chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 12/13/22, 12 Pfizer Bivalent boosters were administered at two locations.  The two loose unpunctured vials had expiration dates of 12/09/22.  The vaccine had expired 4 days earlier, expirations are on the boxes and not vials so nurse was unaware.  Called, told to complete VAERS and call manufacturer. If not viable: follow CDC guidelines which is to notify client and re-vaccinate in 8 weeks.  Pfizer requested data logger temps and calibration certificate as well as event details. Per Pfizer, we are within the 75 days of stability assessment.
This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown age and gender. On 08-JAN-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # J007946, expiry date: 24-MAR-2016) .5 ml, doses (unspecified in series) intramuscular. No adverse effects were reported. Outcome of the event was not reported. No product quality complaint (PQC) was reported. Reporter considered the event to be not related to RECOMBIVAX HB. This is one of several reports received from the same source (MARRS # 1501USA004956, MARRS # 1501USA004957, MARRS # 1501USA004958, MARRS # 1501USA004959 and 1501USA04960). Additional information has been requested.
Patient complained of patchy redness on upper arm where shot was given. Experienced fever and chills. Flushing of face, burning of ears bit of swelling of tongue. Severe shaky. Patient took BENADRYL for face flushing; TYLENOL for fever.
PT'S FATHER STATES APPROXIMATELY ONE HOUR AFTER RECEIVING GARDASIL SHE BROKE OUT IN A RASH ALL OVER HER BODY. INSTRUCTED TO TAKE BENADRYL. F/U IN ER IF S/S ANAPHYLACTIC SHOCK.
My arm felt very painful all day. It felt heavier, weaker and very sensitive to any touch. The skin on my torso, back, arms and neck quickly became excruciatingly hypersensitive. It was extremely painful even for my clothing or hair to just barely touch my skin. This faded away by morning. It returned the next day but just on my back. It faded in and out. The next day, less but also on my back. Today I don't feel it.
Pharmacist caModerna vaccine more than 6 hours after first vial puncture; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist caModerna vaccine more than 6 hours after first vial puncture) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist caModerna vaccine more than 6 hours after first vial puncture). On 08-May-2021, EXPIRED PRODUCT ADMINISTERED (Pharmacist caModerna vaccine more than 6 hours after first vial puncture) had resolved.        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.   Treatment information not reported. No concomitant medications reported.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for COVID-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "POTS" (unspecified if ongoing), notes: POTS. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result, notes: Paxlovid for COVID-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: Anti-viral details: Paxlovid was started from 08Jun2022 for COVID-19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Right away was irritated had some itching started in sensitive areas of the body and has spread pretty much throughout most of her body red dots almost confluent itches a lot.
Fever, significant body pain, headache, nausea, Diarrhea   The symptoms were not mild, they were equivalent to a full on flu experience.
Tangling of the tongue; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOMFORT (Tangling of the tongue) and PAIN IN EXTREMITY (Sore Arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Dental treatment NOS. Concomitant products included CALCIUM, VITAMIN D NOS, GLUCOSAMINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TONGUE DISCOMFORT (Tangling of the tongue) and PAIN IN EXTREMITY (Sore Arm). At the time of the report, TONGUE DISCOMFORT (Tangling of the tongue) and PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
PATIENT ARRIVED TO THE DOCTOR'S OFFICE (WHO ALSO VACCINATED THE PATIENT 2 DAYS BEFORE)VOMITING, WITH DIARRHEA AND HEADACHE. WAS TREATED WITH PREVACID, IMODIUM, STRICT DIET AND PHENELGAM (INJECTED)
Itchy throat, twitching, chest tightness, and redness on skin. Symptoms developed 20 minutes after the dose was given. Vital signs were assessed by LVN in the observation area. VS stable and within normal range: 97.9 F, SPO2 99% RA, HR 92 regular, BP 138/98. Patient was offered water and given an ice pack. Benadryl 25 mg was given by LVN at 1:13pm, patient refused epi-pen as she had a severe reaction in the past. Patient placed on cot in a private area with a nurse while EOA called EMS on 1:18pm. Ambulance arrived on site at 1:35pm and patient was further assessed. Ambulance left with patient at 1:45pm along with patient's mother.
I have been off work for 2 days so far due to side effects from the booster dose.   24-28 hours after the vaccination, I had a fever of 101.5, muscle pain. Chills. Fatigue.  It?s been 2 days since vaccination and temp is 99.1, chills, fatigue continue which makes it impossible for me to work for my employer.
Clinician began to administer vaccine to patient. Due to a malfunction of the syringe, part of the moderna was leaked out of the side of the needle. Dose was determined to be not administered fully so another dose was approved for the patient.
Fatigue, aches, fever (max 101.3), sore throat, gagging, vomiting x 2
blood pressure at 170/104...my normal high is 135/85; Extreme leg cramping in left leg; Headache; interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Jan2023 at 15:15 as dose 3 (booster), single (Lot number: Gj6742 RA4063) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure controlled" (unspecified if ongoing), notes: High blood pressure controlled. Concomitant medication(s) included: LISINOPRIL; EFFEXOR; STATIN [NYSTATIN]. Vaccination history included: moderna (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 01Oct2021, when the patient was 61-year-old, for COVID-19 immunization; moderna (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 29Apr2022, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Jan2023, outcome "unknown"; MUSCLE SPASMS (non-serious) with onset 13Jan2023 at 01:00, outcome "recovered" (Jan2023), described as "Extreme leg cramping in left leg"; HEADACHE (non-serious) with onset 13Jan2023 at 01:00, outcome "recovered" (Jan2023); HYPERTENSION (medically significant) with onset 13Jan2023 at 01:00, outcome "recovered" (Jan2023), described as "blood pressure at 170/104...my normal high is 135/85". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 135/85; (unspecified date) 120/72; (13Jan2023) 170/104. Therapeutic measures were not taken as a result of hypertension, muscle spasms, headache.  Clinical course: Extreme leg cramping in left leg which woke me. Headache next morning and blood pressure at 170/10. My normal high is 135/85. And normally 120/72. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. Patient had no known allergies.
Injection was given on 1-31-14. It stayed sore, swollen, itchy and red all weekend I couldn't sleep on it due to soreness.
pt recvd vax;devel redness, swelling & tenderness at inject site, lasted 2 days;
the appointment the patient had gotten for her second dose was 47 days after the first shot; A spontaneous report  was received from a consumer concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and got the appointment for his second dose 47 days after the first shot (inappropriate schedule of product administration).  The patient's medical history was not reported. Concomitant product use was not reported.  On 11 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection and had gotten the appointment for his second dose 47 days after the first shot on 30 Mar 2021.  Treatment information was also not provided .  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event was considered as unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-034913:Wife's case
a 18 years old patient was inadvertently administered an expired dose of Menactra; Initial information received on 15-Jul-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a 18 years old male patient who was inadvertently administered an expired 0.5ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U5917AA via intramuscular route in the left deltoid on 15-Jul-2019.  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) for Immunisation.  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 prospective pregnancy report as received from a consumer refers to a 37 year old female patient with drug reactions/allergy to penicillin, sulfa drugs and LEVAQUIN. The patient was pregnant and she was currently at gestation week 38. The patient became pregnant with last menstrual period (LMP) of approximately 17-DEC-2014 and estimated delivery date (EDD) of approximately 23-SEP-2015. On 03-SEP-2015, the patient received a dose of GARDASIL injection or GARDASIL 9 injection (dose, lot# and expiration date were not reporter) instead of an unspecified Flu vaccine at her physician's office. The reporter was uncertain which vaccine was administered. The patient also experienced some injection site swelling and hardness which was not currently resolved. She had also developed "a cold". Pregnancy exposure was approximately at 37 weeks gestation age. The trimester of exposure was approximated to third. The pregnancy outcome and fetal outcome were unknown at the time of the report (the patient was still pregnant). No treatment was given for the adverse events. The outcome of the adverse events was reported as not recovered. The patient sought medical attention via office visit. The causality between the adverse events and reported vaccination was not provided. Additional information has been requested.
I started my menstrual cycle on 1/4/22. I received my booster on 1/5/22. I noticed my menstrual cycle completely stopped a few hours after getting the booster. My menstrual cycle resumed on 1/6/22 around 12:00 PM. Flow was light to moderate which is normal for the 3rd day of my cycle. Rest of menstrual cycle has continued normally.
Chills; Body Ache; Headache; Lymph node swelling under injectionsite Arm and neck ( Size of Lemon); This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8729) via an unspecified route of administration in the left arm on 10Apr2021 at 09:15 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613) via an unspecified route of administration in the left arm on 20Mar2021 at 09:15 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 01:00, the patient experienced chills, body ache, headache, lymph node swelling under the injection site arm and neck (size of a lemon). The adverse 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 reported events. The clinical outcome of the events chills, body ache, headache and lymph node swelling under injection site arm and neck (size of a lemon) were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
evening of vax pt exp body aches, fever (degree unk), malaise, chills;no sx next morning;
5 minutes after the shot, dizziness, sweating underarms, hot, nausea.  Rested for 30 minutes at the pharmacy.  4 hours later. 9:30 PM. Fatigue EXTREME, dizziness when turning head quickly.
Patient is a 75 y.o. male patient of an MD with history of COPD, chronic respiratory failure on 4 L, HFpEF, GERD, chronic hepatitis C, HLD, chronic pain syndrome, and PAH who presented to the Medical Center with shortness of breath and found to have acute on chronic respiratory failure due to COPD exacerbation. Hospitalization complicated by COVID with worsening respiratory failure requiring bipap and transfer to ICU 11/21.   Acute on chronic respiratory failure - improving Hypoxia on admission due to COPD exacerbation Wears 5L O2 at home Worsening hypoxia requiring max bipap 11/12 due covid Pulm following, appreciate assistance Started on Veletri, completed 11/30 Weaned from HHF to nasal cannula, now on 4L Diuresed with IV lasix, now on PO    Covid-19 Virus Infection Bacterial pneumonia Worsening hypoxia; covid positive 11/12 Vaccinated  with CXR showing bibasilar atelect vs PNA Completed course of rocephin/doxy  Completed 10d decadron (done 11/26) No remdesivir due to CKD Out of isolation on 11/24    Acute COPD exacerbation Pulmonary fibrosis Acute COPD exacerbation POA Completed course of decadron and azithromycin IV solumedrol started 11/26  Weaned back to chronic home dose prednisone 10mg 11/28 Continue bronchodilators and symbicort Follows with pulm outpt   UTI U/A consistent with infection; rocephin started 12/2 Urine culture contaminated Switched Rocephin to Keflex 12/3  Ileus - resolved Chronic constipation  Distention increased 11/21  S/p decompression from above GI consulted; on linzess, relistor, reglan (stopped 12/5), and miralax; signed off 12/6 Neostigmine 11/25-11/26 BMs daily, decrease BR Repeat KUB 12/7 with improved ileus Tolerating diet C-scope 12/8  with multiple polyps s/p resection and significant looping secondary to severely redundant, tortuous and elongated colon. GI recs repeat C-scope in 3 years and Barium enema in 2 weeks to evaluate R colon.    Pulmonary hypertension Chronic HFpEF Elevated troponin  Echo 11/2021 with EF 50-55%  Elevated troponin likely due to demand ischemia Follows with Dr. out pt; consulted Continue home toprol and lasix Lasix changed to IV; increased 11/28; Change to PO Lasix 12/7   CKD stage III Baseline Cre ~1.25 Stable   DMT2 A1c 6.5 On SSI; stop 11/29
This spontaneous report was received from a Licensed Practical Nurse referring multiple unspecified patients of unknown age and genders whom on unknown dates, received unspecified doses of improperly stored PROQUAD (Merck) (Lot #, doses, route and sites of administration not reported). This is one of 8 reports from the same source. No additional information provided. Additional information has been requested.
Fever, severe chills/violent shivering, extreme fatigue, loss of appetite, diarrhea, muscle/body aches, prolonged pain at injection site
I received the 2nd dose on 10/6/21. On 10/13/21 I developed pain in my left ear. I thought I was getting an ear infection. By 10/15/21, my left eye had drooped and the pain was a feeling of "pins and needles." This presentation was similar to my diagnosis of bells palsy with associated neuropathy in 2017. My face had recovered from the episode in 2017 but it seems I am back to looking like a stroke victim at 33!
solution got on her eye.; solution got on her eye. It was irritated/patient's eye was irritated; patient's eye was irritated and stinging; solution got on her eye. It was irritated, "not super red" and stinging pain; Adult Dose; Not a full dose--some sprayed into eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 23 year-old female patient received bnt162b2 (COMIRNATY), administration date 23Dec2021 (Lot number: FD7218, Expiration Date: 28Feb2022) at the age of 23 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: ACCIDENTAL EXPOSURE TO PRODUCT (non-serious) with onset 23Dec2021, outcome "unknown", described as "solution got on her eye."; EYE IRRITATION (non-serious) with onset 23Dec2021, outcome "unknown", described as "solution got on her eye. It was irritated/patient's eye was irritated"; EYE PAIN (non-serious) with onset 23Dec2021, outcome "unknown", described as "patient's eye was irritated and stinging"; OCULAR HYPERAEMIA (non-serious) with onset 23Dec2021, outcome "unknown", described as "solution got on her eye. It was irritated, "not super red" and stinging pain"; UNDERDOSE (non-serious) with onset 23Dec2021, outcome "unknown", described as "Adult Dose; Not a full dose--some sprayed into eye". Therapeutic measures were taken as a result of eye irritation, eye pain, ocular hyperaemia.  Additional information: Caller asked about the Pfizer COVID-19 Vaccine Purple Cap presentation. No other products. No investigation assessment. Caller stated that she is calling about the Pfizer Covid 19 Vaccine Adult Dose. Caller stated that one of the pharmacy interns was drawing up a dose from the vial and the air pressure must have been too high because when she pulled the syringe out, the product sprayed, and it got in her eye. Caller stated that the patient's eye was irritated, "not super red" and stinging pain. Caller stated they rinsed it out in the sink and with eye wash. She washed it with saline. Eye contact: Rinsed thoroughly with plenty of water for at least 15 minutes, lifting lower and upper eyelids. Consulted a physician. Caller wanted to know if there are any further instructions for this. Caller was asking is there anything else they should do or any procedures to follow. Treatment received was eye rinse.  Follow-up attempts are completed. No further information is expected.
Mild swelling at injection site <0.5 inch, denies redness, fever. Pain when patient touched injection site.
Diarrhea immediately after getting home, nasal congestion beginning 02/01/2017 around 8:00 AM that led to choking/coughing, struggling to breath.
Patient received first dose of SHINGRIX vaccine on 10/27/21. He came in today with swelling around his eye. He stated that his doctor thinks that he has an infection around his eye as a result of the shingles vaccine. He got a prescription of cefdinir on 11/4/21 but states that the infection is getting worse. I recommended to him that if the antibiotics arent resolving the infection that he should be evaluated again by a physician. Since his prescriber's office is closed, I recommended he follow up with either the urgent care or the ER.
Four days after the vaccine I lost feeling on the left side of my face and tongue. I was also having trouble finding words. I visited my doctor and they assessed me visually. I was also getting Migraine headaches. I had ocular issues on the left side with the headaches which were a daily event. They were consistent for the whole day.  I went back the next day after being called and I went to the ER. My D-Dimer was elevated but my other tests were normal. I felt very bad, and I was having flashes of pain across my body. Those continued for four to five weeks. The Migraines also persisted during that time. Over the counter Tylenol and Advil did not work. A growth in my right thigh was discovered during that time. It was about the size of an Almond.  It was identified as a Hematoma. I feel better now after eight weeks and I am starting to work out again. I am scheduled for a follow up on the Hematoma in my thigh.