chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 06-Sep-22.; No adverse event; The patient received dose after 30 day use date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 06-Sep-22.) and NO ADVERSE EVENT (No adverse event) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Sep-2022 at 12:19 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2022 at 12:19 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 06-Sep-22.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 06-Sep-22.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 06-Sep-22.).    No concomitant medications was reported.  On 18-Apr-2022 the vial was delivered and stored in the refrigerator on same date. The vial size is of 5.5mL. The vial did not undergo any temperature excursions. Vaccines were only offered on Tuesdays from March-2022 forward to the patient. For each Tuesday vaccine date, only removed one vial from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator).  No treatment drug details was reported.
10 days post immunization of varicella, pt complained of low grade fever, approx 30 vesicular bumps appeared on trunk.
Fever, chills, achiness, dizziness, vomiting, nausea, headache
Pfizer second shot, non stop menstrual bleeding since August, IUD and birth control will not stop it. Tested negative for autoimmune, Ovarian blood cysts are new.
Left arm red, swollen, and sore/painful from elbow up to injection site. Self treated with Tylenol and ice packs. Doctor treated with Keflex for 10 days and Allegra for 10 days.
I got sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I got sick".  Additional information: When the patient got the COVID shots there was Moderna, there was Johnson and Johnson and the Pfizer shot. He happened to take the Pfizer shot because that was what his doctors told him to take. For a day or two he got sick but he did not pick up the phone and call Pfizer and say shot made him sick.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
This spontaneous report as received from a consumer via Clinic refers to a currently 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-NOV-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # L049314, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
eosinophilia esophagitis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced eosinophilia esophagitis on an unspecified date with outcome of unknown after full course of COVID vaccine and nothing else in her life changed.  No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.
Patient received 3 doses of Shingrix.  Dates 5/27/2021 , 8/24/2018 , 6/4/2018
This spontaneous report was received from a pharmacist, referring to patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 19-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot # L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects effect reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports from the same source (original report 1602USA004808). Additional information has been requested.
Patient seemed fine immediately after the vaccine and walked to a nearby chair to wait for 15 minutes for observation. I was alerted by the pharmacy technician I was needed outside of the immunization room and patient had vomited. It seemed to be mostly stomach acid (no food particles) and was roughly 12oz or less of fluid (hard to tell since it was contained in a plastic bag. Patient sipped on some water, which she tolerated well. She stated she suddenly felt really dizzy and then felt the need to throw up. After the water, she felt better and was looking to see if eating something would help settle her stomach. She did not appear pale or diaphoretic. I encouraged her to stay longer for continued observation by she left before 15 minutes were up after the vomiting. She was in the pharmacy observation area for about 20 minutes total. She smiled and waved as she left.
This spontaneous report was received from a physician referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients' were vaccinated with improperly stored doses of ROTATEQ oral lot # K013868 expiration date 27-MAY-2016 (strength and dose were not provided). The patients' concomitant medications were not provided. The physician stated, he needs to check his records to see if any were administered, but he "believed some were administered". The physician reported the following temperature excursion for the administered vaccines: 30.2 F for 4 hours, 31.1 F for 10 hours, 34.5 F for 10 hour and 34.6 F for 10 hours (cumulative time out of range was 34 hours). No previous temperature excursion was reported. At the time of the report, no adverse effects were reported and no product quality issue was involved. Additional information has been requested. This is one of two reports received from the same reporter.
Sedation, Myalgia, Arthralgia, Phlebitis & Fever
Extremely sore and red left arm. Fever for 5 days. Inflammation of the entire abdomen and increase in abdominal size of 2 inches. Hot flashes that are every hour. Insomnia
A non-serious spontaneous report of positive for flu with symptom of fever has been received from a non healthcare professional/company representative concerning a five-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. In Nov-2009, the patient received H1N1, Intranasal for an unknown indication. In Nov-2009, after receiving H1N1 vaccine, the patient got sick. Six days later she tested positive for flu. The patient had only fever at the time of reporting. The dose was administered at a clinic. The outcome of this event was not recovered.
During an in-store Flu clinic, I inadvertently gave Flublok vaccine to a patient that wasn't age-appropriate. I notify the patient's patients concerning the error. The parents had some questions about the possible side effects of the vaccine.  They said that their child was doing well. There seem to be no negative effects from the vaccine.
Started having symptoms starting late on the night of the vaccination. Prominent headache, aches all over body, and exhaustion. Low-grade fever noted the following morning of 100.3.   Tylenol taken to alleviate all symptoms
Shingles; Really fatigued; Took a nap; Had a low grade fever; Getting a little rash to her left butt cheek and it got worse and was spreading and oozing; Oozing; Burning; Itching; Her 2nd dose is when this began and states she had soreness in her arm; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in Arm Left on 28Apr2021 14:00 (Batch/Lot Number: EW0170) as 2ND DOSE, SINGLE for covid-19 immunization.  Patient had received her 1st dose of bnt162b2 vaccine (Batch/lot number: EW0158   administered left arm ) on 07Apr2021. Patients' Medical history was not known. Concomitant medications include multivitamins. The patient was not hospitalized, no Prior vaccinations were taken within 4 weeks, no AE prior to vaccinations, no Relevant tests were done. After 1st dose patient experienced sore arm. After her second dose patient experienced shingles- herpes zoster, fatigue, took a nap- somnolence, low grade fever- pyrexia, a little rash to her left butt cheek and it got worse and was spreading and oozing- skin weeping, burning sensation, itching- pruritus, soreness in her arm- pain in extremity. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit. Patient took Tylenol for fever, antiviral medication for shingles, ointments like Neosporin (expiry date is Jul2022 and lot is 2210 LZ/1 imprinted on the bottle and the box has lot 2210LZ with UPC number 0081074688, and is dual action strength ointment and pain relief), Hydrocortisone 1% and is Cortisone 10 (expiry date Oct2023, lot 20L109 and UPC on the box of 4116703396) and it is water resistant itch relief. The outcome of events was unknown.    Follow-up (17May2021): This is a follow up spontaneous report received from a contactable consumer.  No new information was recorded. Information on Lot/Batch number was available. Additional information has been requested.
I started to get hives on my neck, it spread to my back it itched really bad. It looked like somebody whipped me. Then it proceeded to spread to everywhere on my body and the only place I didn't seem to get it was the bottom of my feet. I was icing it but my doctor told me to stop because it was making it worse. The first doctor I saw I prescribed me with a 5-day steroid regimen that didn't work. It continued for two weeks then my doctor told me to take Benadryl and that helped. It was very intense but then slowly subsided. Now it only comes back every once in a while but when I drink wine or after I shower it intensifies in size and in more areas.
PAIN, SWELLING IN RIGHT ARMPIT, SWOLLEN LYMPH NODES.  DR SAID TO MONITOR AND CALL BACK IF IT DOES NOT GO AWAY IN A FEW WEEKS
Fatigue; Low grade fever; Weakness; Poor sleep; This is a spontaneous report from a contactable consumer. An 89-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 25Sep2021 (at the age of 89-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Sep2021, the patient experienced fatigue, low grade fever, weakness and poor sleep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, low grade fever, weakness and poor sleep was resolved on an unknown date in Sep2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Per patient she states she was having difficulty swallowing and was feeling dizzy after receiving the Covid vaccine,  RN states there was no swelling of the tongue and/or mouth,  Vital signs within normal limits at this time.
Extensive, painful swelling and redness radiating from injection site. Multiple bumps below injection site.
Runny nose 3 months after first booster; Stuffy nose 3 months after first booster; Sore Throat 3 months after first booster; Mild Temperature 3 months after first booster; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHOEA (Runny nose 3 months after first booster), NASAL CONGESTION (Stuffy nose 3 months after first booster), OROPHARYNGEAL PAIN (Sore Throat 3 months after first booster) and PYREXIA (Mild Temperature 3 months after first booster) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced RHINORRHOEA (Runny nose 3 months after first booster), NASAL CONGESTION (Stuffy nose 3 months after first booster), OROPHARYNGEAL PAIN (Sore Throat 3 months after first booster) and PYREXIA (Mild Temperature 3 months after first booster). At the time of the report, RHINORRHOEA (Runny nose 3 months after first booster), NASAL CONGESTION (Stuffy nose 3 months after first booster), OROPHARYNGEAL PAIN (Sore Throat 3 months after first booster) and PYREXIA (Mild Temperature 3 months after first booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Body temperature: Mild Temperature 3 months after first booster. On an unknown date, SARS-CoV-2 test: (Negative) Negative.         Concomitant product use was not provided by the reporter.  The patient received first booster dose of Moderna COVID-19 vaccine three months prior to the date of this report on 23-Apr-2022. She had runny nose, stuffy nose, sore throat, and mild temperature.   As per her pharmacist, she was due for the second booster dose.   Treatment information was not provided.
Patient seen by employee health on 10/21/10 complaining of erythema, warmth, and swelling at injection site. Was seen by a primary care provider.
Information has been received from a nurse concerning a 19 year old female with an allergic reaction to septra (hives) and a history of passing out with injections who on 08-JUN-2007 was vaccinated with Gardasil (lot# 657736/0389U). On 08-JUN-2007 the patient passed out. Medical attention was sought. The patient stayed in the office for about half hour and during that time the patient was laying down. The patient's vitals were  rechecked and patient was okay and sent home. No product quality complaint was involved. Additional information has been requested. In follow up the physician reported that "there have been no problems with any of our patients". No further information was available.
Next AM after injection woke up with swollen red arm and pruritis. Was given Rx for antibiotic.
Vaccine administered beyond use date; Vaccine administered beyond use date; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 22-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Jan2023 as dose number unknown (booster), single (Lot number: GH9703) at the age of 22 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 03Jan2023, outcome "unknown" and all described as "Vaccine administered beyond use date".  Additional Information: The vaccine beyond use date was 30Nov2022 and the vaccine was administered on 03Jan2023. The vaccine was kept stored in the refrigerator within range and in a sealed vial. The caller requests stability information. Callback attempt on 11Jan2023 at 12:16 PM: Successful. Caller on the line reporting that a 22-year-old female received the grey cap covid-19 bivalent vaccine past the beyond use date. Beyond use date was 30Nov2022 and vaccine was administered on 03Jan2023. Vaccine had been stored in the refrigerator and in sealed vials. Product storage error. Based off the delivery date, the vaccines were delivered on 21Sep2022 and put into a fridge. The vaccines are only good for 10 weeks once refrigerated.   No follow-up attempts are possible. No further information is expected.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No Treatment medications were provided
Chills for several hours.  Mild headache and fatigue lasting approx sixteen hours.
Initially I only had a sore arm, but by evening started to feel mentally foggy. During the night, I did not have a fever, but experienced chills. On the second day, I continued to feel mentally foggy, and was unable to work. I wasn't nauseated, but felt like I was at the tail end of the flu -- achy, tired, occasional chills, etc. On the third day, I awoke with a low-grade fever (99 degrees), and was very tired. I lay down briefly, and slept six hours without waking up. Most of my symptoms were gone when I awoke, but the brain fog is still with me on the morning of Day 4. I'm still not comfortable driving or making important decisions.
Patient is a 78 Y male with a history of pre-diabetes; aortic atherosclerosis; congenital absence of testicle; tension headache; psoriasis; exploratory surgery 1970 to find testicle (never found the testicle); excision arm and leg melanomas.   Patient presented 2/16/2023 with acute onset of upper abdominal pain that started this AM.  Labs with leukocytosis (WBC 18.7), abnormal LFTs (elevated AST, ALT, bilirubin; however alk phos normal).  Ultrasound with gallstones, only minimal GB wall thickening, only mild CBD dilation 9.8 mm.   Suspect cholangitis.  Imaging and exam do not support cholecystitis.  Potentially may have passed a stone already as he is pain free (received 4 mg IV morphine at 4:45 PM).
At first it was just a common ache in arm at the injection site, but then I was unable to raise my arm higher than 180 degrees without pain. After 2 weeks, I mentioned it to the pharmacy. They said they had not had that complaint. After a month, I reported it to Novartis Pharmaceuticals. They said that they had had reports of similar pain from others. Unfortunately, it's over 3 months now, and I continue to have the same pain, I can't lift anything too high with that arm without pain. I can't sleep on that shoulder without pain. I was hoping the pain would abate, but it has not.
H-406-005: A Phase IV Enhanced Safety Surveillance Study of ACAM2000.  Subject #: 5000102.  This study case was received from the investigator in the above mentioned trial on 29 March 2011.  A 22 year-old male subject with no significant medical history was found to have non-specific myocarditis 20 days after he received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer name, lot number, route and site of administration not reported) on 07 August 2010.  Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 04.76, an abnormal electrocardiogram (ECG), and a normal Echocardiogram.  Lumbar puncture and MRI of brain, spinal cord, and heart were not performed.  Treatments were not reported.  The subject's outcome was not reported.  Additional information will be requested from the investigator.  Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.  Documents held by sender: none.
48-year-old patient who need to receive GARDASIL 9; No other AE; Spontaneous information has been received from a consumer regarding a 48-year-old female patient who needed to receive HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). The patient was on unspecified immunosuppressants due to a lung transplant and a "leep procedure". It was confirmed that at the time of reporting, the patient had not received a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). No other adverse event was reported.
1  week and 1 day after the 2nd dose of the vaccine (5/14/2021) , I went to see my dentist and got my blood pressure taken and it was high 167/103.  I had no symptoms except a typical bruising around the injection site.  I purchased a blood pressure monitor and decided to take home readings.  All my readings were high and I scheduled a doctor's appointment.  I went to the doctor on 6/4/2021 and my blood pressure was still high. Blood and urine samples were taken and everything came back normal.  I was put on a blood pressure medication Losartan 25mg once a day.  My pressure is coming down but still not in normal range.  I have an Echocardiogram schedule next month for July.
I had my vaccination on 10/03/2022. On 11/03/2022 I started having heart palpitations and kept getting worse. I went to the emergency room on 12/02/2022. 12/02/2022 Blood panel, Thyroid, EKG. All normal except EKG which showed PVCs. 12/03/2022 Heart monitor showed a fibrillation. I saw a cardiologist on 12/15/2022. The doctor prescribed metoprolol and flecainide. I have a follow up appointment with cardiologist in 02/2023.