chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a health care professional on 05 November 2010. A 65-year-old female patient, with a history of increase blood pressure and increased lipids, received in July 2009 an intramuscular injection (site not reported) of DECAVAC, lot number U2024AA. The patient had no known allergies and no illness at the time of vaccination. Her concomitant medications were not reported. The patient developed on an unknown date a large local reaction. The patient had a similar reaction to a flu shot last year (manufacturer unknown). No further information was available as to the type of reaction. The outcome was not reported. Documents held by sender: None.
Patient was sitting in waiting area post vaccination.  A pharmacist from the vaccination area was called over to her because she was not feeling well.  As the pharmacist was speaking with her patient fainted.  Pharmacist was holding on to her to keep her from falling.  I went over and took her BP which was 65/44, pulse 53.  After a few minutes patient regained consciousness and was able to give us her information.  911 was also called. Patient reports a history of severe reaction to Penicillin.  Patient reports history of syncope at eye doctor's office.  Her BP was taken again at 10:20am and was 98/72, pulse 70.   911 arrived and patient chose to be taken to hospital.
This spontaneous report as received from a physician refers to a male patient of unknown age. No information on patient's pertinent medical history, drug reactions or allergies was reported. On 15-JUL-2015, the patient was vaccinated with GARDASIL, first dose, (route of administration, dose, lot number and expiration date were not reported). The patient was then vaccinated with the first, second and third dose of GARDASIL 9 (route of administration, dose, lot number and expiration date were not reported) on 19-AUG-2015, 17-FEB-2016 and 13-JUL-2016, respectively. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
BRIEF OVERVIEW: Admission Date: 9/4/2023 Discharge Date: Sep 6, 2023 Discharge Disposition:  home or self care  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID-19 [U07.1]   HOSPITAL COURSE: 77 y/o male hx of GPA and ESRD on HD who presented with acute encephalopathy due to COVID 19. He was found in his restroom confused. He was brought to ED and found to be COVID positive. CT brain showed mild atrophy but no acute concerns. He was continued on his home HD schedule. His mental status quickly returned to normal. He had no residual deficits. He was able to work with physical therapy and occupational therapy and was deemed safe to return home. He was discharged to home in stable condition.
sudden feeling of motion sickness; disoriented; brain fog / felt more like shit; This spontaneous case was reported by a consumer and describes the occurrence of MOTION SICKNESS (sudden feeling of motion sickness), DISORIENTATION (disoriented) and FEELING ABNORMAL (brain fog / felt more like shit) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced MOTION SICKNESS (sudden feeling of motion sickness), DISORIENTATION (disoriented) and FEELING ABNORMAL (brain fog / felt more like shit). At the time of the report, MOTION SICKNESS (sudden feeling of motion sickness), DISORIENTATION (disoriented) and FEELING ABNORMAL (brain fog / felt more like shit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       water, taking walks used as Treatment
Ringing in ear consistently since April 21, 2021.  Allday/all night.
Swollen painful armpit; arm pit painful; difficult to lift her arm; Passed out; fever of 101 degrees; Inappropriate age at vaccine administration; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 44-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 30th September 2020, less than a day after receiving Shingrix, the patient experienced fever and inappropriate age at vaccine administration. On 1st October 2020, the patient experienced passed out (serious criteria GSK medically significant). On 2nd October 2020, the patient experienced local swelling, axillary pain and mobility decreased. On 2nd October 2020, the outcome of the passed out was recovered/resolved. On an unknown date, the outcome of the fever, local swelling, axillary pain and mobility decreased were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the passed out, fever, local swelling, axillary pain and mobility decreased to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for herself. The patient received her 2nd dose of Shingrix on Wednesday in unknown arm, which led to age at vaccine administration. Within 4 hours, she developed a fever of 101 degrees.  The patient still had a fever although it was not as high. The patient was passed out yesterday and had recovered from that. On day of reporting her arm pit was swollen and painful and it was difficult to lift her arm. The lot number and expiry date was unknown.   This was a medication error with harm. The reporter did not consent to follow up
Erythema multiforme rash started approximately 7/9/07 seen in my office 7/17/07 and diagnosed. No other viral symptoms, not on any medications, not blistering. Continuing to spread down legs; torso lesions or resolving.
2 hours after vaccine.  fever, chills, body aches, headache, insomnia, cold sores on mouth which spread to face, vaginal irritation, nasal discharge
achy; fever; head ache; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYALGIA (achy), PYREXIA (fever), HEADACHE (head ache) and CHILLS (chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), SIMVASTATIN and METOPROLOL for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced MYALGIA (achy), PYREXIA (fever), HEADACHE (head ache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 29-Jan-2021, CHILLS (chills) had resolved. At the time of the report, MYALGIA (achy), PYREXIA (fever) and HEADACHE (head ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Still have a headache after 5 days; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 17Apr2021 at 11:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN); all taken for an unknown indication from an unknown date and unknown if it is ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20Mar2021 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient also received hydrocodone (MANUFACTURER UNKNOWN) and tramadol (MANUFACTURER UNKNOWN); for an unknown indication initiated on an unknown date and experienced drug allergy. On 18Apr2021, it was reported that the patient still had a headache after 5 days. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of event still have a headache after 5 days was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a healthcare worker concerning a child who on an unspecified date was vaccinated with a dose of vARIVAX vaccine and concomitantly with a dose of MMR II. Subsequently the patient died. There was no product quality complaint involved. Additional information was sought, and the reporting healthcare worker indicated that she heard of this case through a pediatrician who was since retired. The patient was not a patient in the reporters office. She did not know if the patient had actually ever been a patient of the retired pediatrician. No further information was provided. No further information is available.
Shoulder pain, lack of range of motion. Hurt immediately after booster dose went away and now 4 days later is back and far worse.
SLIGHT FLU/UNDER THE WEATHER/TIRED/EXHAUSTED; CROAKY; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included: anaphylaxis reactions, and pneumonia, and concurrent conditions included: asthma, chronic obstructive pulmonary disease, immunocompromised immune system, bad allergies, and high blood pressure. The patient experienced drug allergy when treated with silicon dioxide for drug used for unknown indication. 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 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included diphenhydramine hydrochloride for anaphylaxis reactions. On 30-APR-2021, the patient experienced slight flu/under the weather/tired/exhausted, and croaky. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight flu/under the weather/tired/exhausted, and croaky on MAY-2021. This report was non-serious.
Moderna COVID-19 Vaccine EUA. Syncope with head trauma 15 hours after receiving vaccine.
Swollen injection site, injection site hot to the touch, painful for 6 days afterwards (and still hurts to touch it), serious fatigue for days after. Due date 2/16/19. Healthy pregnancy so far.
Patient was here for a nurse care for their second dose of Moderna bivalent vaccine. She was given 0.2ML from the pink cap Moderna vial. She should have received 0.25 ml from the blue cap Moderna vial. She will need one repeat dose of 0.25 ml from the blue cap vial Moderna vaccine to complete her series.
Mother reported and answered "yes" to question #7 to seizures. She said he had one at 5 mo of age and is not taking meds. Immunizations were given DTAP, Hep A, and ped influenza on 11-05-15. She says the next day she saw him having a seizure and took child to ER. Dr diagnosed immunization related seizure.
First dose of BNT162B2 on 22Jan2021 13:00 and Second dose of BNT162B2 on 08Mar2021 15:00; First dose of BNT162B2 on 22Jan2021 13:00 and Second dose of BNT162B2 on 08Mar2021 15:00; red rash all over her body; This is a spontaneous report from two contactable consumers (patient and patient's husband). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 08Mar2021 15:00 (lot number: EN6205) as single dose for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 22Jan2021 13:00 (lot number: EL9261) at single dose for COVID-19 immunization, and experienced red rash all over her body on 25Jan2021 09:00, had required visit to physician office, treatment with prednisone given, and was recovering. The patient experienced red rash all over her body on 08Mar2021 (reported at "09:00"), which required physician office visit, treatment received with Triamcinolone acetonide ointment. Red rash developed after 1st shot (also reported after 2 days) and after 2nd shot (also reported after 3 days) after vaccination. Doctors had her tab Prednisone. The rash had cleaned up, but 2nd shot caused reoccurrence. She is applying cream now. The outcome of the event red rash all over her body was recovering.  No follow-up attempts are possible. No further information expected.
My smell has been greatly effected since receiving the 1st dose of Moderna. I had COVID in December 2020. I lost taste and smell briefly for 6 days. It was my only symptom. But it fully returned to me after those 6 days. 3 months later I got my 1st COVID vaccine. The  morning after I got my moderna vaccine,  I lost smell again. And my sense of smell has been effected to this day after receiving the 1st vaccine.
Approximately two hours after receiving vaccine, the tip of my tongue went numb almost if I had eaten something bitter. The numbing sensation never progressed past the tip of my tongue but lasted up until I fell asleep. Next day, I was fine. Then Monday evening , I felt like I had a sty under my left eyelid. Tuesday morning, my daughter noticed my face was  drooping a little, on the left side by the afternoon my other daughter called me and picked up on it. Called Drs office and was told to report to  the Emergency Room .Arrived around 5:30 pm
Pt received Moderna booster and complains of swelling and itching around her entire upper arm. She has used hydrocortisone cream to help with the itching.
Patient was administered a prefilled Covid-19 vaccine injection in L deltoid. Patient was monitored for 15 minutes following vaccine administration. Post injection the clinic soon realized the injection was empty without the vaccine present. The "prefilled' vaccine was pulled back to 0.5 ml and individually packed and appeared to be a single use vaccine. The patient was called and notified via phone call of the situation and that the patient unintentionally did not receive COVID-19 immunization. Advised patient to FU for any questions or concerns. Health department was notified. Patient was understanding and denied acute concerns.
Here for 2nd Hep-B Vax. 1st Hep-B given here w/no problems mfg by SKB. Merck's Hep-B Vax recombivax HB, lot #0009J was used. After shot given, site became red & swollen. Within minutes had nodule formation. Vital signs were normal.
gave the Pentacel that included the extra IPV, No AE; Initial information received on 12-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare.  This case involves a 12 months old male patient who received vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ196ABA and expiry date 02-Mar-2021 via intramuscular route in the right thigh and fourth dose of IPV (VERO) [IPOL] lot U6615AA and expiry date 02-Mar-2021 via intramuscular route in the right thigh on 10-dec-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) Lot UJ196AB, Expiry Date 02-Mar-2021 for Immunisation; DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE) U6615AA, Expiry Date 02-Mar-2021 for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A) for Immunization.  It was a case of actual medication error due to extra dose administered. It was reported that an extra Polio Vaccine (fourth dose) was given since Pentacel that included the extra IPV was administered to the patient.   At the time of reporting, it was not reported if the patient had any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
have omicron; have omicron; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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), outcome "unknown" and all described as "have omicron". The patient reported that vacine omicron or pills for omicron, he/she had omicron.   The lot number for bnt162b2 was not provided and will be requested during follow up.
29JUL92 recvd 1st dose of Engerix-B & devel fever, dizziness, h/a, nausea & diarrhea as of 5AUG92;
PER NURSE PRACTIONER  INITIAL NOTES  Pt presenting to SD clinic c/o lesion/rash of the left forearm that appeared about 3 weeks ago. It appeared as 1 lesion few days after she got her 2nd dose of covid19 vaccine , and the lesion was getting larger, and she self drained the lesion and reports clear liquid drainage with no pain. Pt states the site has not improved and now few other spots has been visible and since this morning there is a round erythema surrounding the lesion.
This spontaneous report as received from a other health professional refers to a 36 year old patient. On 21-MAY-2014 the patient was vaccinated with M-M-R II lot # J006955. No other concomitant medications were reported. On 21-MAY-2014, 1 day after onset of therapy the patient experienced patients received m-m-r ii post not supported excursion (doses stored at 17c for 21.5 hours) and inappropriate schedule of vaccine administered. The outcome of patients received m-m-r ii post not supported excursion (doses stored at 17c for 21.5 hours) and inappropriate schedule of vaccine administered is unknown. The reporter stated that patients who received M-M-R II have not expressed any adverse events. The reporter considered patients received m-m-r ii post not supported excursion (doses stored at 17c for 21.5 hours), inappropriate schedule of vaccine administered and not expressed any adverse events to be not related to M-M-R II. This case is linked to same reporter linked cases # 1405USA004911 and # 1405USA012040. Additional information has been requested.
felt like the sensation that it was running through body; through legs, arms, chest/ mainly a sensation in legs, traveling from the top of legs down to feet/ No pain/ didn't last very long; This is spontaneous report from a non-contactable consumer (patient). A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on an unspecified date (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated he received the Pfizer COVID vaccine and had a side effect. Patient stated when he received his first dose, he felt like the sensation that it was running through his body; through his legs, his arms, his chest. There was mainly a sensation in his legs, traveling from the top of his legs down to his feet. No pain, it just felt like it was moving through his body and it didn't last very long. Patient asking if this is a common side effect. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient called on phone stating she was having an anaphylactic shock reaction. Was told by her primary doctor to contact us since she had received vaccine in the past couple of days and inform us we may have a bad batch. I have reached back out to patient to follow up, but have received no response, thus far.
Redness raised tender; Swelling; headache intermittent; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness raised tender), SWELLING (Swelling), HEADACHE (headache intermittent) and VACCINATION SITE PAIN (Pain at injection site) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Lyme disease.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ERYTHEMA (Redness raised tender), SWELLING (Swelling), HEADACHE (headache intermittent) and VACCINATION SITE PAIN (Pain at injection site). On 27-Jan-2021, ERYTHEMA (Redness raised tender), SWELLING (Swelling) and VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, HEADACHE (headache intermittent) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided