midthoracic region resulting in a diagnosis of transverse myelitis; additionally, the patient became immunodeficient and was also diagnosed with shingles. As a direct and proximate result use of the vaccine live (ZOSTAVAX) vaccine, the patient's had resulted in physical limitation not present prior to vaccination, The patient had also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  At the time of the report, the outcome of  myelitis transverse, shingles (herpes zoster) and immunodeficiency were not recovered. The reporter considered the events previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review the events myelitis transverse was considered as medically significant.
Congestion in chest, coughing, hoarse. Took mucinex.  Sudafed.  Drank tea with honey. Still have congestion today (11/16/2021)