chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered with vaccine which was beyond the use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist's stated that the beyond the use date is 09Dec2021 at 10:00PM. No concomitant medication provided. No treatment information were provided.
Fever, cold, can not sleep, diarrhea, shaking trembling , light headache, body ache, sharp pain in left shoulder, blurry vision on 2nd day.  Take Tylenol, aspirin. Stop all other medicine. Blurry vision, on 2nd day.
PT is a 17 y.o. female who presents to the ED with complaint of chest pressure that is generalized.  She states that this began about 30 minutes after receiving her second Covid vaccine.  She states that she does not have any shortness of breath currently but reports a sensation of shortness of breath.  She states that she has had a headache for "weeks" she states that this headache has been unrelieved with medication including ibuprofen and acetaminophen as well as allergy medication that she has taken 2 doses of.
Lump in her collar bone, on the left side; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Lump in her collar bone, on the left side) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, the patient experienced MASS (Lump in her collar bone, on the left side). At the time of the report, MASS (Lump in her collar bone, on the left side) had not resolved.            Patient reported that lump in her collar bone was still there till 23Nov2021.   No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-396004 (Patient Link).
The pt received the vax about 9:30 AM on 4/7/00. 1 hour later the child started with a fever of 101, complained of a headache. Fever then increased to 102 and Motrin was given by Mom, Mom then called the MD who said to bring the child to his office after lunch. Temp was 103 at MD's office and then increased again to 104. Cool cloths and Motrin / Tylenol alternately given brought temp down, when not given temp would rise to 101. Child was re - examined by MD and the MD found tonsillitis on 3/7/00. An antibiotic was prescribed and the child is responding well.
16 year old female developed edema, rash and pruritus within 24 hours of receiving second Gardasil shot.
Breakthrough case: I tested positive for COVID-19 on 07/15/2021. Headache, Cough, Congested & runny nose, Tired Loss of taste.
Patient hospitalized for two hours for pelvic pressure on 6/29/2021. patient hospitalized for supervision of vaginal delivery. These visits are within 6 weeks of receiving COVID vaccination. Per doctor notes she delivered a healthy baby boy.
Boostrix given instead of Infanrix; Patient under the age of 2 years old received a dose of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 17-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 34FR4, expiry date 23-SEP-2024) for prophylaxis.   On 05-JAN-2023, the patient received Boostrix. On 05-JAN-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Boostrix given instead of Infanrix) and inappropriate age at vaccine administration (Verbatim: Patient under the age of 2 years old received a dose of Boostrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2023056836   Additional Information: GSK Receipt Date: 18-APR-2023 The reporter stated that they gave the incorrect vaccine to the patient. The patient was given Boostrix instead of Infanrix. The medical assistant reported that a patient under the age of 2 years old, received a dose of Boostrix.  No symptoms were reported. The vaccine administration facility is the same as primary reporter. The reporter consented to follow-up via email. The patient received a dose of Boostrix at an inappropriate age instead of Infanrix, which led to inappropriate age at vaccine administration and wrong vaccine used. This case was found as duplicate of case US2023056836. All the information from the case US2023056836 was merged into this case. The case US2023056836 was deleted and this case stand as case of record for this patient.
Information has been received from a physician via a company representative concerning a 39 year old male who on 12-SEP-2012 was vaccinated with a dose of PNEUMOVAX 23 (lot#HOL3581, exp date not provided). On 14-SEP-2012 the patient experienced swelling of the arm, itching, and chills from receiving PNEUMOVAX 23. The patient was seen by the physician and treated with BENADRYL. At the time of report, it was unknown if the patient had recovered. A lot check has been requested by the reporting physician. Additional information has been requested.
Fever of 101.7, chills. Took Tylenol for fever which was effective. Advised to let them know if symptoms continue for more than two days.
12/31/20 Severe dizziness with vertigo and loss of balance with any movement accompanied by nausea. 1/1/21 headache along with previous symptoms. 1/2/21 symptoms better with a little bit of dizziness with walking or bending over.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (strength, dose and frequency were unknown; lot # was L048468 with expiration date 02-DEC-2017). No adverse effects were reported. This is one of several reports that received from the same reporter. Additional information has been requested.
1.Taste buds tingling when drinking coffee 2. Entire body felt like I had covid. Hit by a bus.
Pt did not have adverse events but was not eligible to receive 2nd booster since he was under 50 and not immunocompromised
Erythema measuring 4.5 in x 7.5 surrounding injection site with edema, itch, and pain
Patient came with mother for booster dose. She was already nervous and expressed her fear for needles. She got immunized and 2 minutes after the administration and while waiting for her mother to received her shot, she fainted. She was still conscious but dizzy. When she fell, the hit her head with a cabinet on the room but she did not complained about head hurting at that moment or signs of blood. Patient was alert and find at 15 minutes after the administration and by the time of leaving the facility.
Menstrual cycle began two weeks early; Menstrual cycle has not stopped; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 19Mar2021 at 14:15 (at the age of 27-year-old), as dose 1, single for COVID-19 immunization. Medical history included shellfish allergy and fish allergy. Concomitant medication received within 2 weeks of vaccination included ethinylestradiol, levonorgestrel (MARLISSA) for birth control from an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021, the day after vaccination, the patient had menstrual cycle which was two weeks early. On an unknown date in Mar2021, the menstrual cycle had not stopped. The patient did not receive any treatment for the event experienced. The event neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The clinical outcome of the event menstrual cycle, which was two weeks early and had not stopped was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Event Onset Latency left as auto-calculated value for event Menstrual cycle shortened.
Fatigue set in within thirty minutes and continues 20 hours later. Very sore left arm happened within a couple hours. Muscle/joint aches within 17 hours.
Patient reports chest tightness that started shortly after getting the vaccine and continuing the next day. He informed me of this 4/20/22. He spoke with his pulmonologist office, and was told it was most likely seasonal allergies. He has an appointment with his primary care provider 4/21/22.
Leg swollen to 1.5 inch larger diameter, red from shot site to knee, hot to touch.
Swollen, Itchy arm for three days, first night I kept getting up to Pee and the next day I slept the entire day.   My second shot, same reaction, but still do not feel well. Also had temperature of 100 both shots
Dose administered greater than 12 hours after initial vial puncture; Vial was not stored in refrigerator and administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture) and PRODUCT STORAGE ERROR (Vial was not stored in refrigerator and administered to patient) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesteremia, Osteoarthritis, Anxiety, Blood pressure and Insomnia. Concomitant products included SPIRONOLACTONE, CARVEDILOL and AMLODIPINE for Blood pressure, ROSUVASTATIN for Cholesterol high, ALPRAZOLAM for Insomnia.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Vial was not stored in refrigerator and administered to patient). On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture) and PRODUCT STORAGE ERROR (Vial was not stored in refrigerator and administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Updated reporter information, patient demographics, Added past relevant history, and updated vaccine dose details, and added concomitant medications.
Four hours after ingesting first Vivotif typhoid pill, began to experience abdominal pain.  Pain persisted for several hours, acute for about one hour.  About 7 hours after ingesting pill, experienced diarrhea.
Pt recv vax on 11/3/98; 3 hr later pt exp swollen/red/watery eyes, low back pain, thigh pain, chills; tx=ice for eyes & Tylenol
Patient was due for Prevnar 20 immunization.  High dose flu vaccine was given by mistake.  Discussed with provider and was given ok to administer Prevnar 20.  Pt was informed of error, pt showed no signs or symptoms of distress prior or after administration.  Let pt know getting a 2nd flu vaccine within the flu season, following one previously given will not cause any harm or ill effect.
Patient observed by LVN at 1400 started experiencing numbness and tingling to left arm. Vital signs B/P 107/68 HR 80 RR 18 O2 99 T 97.8. Supervisor notified, Doctor on call made aware cleared patient to leave observation. Patient left with no signs of distress instructed to follow up and notify with private MD or emergency room if symptoms worsen.
It was chest pain. In Mid-March I had dizzy spells.  I saw my PCP in December who referred my to a Cardiologist three times.
The physician has prescribed meds to treat these symptoms, giving me a diagnosis of conjunctivitis; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 06Mar2021 at 10:45 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperlipidemia, osteopenia, arthritis, pre-diabetic. The patient was allergic to pork, dust and mold. 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 vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN) and vitamins(MANUFACTURER UNKNOWN); all taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously took pethidine hydrochloride (DEMEROL) for an unknown indication on an unknown date and experienced drug allergy. On 06Mar2021 at 21:30, the patient experienced skin irritation around eyelid of right eye, commencing about 12 hours post injection. The irritation progressively increased and then went to a lesser degree to left eye. After patient's efforts to treat it with OTC items, it failed to help, six days post vaccination. The patient received prescribed medications by the doctor to treat these symptoms and was diagnosed of conjunctivitis on 12Mar2021. As per physician's advice, the patient had urged to see an ophthalmologist, which patient will do Monday. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with hydroxyzine (MANUFACTURER UNKNOWN), prednisone (MANUFACTURER UNKNOWN) and mometasone (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events eyelid irritation and conjunctivitis were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
CHEST CONGESTION; SHORTNESS OF BREATH; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patients experienced chest congestion, and shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest congestion and shortness of breath was not reported. This report was non-serious.
Pt received Varivax #1 and Hib #2 in left thigh. About 6 hours later had face, eye and generalized body swelling with pink color to skin. Pt's mom reported that +SOB/cough. When pt seen in ED, no resp. distress, but generalized swelling.
1:59pm- AR nurse heard patient coughing while she was sitting in Covid Observation Area. Assisted patient into Covid monitoring area. Patient continued to have intense episodes of coughing up mucus and phlegm. Accompanied by her sister, who states patient is allergic to a lot of things. Patient states she premedicated with Alka Seltzer Plus 1 tablet this morning at 10 am and took another Alka Seltzer Cold tablet 3-4 minutes after receiving Pfizer booster today, when she noticed the itching in her throat. Patient able to speak in complete sentences in between coughing episodes. States she premedicated with Alka Seltzer Cold Medication tablet prior to 2nd dose of Pfizer, did not have a reaction and thought she would be ok with the booster dose today. Patient denies any difficulty breathing or throat closing. No swelling noted to face, lips or tongue. States left eye feels itchy.  2:02- Patient continues to have intense episodes of coughing up phlegm. States her throat is beginning to feel better, eye itching feels the same. Denies any difficulty breathing, swallowing or speaking.   VS: BP 154/94, HR 80, RR 20, 02 SATs 99% RA  2:07 PM- Call placed to on call provider, Dr. informed of patient symptoms above and that she just took Alka Seltzer Plus Cold tablet that contains antihistamine Chlorpheniramine maleate 2 mg, Aspirin 325 mg and nasal decongestant Phenylephrine  Bitartrate 7.8 mg . Lungs clear to auscultation, no wheezing noted. Per Dr., no need for additional medication at this time. Continue to monitor for additional 15-30 minutes, call back if symptoms not improved. Ok to discharge home if symptoms improved.   2:12 pm-VS: BP 124/84, HR 85, RR 20, 02 SATs 99% RA.  2:15- Patient states lips feel swollen and left eye still itchy. Denies swelling to tongue or throat. Denies any difficulty breathing. Ice pack provided to place on eye and lips to help with itching and swelling.   2:27- VS: BP 133/77, HR 75, RR 20, 100% RA   2:31- Patient states throat feels a little scratchy, but denies itchy or tight feeling.  Patient attributes the scratchy feeling to the coughing. Also states eye itchiness improving with ice pack and reports lip swelling improving.   2:34- Assisted patient to sitting position. States her symptoms have improved, denies eye or throat itching at this time. Encouraged to rest and drink plenty of fluids when she goes home. Advised to seek emergent care or call emergency services for any returning worsening symptoms. Patient and sister verbalized understanding.  2:40 pm- Discharged home from Covid Observation Area in stable condition, accompanied by her sister, who is driving. States she will go to her sister's house to rest.
Hives 3.5 days after 2nd vaccination was administered, along with transient lower lip swelling. Eye swelling appeared 5 days after vaccination.
Receiving doses after the beyond use date/ Thaw expiration date was 3/2/2022, date administered was on 10-May-2022 11:43 AM; Receiving doses after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving doses after the beyond use date) and PRODUCT STORAGE ERROR (Receiving doses after the beyond use date/ Thaw expiration date was 3/2/2022, date administered was on 10-May-2022 11:43 AM) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2022 at 11:43 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-May-2022 at 11:43 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving doses after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Receiving doses after the beyond use date/ Thaw expiration date was 3/2/2022, date administered was on 10-May-2022 11:43 AM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiving doses after the beyond use date) and PRODUCT STORAGE ERROR (Receiving doses after the beyond use date/ Thaw expiration date was 3/2/2022, date administered was on 10-May-2022 11:43 AM) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the HCP administered the vaccine after the beyond use date, as the HCP didn't know that the vials shouldn't be used past 30 days from thawing the vials. Vials were initially stored on 31-Jan-2022. Thaw expiration date was 02-Mar-2022. The vial did not undergo any temperature excursion.  No treatment medications were reported..
My arm got red and swollen about 30 mins after. It's been like that for like a week and a half now. It's less red some days and more red others. It has not spread
26y.o. female with past medical history WPW s/p ablation 2015, hydrocephalus s/p multiple shunts (VTI now lumboperitoneal), seizure disorder, severe persistent asthma without history of intubation, functional stridor, COVID infection in January 2022 presenting for shortness of breath. She had history of admission earlier in the month for asthma exacerbation at which point she was admitted to the hospital and received IV steroids. She improved and was discharged home on steroid taper which she did complete. The last couple days prior to this presentation, she has been feeling more short of breath. Yesterday she was helping her parents move when she began to feel short of breath with wheezing, hoarseness, some chest tightness. She used nebulizer, oral steroid, Benadryl without improvement and decided to seek attention. Plan of Care for: Acute hypoxic respiratory failure secondary to COVID-19 pneumonia + asthma exacerbation ?Scheduled Breathing tx Q.4hrs  ? IV steroids Decadron &  per pulmonology's note from 9/29 "Recommend decreasing steroids from decadron 6mg IV qd to Prednisone 30mg PO qd to complete 5 days"  ? Lovenox
Body aches all over; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches all over) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced PAIN (Body aches all over) and HEADACHE (Headache). At the time of the report, PAIN (Body aches all over) and HEADACHE (Headache) outcome was unknown.            No treatment medications were provided. No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Live follow up received on 13-May-2021: Reporter Contact Information Updated On 07-Jul-2021: follow up received on 07-JUL-2021 and contain no new information
This patient always requests injectables/ immunizations be given in the glute due to little muscle mass in each arm. This injection was given before we were advised that the glute was not a preferable site.