chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received his second dose of Pfizer. During observation the patient did have a near syncopal episode as he was attempting to exit his car, began to walk towards the patient and saw him lean against the car and helped the patient to the ground, EMS was called. Vitals were taken as follows:  13:08- 110/70 HR 98 RR 16 O2 96  13:13- 118/80 HR 74 RR 18 O2 94  EMS arrived at 13:18 and vitals were taken and are as follows:  128/66 HR 80 RR 18 O2 98 BGL 92  124/90 HR 76 RR 18 O2 93  Patient was provided with juice and crackers, and was observed for an extensive period of time with EMS. Patient declined transport to the hospital via EMS as he was alert and oriented x 3. Patient was advised to contact his PCP but he declined having one. RN instructed the patient to contact 911 if there is shortness of breath, difficulty breathing, and any other sign of distress.
Felt like was going to pass out; Diarrhea; Vomited; This is a spontaneous report from a contactable consumer report for self. A female patient of an unspecified age received first doe of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Apr2021 3:00PM as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had the first dose of the covid vaccine on 13Apr2021 around 3:00PM. The next day, 14Apr2021 around 3:00PM, she started to have symptoms. She had diarrhea, vomited, and felt like she was going to pass out. She was supposed to get her second dose of the covid vaccine on 04May2021 (second dose of the covid vaccine is scheduled on 04May2021). She was wondering if she will have the same reaction for the second dose. The outcome of events was unknown.
pneumonia encephalitis devel w/in 3 days, hospitalized for 8 days; pneumonia treated w/anti viral & anti bacterial drugs;
a female patient received expired Menactra vaccine; Initial information received on 11-Jul-2019 and additional information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an 18-year-old female patient who received a 0.5 ml dose of expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] vaccine lot U5917AA via unknown route in the right deltoid on 10-Jul-2019. It was 2 of 2 in series.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) in left deltoid.  It was an actual medication error due to expired vaccine used.  Adverse event was not reported.  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.  List of documents held by sender: none.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with an improperly stored doses of ROTATEQ (oral suspension, dose, frequency, lot# and expiration date were not reported). No adverse effects were reported. Product quality issue (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse symptoms were reported; the patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a nurse regarding a patient of unknown age, gender and race.  The patient's concurrent conditions, pertinent medical history and drug reactions / allergies were not reported.   On 30-MAR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot number S024366, expiration date 06-AUG-2021, for prophylaxis (dose and route of administration were not reported). A properly stored sterile diluent (lot number R019504, expiration date 04-NOV-2020) was used to reconstitute varicella virus vaccine live (oka/merck) (VARIVAX).  There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -14 (°C) degrees Celsius to -10 °C (-12.2°C) for 4 days, 11 hours and 40 minutes. Data logger was involved. There were no previous excursions reported.
Sore upper arm, to be expected/ arm feels weak and hurts while using.; Injection site still extremely sore; arm feels weak and hurts while using.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 26Mar2021 at 15:00 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known drug allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included unspecified regularly prescribed medications. On 26Mar2021 at 15:00, the patient experienced sore upper arm, which patient had expected. However, injection site was still extremely sore, arm felt weak and hurt while using. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore upper arm injection site was still extremely sore, arm felt weak and hurt while using was not resolved at the time of report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 16Apr2021 at 15:00 (at the age of 41-year-old), as a single dose for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Started having symptoms of fever and bodywide muscle aches.  Fever reached  102 F.  Sought care at medical clinic.
Local tenderness as moderate starting 1 hr after vaccine given.  At 24 hrs post-vaccination an enlarged, tender supraclavicular lymph node was palpable on the ipsilateral side.  No other nodes present at 48 hrs.  Mild myalgias, Afebrile at 48 hrs.  Patient is physician reporting- lot number can be verified at a later time.
patient reported generalized weakness and fall at home which started shortly after receiving vaccine.  progressed to the point of severe weakness causing him to fall and not be able to pick himself up from ground.  reports that around 2 AM on Friday, 3/5 patient had gotten up to go to the bathroom, he felt very weak, was unable to successfully ambulate to and from the bathroom and had a fall without injury on his way back to the bed.  His wife was able to assist him back into bed and he rested later in the morning he got up a second time to go to the bathroom he essentially crawled to the bathroom.  he was unable to get back to bed his wife was able to help him to sofa in the living room which was nearby; states that he basically leaned against the sofa until this morning when family arrived and helped bring him to the hospital for evaluation.  Patient denies shortness of breath but the patient is breathing approximately 34 times a minute on my physical examination.  He denies pain.  He has had no nausea or vomiting since his vaccination.
patient c/o lips tingling, itching and swelling which started evening after receiving vaccine./ evaluated by provider in office on 6/22/23 and given RX for Prednisone 40mg daily x 7 days. Provider does not think symptoms are related to vaccine but report filled out just to be safe.
Pt seen in Triage presented with bilateral leg of warm, tender to the touch and itch. Area on the rt leg circumference was about 3 1/2 inches, the lt leg circumference was about 2 inches. Father was instructed to use warm compresses bilteral legs. If presented with high fever and or SOB to take to ER. If presented with fever and not feeling better call us on Monday to be seen. Dr. evaluated the triage note and said that the reaction paper that the family was given stated that the paper said that areas can swell. We did give him the paper that states the reaction to immunizations.
Acute MI requiring emergent placement of stent, complicated by LV failure Discharged from hospital to home care and followup cardiac rehabilitation
Pain, redness, swelling, burning, throbing pinching mucle pain, tired, weak Headache, diarrhea, throwing up, fainted lost 8 lbs, still cannot eat slight concussion when I fainted Black eye from fainting. This cost me $163.09 to be so very sick.
A Moderna Covid-19 Vaccine vial that hit 30 days of refrigerated storage on 3Jan2022, and 2 doses were given from that vial on 6Jan2022; A Moderna Covid-19 Vaccine vial that hit 30 days of refrigerated storage on 3Jan2022, and 2 doses were given from that vial on 6Jan2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A Moderna Covid-19 Vaccine vial that hit 30 days of refrigerated storage on 3Jan2022, and 2 doses were given from that vial on 6Jan2022) and PRODUCT STORAGE ERROR (A Moderna Covid-19 Vaccine vial that hit 30 days of refrigerated storage on 3Jan2022, and 2 doses were given from that vial on 6Jan2022) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A Moderna Covid-19 Vaccine vial that hit 30 days of refrigerated storage on 3Jan2022, and 2 doses were given from that vial on 6Jan2022) and PRODUCT STORAGE ERROR (A Moderna Covid-19 Vaccine vial that hit 30 days of refrigerated storage on 3Jan2022, and 2 doses were given from that vial on 6Jan2022). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (A Moderna Covid-19 Vaccine vial that hit 30 days of refrigerated storage on 3Jan2022, and 2 doses were given from that vial on 6Jan2022) and PRODUCT STORAGE ERROR (A Moderna Covid-19 Vaccine vial that hit 30 days of refrigerated storage on 3Jan2022, and 2 doses were given from that vial on 6Jan2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  Date the vial was first stored in the refrigerator on 04 Dec 2021. Vaccine vial hit 30 days of refrigerated storage on 03 Jan 2022.  Nurse reported that two patients received expired vaccine for their booster shots, past 30 days use by date.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jan-2022: Significant Follow up received. Patient information ( Initials, Gender, Date of birth) was updated. Suspect product dose number was added. Batch/lot number was added.
Following both dose #2 and #3, experienced episodes of vertigo. Have never had vertigo previously. Occurred 2.5 weeks after second dose (second dose on 4/24/21) for approx 48 hours. Unable to work (work at home on computer), walk, drive.  Received 3rd dose on 10/26/21. In early morning hours of 11/1,  vertigo began (currently ongoing). Only commonality can find between two episodes is that both occurred not long after a vaccine dose. However did not have any dizziness/syncope/vertigo after first dose in March.
Fever, vomiting, and abdominal pain started 9/28/11, then on 9/29/11 woke up very disoriented and delusional (no fever at that time) plus c/o back pain. Was taken to ED and received IV fluids with some resolution of symptoms.  No further vomiting/abdominal pain on day of ED visit.
Overheated; Muscles hurt; Chills; Felt fatigued; Feverish; This spontaneous case was reported by a nurse and describes the occurrence of BODY TEMPERATURE INCREASED (Overheated), MYALGIA (Muscles hurt), CHILLS (Chills), FATIGUE (Felt fatigued) and PYREXIA (Feverish) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced MYALGIA (Muscles hurt), CHILLS (Chills), FATIGUE (Felt fatigued) and PYREXIA (Feverish). On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (Overheated). At the time of the report, BODY TEMPERATURE INCREASED (Overheated), MYALGIA (Muscles hurt), CHILLS (Chills), FATIGUE (Felt fatigued) and PYREXIA (Feverish) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: increased (High) patient temperature got high after working in 103 degrees Fahrenheit temperature in the woods and stated that he was fine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter.    This case was linked to MOD-2021-286538 (Patient Link).
Physical hyperactivity, verbal hyperactivity (began talking and making noises almost constantly), increased agitation
5/14/03 4pm imm given. 5/15/03 5pm upper arm swelling and redness reported by parent. Generic Tylenol given. 5/16/03 am to LMD. Tx with Zyrtec 1mg 1/2t. bid x 3 days.
Pain & swelling of lt arm; Seen 2d later on 13MAR entire lower half of lt upper arm was swollen; red, hot, indurated & painful, pt unable to bend lt elbow;
Swollen lump on right arm. Elevated temp 101. Teething at the time.
aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches) and HEADACHE (headache) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aches) and HEADACHE (headache). At the time of the report, PAIN (aches) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
On 6FEB92 pt was extremely irritable; taken to ER where dx poss ear infect; pt given ? meds; on 7FEB92 pts fever to 105 R while on APAP; mom said pt appeared to be having hallucinations & sz; seen in ER MD felt not related to vax; feb sz;
"KIDNEY PAIN" Narrative: STATES"KIDNEY PAIN ALL DAY EVERY DAY SINCE INJECTION" GOING TO DOCTOR TODAY
9/5/15-pt. came into rx with redness and raise skin at and around site of injection (L) arm- approx. 4"x3" and 2x2"-under that. Patient complained of SOB and soreness of the back upper middle. Patient states that she has asthma and was pulling plants the day after shot. She was told to go to ER should she have ant difficulty breathing.
I had extreme exhaustion for about 3 days. A severe headache. I slept for about 3 days and my symptoms kind of let up a little bit. I lost my sense of taste and my vision got blurry (still a little blurry now). I too had a runny nose.
9:11 am received injection 9:15 cool feeling from left arm injection site radiating to abdomen 98% on room air pulse 111 bp 141/89 9:21 cool sensation dissipating in arm. Cool sensation in stomach. Benadryl 25mg IM administered. Localized rash at left injection site.  Pulse 111 100% on room air 9:27 still an intermittent cool feeling in stomach
On 3/9/2021 the patient presented to the ED for an allergic reaction. She broke out in hives after showering in the morning. The hives started on her back and spread to her abdomen. The patient was not admitted.
Chills, Fever (100.8), nausea, headache, difficulty breathing, extreme fatigue, joint and back pain (the next day and 1/2 had to walk with a cane, pulse dropped to 46, Friday the injection site was red and itchy down to almost my elbow. I called the health department to report the symptoms but took no further action.  Am slowly recovering.  I did email my Cogan's specialist.
Fever. Tired. Vomit. High fever for days. Back of head hurts.
1 hour after receiving MENACTRA developed flushed face, clammy & weak legs, "feels well''.
the 2nd shot of Moderna hurts a lot for one night but everything's fine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (the 2nd shot of Moderna hurts a lot for one night but everything's fine) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (the 2nd shot of Moderna hurts a lot for one night but everything's fine). At the time of the report, VACCINATION SITE PAIN (the 2nd shot of Moderna hurts a lot for one night but everything's fine) had resolved.            No concomitant medication was reported.    Patient stated that she already got 2 shots of Moderna early January where she experienced a bit of headache, a rash mosquito bite but not itchy and her arm was sore. And then she went and got her booster shot from Pfizer a few days ago, and she had a red arm and a bit of a headache, she said that there's no side effects at all compared to Moderna, the second shot of Moderna hurts a lot for one night but everything's fine.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity received in the Moderna  were missed to be booked-in.   This case was linked to MOD-2021-019829 (Patient Link).
fever, aches, pains, headache by 10pm.  Continuous dizziness, still 8 months later.  I get Inner tremors from May through to now when nervous or tired.   Jerkiness of arms/shoulders.  Head nor body  feeling right.  severe fatigue.  went to emergency room twice.  JUly 8 and July 12 due to shakiness, slurred speech, feeling terrible.  Thought i had stroke on the July 8th.
Mom describes child as autistic.  Child was slow in speech prior to vaccination.  On day of vaccination, child changed his personality.  He never spoke again.  He would not make eye contact.  He stopped pointing at objects and refused to interact with no one.
Exactly one week following getting the vaccine (vaccine on Jan 25, symptoms on Feb 1), I started experiencing itchiness at the injection site, it was swollen and red, with skin very tight around the site. This persisted the same for several days and as of today (Feb 4) it is started to lessen. No pain experienced, just achiness in the arm.
Information has been received from a licensed practical nurse concerning a male (approximately 4 years of age to 15 years of age) who on 01-AUG-2007 was vaccinated with Zostavax (Oka/Merck, lot # 657558/0461U) instead of Varivax (MSD).  Subsequently no adverse experiences have been reported.  Unspecified medical attention was sought.  This is one of several reports received from the same source.  Additional information has been requested.  The nurse reported in follow-up that the packaging for the ZOSTAVAX (Merck) and VARIVAX was similar and the 2 vaccines werew stored in the same freezer. The VARIVAX had run out and the ZOSTAVAX (Merck) was picked mistakenly. The nurse hoped to avoid this event in the future. There have been positive results noted from the parents of the vaccinated child.  This is one of several reports received from the same source.  Additional information is not expected.
March 25, 8 days after vaccine, noted mild itching at site in the morning and during the day, when getting ready for bed at about 11:30PM, site still itchy and have a  red slightly raised area approximately  1 1/2  x 2 1/2 inches at vaccine site.  Noting some increase of allergy type symptoms over the day-congestion, itchy mild sore throat, typical for me-tree pollens.  Took Claritin this morning, taking  Benedryl, 25 Mg  at midnight.
injection pain, lymph nodes swelled major fatigue, muscle & server joint pain vomiting and slight fever. cough start and is contiunued~ WEAKNESS.
Had flu shot on Wed. 9/23/09 and on Thursday had muscle tighness in back and pain in shoulder and on Fri. the back pain was even worse.  Went to chiropracter on Mon. Improving with therapy by chiropracter
received a dose of the Moderna COVID-19 Vaccine that expired on July 25th; This spontaneous case was reported by a pharmacist and describes the occurrence (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th). On 27-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.
PATIENT STATED SHE FINISHED HER GROCERY SHOPPING, LEFT THE STORE AND DECIDED TO GO GET SOMETHING TO EAT.  THIS WAS ABOUT AN HOUR OR SO LATER. THE BUSINESS SHE WENT INTO TO ORDER A SANDWHICH SHE NEVER GOT TO ORDER.  PATIENT STATED SHE GOT A LITTLE AND WHEN SHE WOKE UP THE EMERGENCY SERVICES WERE THERE.  SHE HAD THROWN UP BILE THEY TOLD HER.  EMERGENCY SERVICES SAID ALL HER VITALS WERE NORMAL.  PATIENT DECLINED TO GO TO THE HOSPITAL SINCE THEY COULD NOT DETECT ANYTHING WRONG. PATIENT CAME INTO THE PHARMACY TO LET US KNOW ABOUT WHAT HAPPENED AND WAS DOING OKAY.  WE ARE NOT SURE IF IT HAD SOMETHING TO DO WITH THE IMMUNIZATION OF JUST THE FACT SHE HAD NOT EATEN ANYTHING YET.  BEFORE I CLOSE THE PHARMACY I CALLED THE PATIENT TO CHECK ON HER. SHE THANKED ME AND SAID EVERYTHING WAS BACK TO NORMAL.