chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented with "crushing" substernal chest pain.  Initially with negative troponin and normal ECHO.  Admitted for observation.  Later in day had recurrence of chest pain, along with elevated troponin and EKG changes consistent with pericarditis.
Starting 04/17/2021, I was at home and sweating while playing video games. I had a headache, sinus issues (thought it was allergies) and I looked over at the diffuser I had bought and realized I couldn't smell it. I made coffee real quick and, upon drinking it, I couldn't taste it. So, I went to Urgent Care and they gave me a PCR test and told me to stay out of the public. On 04/18/2021, I took a rapid COVID test and it was negative. A day and a half later I tested positive. I was given antibiotics and took my BP medicine. I quarantined in my bedroom for about 7 days The loss of taste and smell lasted for about 7 days then went away.
0.5 ml of Zostavax was inadvertently administered to a 12 month old, when he should have had the varicella vaccine.
Noted reddened area of Lt deltoid after receiving FLUZONE and TDAP vaccines.
after vaccination, patient felt dizzy and lightheaded. after some bottled water and a cold compress, she did not feel better. we elevated her feet, and she still did not feel good, said she felt like she wanted to throw up. Emergency personnel came and took her to the hospital
PATIENT'S WIFE,  CALLED ON SATURDAY EVENING 5/8/21 @ 6:57PM. STARTED TO EXPERIENCE DIZZINESS AND NAUSEA AT HOME APPROXIMATELY 60-90 MINUTES AFTER VACCINE WAS ADMINISTERED,  THE DIZZINESS RESULTED IN A FALL WHICH PRODUCED A HEAD INJURY.  i ADVISED PATIENT TO CALL 911 IF SHE THOUGHT HE NEEDED IMMEDIATER AND EMERGENCY MEDICAL ATTENTION.  fOLLOW-UP CARE CALL ON SUNDAY MORNING 10:28AM, i SPOKE TO HIS WIFE AGAIN,  STATED HE WAS RECOVERING AND DID NOT REQUIRE EMERGENCY MEDICAL ATTENTION. i ADVISED HER TO OBTAIN HIS DOCTOR'S ADVICE AND CONSENT TO RECEIVE HIS SECOND PFIZER COVID-19 DOSE.
Dose administered more than 12 hours after initial puncture; Vial was punctured on 01-Sep-2021 at 11:05 AM/dose was administered on 02-Sep-2021 at 2:58 PM; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours after initial puncture) and PRODUCT STORAGE ERROR (Vial was punctured on 01-Sep-2021 at 11:05 AM/dose was administered on 02-Sep-2021 at 2:58 PM) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021 at 2:58 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021 at 11:05 AM, the patient experienced PRODUCT STORAGE ERROR (Vial was punctured on 01-Sep-2021 at 11:05 AM/dose was administered on 02-Sep-2021 at 2:58 PM). On 02-Sep-2021 at 2:58 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours after initial puncture). On 02-Sep-2021 at 2:58 PM, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours after initial puncture) and PRODUCT STORAGE ERROR (Vial was punctured on 01-Sep-2021 at 11:05 AM/dose was administered on 02-Sep-2021 at 2:58 PM) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment information was not provided.  The reporter stated that a pharmacy intern had administered an expired dose to the patient. The vial was initially stored in the fridge on 30-Aug-2021. It did not undergo any previous temperature excursion. The total amount of time spent at room temperature was 20 minutes.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Updated correspondence contact box, patient initials and gender. On 07-Sep-2021: Follow up contains no new information.
itching; swelling at the injection site, left arm; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site itching and injection site swelling. On an unknown date, the outcome of the injection site itching and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site itching and injection site swelling to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient experienced itching and swelling at the injection site, left arm. It had been now resolved. The patient had recently received her second Shingrix injection and did not experience any side effects. The reporter declined in providing her physician's contact information. The reporter did not consented to follow up.
Chills, fatigue, nausea, upset stomach, generally feeling unwell, no energy
22 children were inadvertently vaccinated w/1 dose of HIb & hep b instead of HIB same day had hep b vax;
Reported by charge nurse the above patient return because of increase swelling and redness to left thigh.  Area very warm to touch and patient complaining of pain when touched.  Having symptoms for 48 hours now.  Examined by doctor per appt.
This is a spontaneous report from a contactable consumer. A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown, expiry date: unknown), via intramuscular route of administration, administered in left arm on 05Mar2021 (at the age of 63-years-old) as dose 1, single and again received of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown, expiry date: unknown) via intramuscular route of administration, administered in left arm on 26Mar2021 (at the age of 63-years-old) as dose 2, single for COVID-19 immunisation. Patients medical history included HIV positive and high blood pressure. The patient had unknown allergies. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received medications within 2 weeks of vaccination, but not sure which medications. Since the vaccination, the patient was tested for COVID-19. It was reported that the patient was tested positive for COVID-19 on 24Jul2021, following exposure on 14Jul2021 to others who also tested positive. Fortunately, symptoms were mild slight shortness of breath, mild fever, and congestion on 18Jul2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received antibody treatment, oral steroids antibiotics, an inhaler for the events. There was no hospitalization required for the events. The patient underwent lab test which included SARS-CoV-2 test: Positive Nasal Swab on 24Jul2021. The outcome of the events was recovering.
January sympotoms congestion, fatigu and coughing lasted for 2 weeks towards end of January symptoms returned 02/20/2023 went to see doctor, received checked vitals all normal.  03/10/2023 symptoms subsided.
No further adverse events; administration of expired dose of VAQTA; This spontaneous report was received from  a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 01-APR-2022, the patient started therapy with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 dosage form, lot #T017179, expiration date reported as 15-OCT-2021, but upon internal validation was confirmed as  26-OCT-2021, administered for prophylaxis (strength, and route of administration were not provided). No adverse events were reported.
This spontaneous case, initially received on 07-Feb-2017, was reported by a non health professional and concerns a(n) female patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN) for Indication not reported. Dose regimen: Not reported, Route of administration: Not Reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date after receiving the injection, the patient experienced a headache. The outcome was not reported.
Right after the vaccination arm was in pain which was out of norm--could not even put coat on.  Later that night had chills, headache and flu-like symptoms started and lasted for 3 days total.  Two days after vaccine developed canker sore and was very painful. The sore was on the outside not on the inside so it felt like a cut in the middle of the lip. Patient waited 2 days before calling doctor and prescribed Valacyclovir-HCL.  Medication helped with cold sore.  2-3 days after vaccine, numbness started going up and down arm of vaccination. Symptoms eventually resolved.    Today back to normal. Contacted the pharmacy to explain symptoms; they did not provide any recommendations just specified some of the symptoms were typical and some were not.  Patient received 2nd dose of vaccine on 2/4/2020.  The symptoms were not as severe and only had pain and flu-like symptoms.  Symptoms also lasted about 24 hours.
1435, pt received 1st dose of covid vaccine (Pfizer) while sitting in a chair in covid vaccine clinic. NKDA. No known history of seizure per pt's mother. Mother with pt, stated pt started feeling unwell, pale, then losing consciousness. Patient's mother stating patient's eyes started to roll back. 1436, pt had seizure activity, staff lowered pt on the floor, laying on side, no n/v noted, lasted for 25 seconds. VS taken, Oxygen applied. Initial BP 77/26, 100% with 2 L NC oxygen. BP improved to 139/81, HR 74, 100% 2 L NC oxygen after sitting. Pt regained his consciousness, aao x4.  1445, 911 placed. BP 127/64, HR 66, 100% with 2 L NC Oxygen 1500, EMT arrived and transported pt to ER, accompanied by pt's mother
09/08/22 presents to ED for "urinary catheter problem, blood pressure". PMHx of "stroke with residual hemiparesis, suprapubic catheter"
Patient complained of feeling faint and them numbness in her limbs.  Patient then started complaining of not being able to breathe and heaviness in her chest.  The patient started having symptoms about 25 minutes after receiving vaccine.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies. On unknown dates from 01-FEB-2017 to 18-APR-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot#: M041213, expiry date: 22-JUN-2018 (dose and route of administration not provided) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 8 hours 10 minutes. Data logger was not used to capture temperature excursions. There were no previous excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA003082: US-009507513-1705USA003083: US-009507513-1705USA003081.
stiffness; body aches/"slight twinges" (not pain) in lower body (feet, ankles and shins); needle pain after the injection; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness), VACCINATION SITE PAIN (needle pain after the injection) and MYALGIA (body aches/"slight twinges" (not pain) in lower body (feet, ankles and shins)) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     Concomitant products included FISH OIL (OMEGA 3 [FISH OIL]) for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced VACCINATION SITE PAIN (needle pain after the injection). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness) and MYALGIA (body aches/"slight twinges" (not pain) in lower body (feet, ankles and shins)). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness), VACCINATION SITE PAIN (needle pain after the injection) and MYALGIA (body aches/"slight twinges" (not pain) in lower body (feet, ankles and shins)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included multivitamin.   This case was linked to MOD-2021-236083 (Patient Link).
About 5 minutes after, I felt light headed at first and when I looked at light it looked blotchy and blurry the next day (and had tunnel vision). I had flushing going on and started getting facial pain (Saturday). My arm was sore but that stopped a few days. Facial pain in my sinuses on third day. 4th day, doctor visit and I was extremely dizzy and I had very full feeling (like they were filled up with fluid) in my ears. I noticed that I had a heavy high pitched ringing in my ears constantly. The lightheadedness and fullness in my ears. Pain in my forehead and temples and constant earaches. My hearing feels like my ears are very plugged. It all comes and goes in spells. For instance, if I get up super fast on third day, when I stood up, I would get dizziness, earaches and facial pain. I am still experiencing these things occurring. Facial pain has gotten a little better it's happening less. I do still have pain, ringing and fullness in ears still. I will probably be seeing an immunologist or allergist to see if I'm having allergies to anything in the vaccine.
permanent brain injury; This case was reported by a consumer via interactive digital media and described the occurrence of brain injury in a male patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced brain injury (serious criteria GSK medically significant). On an unknown date, the outcome of the brain injury was unknown.   It was unknown if the reporter considered the brain injury to be related to DTPa vaccine.  Additional details were provided as follows: The patient's parent reported the case. The age at vaccination was not reported. The reporter was frustrated and stated that, it was better to have few weeks of coughing to the patient than the lifetime suffering due to permanent brain injury.
feel bloated; my throat didnt feel right; cant eat much; face is a little swollen; Its getting hard to swallow; This case was reported by a consumer and described the occurrence of bloated feeling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2019, the patient received the 1st dose of Shingrix. On 18th August 2019, 5 days after receiving Shingrix, the patient experienced bloated feeling, throat discomfort, unable to eat, facial swelling and swallowing difficult. On an unknown date, the outcome of the bloated feeling, throat discomfort, unable to eat, facial swelling and swallowing difficult were unknown.   It was unknown if the reporter considered the bloated feeling, throat discomfort, unable to eat, facial swelling and swallowing difficult to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On or about the 18th August 2019, the patient noticed that her throat did not feel right. It's getting hard to swallow. Overall, she felt bloated, and could not eat much. The patient face was a little swollen, but no one else would notice. The patient noticed it because of her facial lines were not as noticeable. The patient stated that she read the information that states that reactions usually occur within a few hours after receiving the vaccine. The patient asked if it possible that she getting a delayed reaction to it.
The day I got the vaccine I felt nothing at the injection site and I felt absolutely fine.  But  at about 9:00 PM on  3/17/2021, I immediately started feeling very ill.  I was freezing cold and it felt like ice was flowing through my veins; my breathing became much more rapid and deep (no congestion) and I felt weak and achy.  Then my teeth started to chatter.  I took 1 Aleve , which did nothing (after 90 minutes) and then took 2 packets of Emergen-C Immune system defense (an OTC vitamin supplement) in a small glass of water. I started to warm up and feel much better at about 1:00 AM.  At this time I took my temp which was 100 degrees.  I have felt fine since this strange episode, except I still  feel a little bit fatigued.
Mom phoned on 1/18/2007 and reported that on 1/12/2007 client's feet and hands turned bright red after receiving Hepatitis A -2nd dose.  No other symptoms.  Did not have breathing difficulties, high fevers, etc.  Just reddened hands and feet.  Client was given Benadryl and syptoms resolved with no sequelae.
Patient with 2 Pfizer COVID vaccinations, last dose 02/18/21, who admitted to hospital and had an incidental positive COVID test upon admission.  Provider discharge note below:  "84 YO male who presented with gross hematuria and constipation. Labs notable for hyponatremia, UA with gross hematuria and CT imaging noting ileus with extensive stool burden and chronic abdominal hernia with ascending colon. COVID test positive as well.    During his hospitalization stay, he received aggressive bowel regimen which resolved his ileus and constipation. Urology has evaluated patient who recommend outpatient cystoscopy. Nephrology was consulted and deemed etiology of his hyponatremia was from tap water enema and from heart failure. Patient was started on Lasix PO in addition to daily salt tabs with fluid restriction. Tap water enema was discontinued. Hospice was consulted as well due to patient and wife's concern for patient's debility and wishes for no further inpatient stay in the future. After speaking with Hospice liaison, patient and wife elected not to sign up for Hospice yet but will contact Hospice team if needed."
This spontaneous report was received from a healthcare worker and refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 15-NOV-2016, the patient was inadvertently vaccinated with a 0.5 ml dose of expired PNEUMOVAX 23 intramuscularly (frequency reported as "once", lot # L022795 with expiration date at 05-NOV-2016) for prophylaxis. There were no adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Fever began 6 days after vaccine administration; rash began 6 days after vaccine  administration; Rash is a macular, erythematous blanching rash on both lower and upper extremities, trunk, diaper area, and outer ears
27OCT92 4PM fever 103 cont elevation during noc; 4PM crying cont all noc & most of the next day & irritable; 5PM shaking & jerking last PM & today 28OCT92; last PM vomited x 4; diarrhea today x 3 watery; phoned MD last PM;
Received 2nd GARDASIL injection 10/26/2009. After injection reported headache & dizziness. Examined & observed by Dr. Given Tylenol & went home in stable condition.
PT RECEIVED A FIRST DOSE OF THE MODERNA VACCINE IN THE LATE MORNING OF 04/17/2021. PT'S DAUGHTER CALLED ON THE MORNING OF 04/19/2021 AND SAID SHE WAS CONCERNED ABOUT HER DAD AS HE HAD BEEN COMPLAINING OF A "VERY BAD FEVER, HEADACHE AND CHEST PAIN." PT'S DAUGHTER WAS ASKED IF HER DAD HAD TROUBLE BREATHING AND SHE SAID YES. WHEN ASKED ABOUT HOW LONG IT HAD BEEN GOING ON, SHE SAID SINCE LAST NIGHT. SHE ALSO SAID THE FEVER HAD REACHED 102 DEGREES. PT'S DAUGHTER SAID HER DAD HAD NOT TRIED TAKING ANYTHING TO HELP TREAT THE FEVER OR HEADACHE. SHE ASKED ABOUT IF SHE SHOULD HAVE HIM TAKE TYLENOL, BUT DUE TO THE COMPLAINT OF "SEVERE CHEST PAIN" AND "DIFFICULTY BREATHING," IT WAS RECOMMENDED THE PT SEEK IMMEDIATE MEDICAL ATTENTION AND GO TO THE ER. PT'S DAUGHTER CONFIRMED THAT SHE WOULD.
WBC came back 20K with ANC 16K; WBC came back 20K with ANC 16K; This case was reported by a other health professional via call center representative and described the occurrence of white blood cell increased in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included asplenia.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced white blood cell increased and absolute neutrophil count increased. On an unknown date, the outcome of the white blood cell increased was recovered/resolved and the outcome of the absolute neutrophil count increased was unknown.   It was unknown if the reporter considered the white blood cell increased and absolute neutrophil count increased to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The asplenic patient received dose of Bexsero and went for routine blood draw for other reasons.  The patient was not sick before and after immunization. The white blood count came back 20 K and absolute neutrophill count was 16 K. The Subsequent CBC a few weeks later was normal. The reporter asked if, was this just a benign demargination phenomenon or leukemoid reaction. No additional information was provided. The reporter consented to follow up.
she compared it to a really bad allergy shot.; The patient also reported that on Friday 10/9/2020 she received Shingrix and that it hurt and her arm was "sore yesterday as a result of the vaccination; The patient reported to the caller that about 10 years ago, when she was 60 or 61 years old, she received ZOSTAVAX and a year later she came down with shingles.; This spontaneous report was received from a consumer via a company representative, referring to herself as a 72-year-old female patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   In approximately 2010, when the patient was 60 or 61-year-old, she was vaccinated with zoster vaccine live (ZOSTAVAX), as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not reported).  In approximately 2011, a year later after the vaccination, she came down with shingles (herpes zoster).  On 09-OCT-2020, it was administered to the patient zoster rge vaccine (mammalian) (SHINGRIX) (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, indication, lot number and expiration date were not reported).  At the time of this report, the patient stated that; it hurt and her arm was "sore yesterday as a result of the vaccination, she compared it to a really bad allergy shot" (pain in extremity and allergy to vaccine).  The outcome of herpes zoster was reported as recovered; at the time of this report the outcome of pain in extremity and allergy to vaccine was not provided. The causality assessment between zoster vaccine live (ZOSTAVAX) and zoster rge vaccine (mammalian) (SHINGRIX) with the aforementioned events was not provided.